Trial · NCT02804399
A Study To Evaluate The Effect Of Rifampin On Pharmacokinetics Of PF-06463922 In Healthy Volunteers
NCT02804399, Phase 1, Completed, Pfizer; results first posted 2019-01-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study To Evaluate The Effect Of Rifampin On Pharmacokinetics Of PF-06463922 In Healthy Volunteers. Trials, record NCT02804399. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02804399
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study To Evaluate The Effect Of Rifampin On Pharmacokinetics Of PF-06463922 In Healthy Volunteers
- NCT number
- NCT02804399
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 12 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Healthy
- Interventions
- PF-06463922, rifampin
- First posted
- 2016-06-17
- Last updated
- 2019-01-25
- Results first posted
- 2019-01-25
- Limitations and caveats
As all participants receiving co-administration of PF-06463922 (100 mg SD) with rifampin (600 mg QD) experienced drug-induced liver injury AEs, all 12 participants were discontinued from further rifampin treatment after 9 days but not 12 days.
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Plasma AUCinf for PF-06463922 Given Alone and With Rifampin | Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2. | AUCinf is the plasma area under the plasma concentration-time profile from time 0 extrapolated to infinite time. The pharmacokinetics (PK) parameter analysis population was defined as all participants enrolled and treated who have at least 1 of the PF-06463922 PK parameters of primary interest in at least 1 treatment period. |
| Primary | Plasma Cmax for PF-06463922 Given Alone and With Rifampin | Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2. | Cmax is the maximum observed plasma concentration. PK parameter analysis population was defined as all participants enrolled and treated who have at least 1 of the PF-06463922 PK parameters of primary interest in at least 1 treatment period. |
| Secondary | Plasma AUClast for PF-06463922 Given Alone and With Rifampin | Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2. | AUClast is the plasma area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. The PK parameter analysis population was defined as all participants enrolled and treated who have at least 1 of the PF-06463922 PK parameters of primary interest in at least 1 treatment period. |
| Secondary | Plasma Tmax for PF-06463922 Given Alone and With Rifampin | Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2. | Tmax is the time for maximum observed plasma concentration (Cmax). The PK parameter analysis population was defined as all participants enrolled and treated who have at least 1 of the PF-06463922 PK parameters of primary interest in at least 1 treatment period. |
| Secondary | Plasma t1/2 for PF-06463922 Given Alone and With Rifampin | Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2. | Terminal plasma half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half. The PK parameter analysis population is defined as all participants enrolled and treated who have at least 1 of the PF-06463922 PK parameters of primary interest in at least 1 treatment period. |
| Secondary | Plasma CL/F for PF-06463922 Given Alone and With Rifampin | Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2. | CL/F is the apparent oral clearance. The PK parameter analysis population was defined as all participants enrolled and treated who have at least 1 of the PF-06463922 PK parameters of primary interest in at least 1 treatment period. |
| Secondary | Plasma Vz/F for PF-06463922 Given Alone and With Rifampin | Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg administration with rifampin in Period 2. | Vz/F is the apparent volume of distribution (only after single dose).The PK parameter analysis population was defined as all participants enrolled and treated who have at least 1 of the PF-06463922 PK parameters of primary interest in at least 1 treatment period. |
| Secondary | Plasma AUClast for PF-06895751 When PF-06463922 Given Alone and With Rifampin | Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2. | AUClast was the plasma area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. The PK parameter analysis population was defined as all participants enrolled and treated who have at least 1 of the PF-06463922 PK parameters of primary interest in at least 1 treatment period. PF-06895751 was the metabolite of PF-06463922. |
| Secondary | Plasma AUCinf for PF-06895751 When PF-06463922 Given Alone and With Rifampin | Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2. | AUCinf was the area under the plasma concentration-time profile from time 0 extrapolated to infinite time. The PK parameter analysis population was defined as all participants enrolled and treated who have at least 1 of the PF-06463922 PK parameters of primary interest in at least 1 treatment period. PF-06895751 was the metabolite of PF-06463922. |
| Secondary | Plasma Tmax for PF-06895751 When PF-06463922 Given Alone and With Rifampin. | Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2. | Tmax was the time for maximum observed plasma concentration (Cmax). The PK parameter analysis population was defined as all participants enrolled and treated who have at least 1 of the PF-06463922 PK parameters of primary interest in at least 1 treatment period. PF-06895751 was the metabolite of PF-06463922. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Plasma AUCinf for PF-06463922 Given Alone and With Rifampin | Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2. | All participants who received PF-06463922, rifampin and PF-06463922 in Period 1 and 2, respectively. A washout period of at least 10 days between the 2 single PF-06463922 dose was maintained. Here, Number of Participants analyzed signifies number of participants evaluable for this outcome measure. | nanogram (ng)*hr/ millilitre (mL) | GEOMETRIC_MEAN |
| PRIMARY | Plasma Cmax for PF-06463922 Given Alone and With Rifampin | Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2. | All participants who received PF-06463922, rifampin and PF-06463922 in Period 1 and 2, respectively. A washout period of at least 10 days between the 2 single PF-06463922 dose was maintained. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Plasma AUClast for PF-06463922 Given Alone and With Rifampin | Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2. | All participants who received PF-06463922, rifampin and PF-06463922 in Period 1 and 2, respectively. A washout period of at least 10 days between the 2 single PF-06463922 dose was maintained. | ng•hr/mL | GEOMETRIC_MEAN |
| SECONDARY | Plasma Tmax for PF-06463922 Given Alone and With Rifampin | Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2. | All participants who received PF-06463922, rifampin and PF-06463922 in Period 1 and 2, respectively. A washout period of at least 10 days between the 2 single PF-06463922 dose was maintained. | hr | MEDIAN |
| SECONDARY | Plasma t1/2 for PF-06463922 Given Alone and With Rifampin | Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2. | All participants who received PF-06463922, rifampin and PF-06463922 in Period 1 and 2, respectively. A washout period of at least 10 days between the 2 single PF-06463922 dose was maintained. Here, Number of Participants analyzed signifies number of participants evaluable for this outcome measure. | hr | MEAN |
| SECONDARY | Plasma CL/F for PF-06463922 Given Alone and With Rifampin | Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2. | All participants who received PF-06463922, rifampin and PF-06463922 in Period 1 and 2, respectively. A washout period of at least 10 days between the 2 single PF-06463922 dose was maintained. Here, Number of Participants analyzed signifies number of participants evaluable for this outcome measure. | L/hr | GEOMETRIC_MEAN |
| SECONDARY | Plasma Vz/F for PF-06463922 Given Alone and With Rifampin | Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg administration with rifampin in Period 2. | All participants who received PF-06463922, rifampin and PF-06463922 in Period 1 and 2, respectively. A washout period of at least 10 days between the 2 single PF-06463922 dose was maintained. Here, Number of Participants analyzed signifies number of participants evaluable for this outcome measure. | liter | GEOMETRIC_MEAN |
| SECONDARY | Plasma AUClast for PF-06895751 When PF-06463922 Given Alone and With Rifampin | Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2. | All participants who received PF-06463922, rifampin and PF-06463922 in Period 1 and 2, respectively. A washout period of at least 10 days between the 2 single PF-06463922 dose was maintained. | ng*hr/mL | GEOMETRIC_MEAN |
| SECONDARY | Plasma AUCinf for PF-06895751 When PF-06463922 Given Alone and With Rifampin | Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2. | All participants who received PF-06463922, rifampin and PF-06463922 in Period 1 and 2, respectively. A washout period of at least 10 days between the 2 single PF-06463922 dose was maintained. Here, Number of Participants analyzed signifies number of participants evaluable for this outcome measure. | ng•hr/mL | GEOMETRIC_MEAN |
| SECONDARY | Plasma Tmax for PF-06895751 When PF-06463922 Given Alone and With Rifampin. | Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2. | All participants who received PF-06463922, rifampin and PF-06463922 in Period 1 and 2, respectively. A washout period of at least 10 days between the 2 single PF-06463922 dose was maintained. | hr | MEDIAN |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group112
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Plasma AUCinf for PF-06463922 Given Alone and With Rifampin | PF-06463922 100 mg | 8766 | Geometric Coefficient of Variation 19 | nanogram (ng)*hr/ millilitre (mL) | |
| Plasma AUCinf for PF-06463922 Given Alone and With Rifampin | Rifampin 600 mg + PF-06463922 100 mg | 1299 | Geometric Coefficient of Variation 30 | nanogram (ng)*hr/ millilitre (mL) | |
| Plasma Cmax for PF-06463922 Given Alone and With Rifampin | PF-06463922 100 mg | 621.4 | Geometric Coefficient of Variation 26 | ng/mL | |
| Plasma Cmax for PF-06463922 Given Alone and With Rifampin | Rifampin 600 mg + PF-06463922 100 mg | 148.4 | Geometric Coefficient of Variation 31 | ng/mL | |
| Plasma AUClast for PF-06463922 Given Alone and With Rifampin | PF-06463922 100 mg | 8597 | Geometric Coefficient of Variation 19 | ng•hr/mL | |
| Plasma AUClast for PF-06463922 Given Alone and With Rifampin | Rifampin 600 mg + PF-06463922 100 mg | 1200 | Geometric Coefficient of Variation 32 | ng•hr/mL | |
| Plasma Tmax for PF-06463922 Given Alone and With Rifampin | PF-06463922 100 mg | 1.50 | Full Range 0.683 to 2.00 | hr | |
| Plasma Tmax for PF-06463922 Given Alone and With Rifampin | Rifampin 600 mg + PF-06463922 100 mg | 1.51 | Full Range 1.00 to 4.00 | hr | |
| Plasma t1/2 for PF-06463922 Given Alone and With Rifampin | PF-06463922 100 mg | 21.22 | Standard Deviation 4.12 | hr | |
| Plasma t1/2 for PF-06463922 Given Alone and With Rifampin | Rifampin 600 mg + PF-06463922 100 mg | 10.16 | Standard Deviation 2.43 | hr |
1 to 10 of 112Source ClinicalTrials.gov
See all 112 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 | STARTED | PF-06463922 100 mg Single Dose (SD) | 12 | |
| Period 1 | STARTED | Rifampin 600 Once a Day (QD) + PF-06463922 100 mg SD | 0 | |
| Period 1 | COMPLETED | PF-06463922 100 mg Single Dose (SD) | 12 | |
| Period 1 | COMPLETED | Rifampin 600 Once a Day (QD) + PF-06463922 100 mg SD | 0 | |
| Period 1 | NOT COMPLETED | PF-06463922 100 mg Single Dose (SD) | 0 | |
| Period 1 | NOT COMPLETED | Rifampin 600 Once a Day (QD) + PF-06463922 100 mg SD | 0 | |
| Washout Period at Least 10 Days | STARTED | PF-06463922 100 mg Single Dose (SD) | 12 | |
| Washout Period at Least 10 Days | STARTED | Rifampin 600 Once a Day (QD) + PF-06463922 100 mg SD | 0 | |
| Washout Period at Least 10 Days | COMPLETED | PF-06463922 100 mg Single Dose (SD) | 12 | |
| Washout Period at Least 10 Days | COMPLETED | Rifampin 600 Once a Day (QD) + PF-06463922 100 mg SD | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events66
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dry eye | Eye disorders | PF-06463922 100 mg | 0 | 12 | |
| other | Dry eye | Eye disorders | Rifampin 600 mg QD | 1 | 12 | |
| other | Dry eye | Eye disorders | Rifampin 600 mg + PF-06463922 100 mg | 1 | 12 | |
| other | Photophobia | Eye disorders | PF-06463922 100 mg | 0 | 12 | |
| other | Photophobia | Eye disorders | Rifampin 600 mg QD | 1 | 12 | |
| other | Photophobia | Eye disorders | Rifampin 600 mg + PF-06463922 100 mg | 1 | 12 | |
| other | Abdominal pain | Gastrointestinal disorders | PF-06463922 100 mg | 0 | 12 | |
| other | Abdominal pain | Gastrointestinal disorders | Rifampin 600 mg QD | 0 | 12 | |
| other | Abdominal pain | Gastrointestinal disorders | Rifampin 600 mg + PF-06463922 100 mg | 1 | 12 | |
| other | Abdominal pain lower | Gastrointestinal disorders | PF-06463922 100 mg | 0 | 12 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PF-06463922 100 mg | ||
| Total, all-cause mortality | Rifampin 600 mg QD | ||
| Total, all-cause mortality | Rifampin 600 mg + PF-06463922 100 mg | ||
| Total, other adverse events | PF-06463922 100 mg | 1 | 12 |
| Total, other adverse events | Rifampin 600 mg QD | 5 | 12 |
| Total, other adverse events | Rifampin 600 mg + PF-06463922 100 mg | 11 | 12 |
| Total, serious adverse events | PF-06463922 100 mg | 0 | 12 |
| Total, serious adverse events | Rifampin 600 mg QD | 0 | 12 |
| Total, serious adverse events | Rifampin 600 mg + PF-06463922 100 mg | 5 | 12 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31863284 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| PF-06463922 100 mg vs Rifampin 600 mg + PF-06463922 100 mg: Number of Participants With Concomitant Treatments Meeting the Criteria of Potentially Significant Clinical Concerns | Trial comparisons |
| PF-06463922 100 mg vs Rifampin 600 mg + PF-06463922 100 mg: Number of Participants With Physical Examination Findings Meeting the Criteria of Potentially Significant Clinical Concern | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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