Trial · NCT05981365
Voxelotor CYP and Transporter Cocktail Interaction Study
NCT05981365, Phase 1, Completed, Pfizer; results first posted 2024-11-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Voxelotor CYP and Transporter Cocktail Interaction Study. Trials, record NCT05981365. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05981365
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Voxelotor CYP and Transporter Cocktail Interaction Study
- NCT number
- NCT05981365
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 44 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Sickle Cell Disease
- Interventions
- Voxelotor, Bupropion, Repaglinide, Flurbiprofen, Omeprazole, Midazolam, Metformin, Furosemide, Rosuvastatin
- First posted
- 2023-08-08
- Last updated
- 2024-11-22
- Results first posted
- 2024-11-22
Source ClinicalTrials.gov
Registered outcomes66
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part A: Maximum Observed Plasma Concentration (Cmax) for Bupropion | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose on Period 1 Day 1, Period 2 Day 2 and Period 2 Day 12 for Treatment A, D and G, respectively | |
| Primary | Part A: Cmax for Repaglinide | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Period 1 Day 4 and Period 2 Day 6 for Treatment B and F, respectively | |
| Primary | Part A: Cmax for Flurbiprofen | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours post-dose on Period 1 Day 1 and Period 2 Day 4 for Treatment A and E, respectively | |
| Primary | Part A: Cmax for Omeprazole | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours post-dose on Period 1 Day 1 and Period 2 Day 4 for Treatment A and E, respectively | |
| Primary | Part A: Cmax for Midazolam | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours post-dose on Period 1 Day 1 and Period 2 Day 4 for Treatment A and E, respectively | |
| Primary | Part A: Area Under the Plasma Concentration-Time Curve From Time Zero (0) to the Time of the Last Quantifiable Concentration (AUCt) for Bupropion | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose on Period 1 Day 1, Period 2 Day 2 and Period 2 Day 12 for Treatment A, D and G, respectively | AUCt was calculated using the linear/log trapezoidal rule. |
| Primary | Part A: AUCt for Repaglinide | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Period 1 Day 4 and Period 2 Day 6 for Treatment B and F, respectively | AUCt was calculated using the linear/log trapezoid rule. |
| Primary | Part A: AUCt for Flurbiprofen | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours post-dose on Period 1 Day 1 and Period 2 Day 4 for Treatment A and E, respectively | AUCt was calculated using the linear/log trapezoid rule. |
| Primary | Part A: AUCt for Omeprazole | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours post-dose on Period 1 Day 1 and Period 2 Day 4 for Treatment A and E, respectively | AUCt was calculated using the linear/log trapezoid rule. |
| Primary | Part A: AUCt for Midazolam | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours post-dose on Period 1 Day 1 and Period 2 Day 4 for Treatment A and E, respectively | AUCt was calculated using the linear/log trapezoid rule. |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 registered outcomesOutcomes66
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part A: Maximum Observed Plasma Concentration (Cmax) for Bupropion | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose on Period 1 Day 1, Period 2 Day 2 and Period 2 Day 12 for Treatment A, D and G, respectively | Pharmacokinetic (PK) evaluable population included all participants who received at least 1 dose of study drug (voxelotor or cocktail drugs \[probe substrates\]) and had a sufficient PK profile to derive at least 1 PK parameter. | Nanogram per milliliter (ng/mL) | GEOMETRIC_MEAN |
| PRIMARY | Part A: Cmax for Repaglinide | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Period 1 Day 4 and Period 2 Day 6 for Treatment B and F, respectively | PK evaluable population included all participants who received at least 1 dose of study drug (voxelotor or cocktail drugs \[probe substrates\]) and had a sufficient PK profile to derive at least 1 PK parameter. | ng/ml | GEOMETRIC_MEAN |
| PRIMARY | Part A: Cmax for Flurbiprofen | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours post-dose on Period 1 Day 1 and Period 2 Day 4 for Treatment A and E, respectively | PK evaluable population included all participants who received at least 1 dose of study drug (voxelotor or cocktail drugs \[probe substrates\]) and had a sufficient PK profile to derive at least 1 PK parameter. | ng/ml | GEOMETRIC_MEAN |
| PRIMARY | Part A: Cmax for Omeprazole | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours post-dose on Period 1 Day 1 and Period 2 Day 4 for Treatment A and E, respectively | PK evaluable population included all participants who received at least 1 dose of study drug (voxelotor or cocktail drugs \[probe substrates\]) and had a sufficient PK profile to derive at least 1 PK parameter. | ng/ml | GEOMETRIC_MEAN |
| PRIMARY | Part A: Cmax for Midazolam | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours post-dose on Period 1 Day 1 and Period 2 Day 4 for Treatment A and E, respectively | PK evaluable population included all participants who received at least 1 dose of study drug (voxelotor or cocktail drugs \[probe substrates\]) and had a sufficient PK profile to derive at least 1 PK parameter. | ng/ml | GEOMETRIC_MEAN |
| PRIMARY | Part A: Area Under the Plasma Concentration-Time Curve From Time Zero (0) to the Time of the Last Quantifiable Concentration (AUCt) for Bupropion | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose on Period 1 Day 1, Period 2 Day 2 and Period 2 Day 12 for Treatment A, D and G, respectively | PK evaluable population included all participants who received at least 1 dose of study drug (voxelotor or cocktail drugs \[probe substrates\]) and had a sufficient PK profile to derive at least 1 PK parameter. | Hour* nanogram/milliliter (h*ng/mL) | GEOMETRIC_MEAN |
| PRIMARY | Part A: AUCt for Repaglinide | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Period 1 Day 4 and Period 2 Day 6 for Treatment B and F, respectively | PK evaluable population included all participants who received at least 1 dose of study drug (voxelotor or cocktail drugs \[probe substrates\]) and had a sufficient PK profile to derive at least 1 PK parameter. | h*ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Part A: AUCt for Flurbiprofen | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours post-dose on Period 1 Day 1 and Period 2 Day 4 for Treatment A and E, respectively | PK evaluable population included all participants who received at least 1 dose of study drug (voxelotor or cocktail drugs \[probe substrates\]) and had a sufficient PK profile to derive at least 1 PK parameter. | h*ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Part A: AUCt for Omeprazole | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours post-dose on Period 1 Day 1 and Period 2 Day 4 for Treatment A and E, respectively | PK evaluable population included all participants who received at least 1 dose of study drug (voxelotor or cocktail drugs \[probe substrates\]) and had a sufficient PK profile to derive at least 1 PK parameter. | h*ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Part A: AUCt for Midazolam | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours post-dose on Period 1 Day 1 and Period 2 Day 4 for Treatment A and E, respectively | PK evaluable population included all participants who received at least 1 dose of study drug (voxelotor or cocktail drugs \[probe substrates\]) and had a sufficient PK profile to derive at least 1 PK parameter. | h*ng/mL | GEOMETRIC_MEAN |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 outcomesResults by group147
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part A: Maximum Observed Plasma Concentration (Cmax) for Bupropion | Part A: Period 1: Treatment A | 160.5 | Geometric Coefficient of Variation 31 | Nanogram per milliliter (ng/mL) | |
| Part A: Maximum Observed Plasma Concentration (Cmax) for Bupropion | Part A: Period 2: Treatment D | 201.3 | Geometric Coefficient of Variation 35 | Nanogram per milliliter (ng/mL) | |
| Part A: Maximum Observed Plasma Concentration (Cmax) for Bupropion | Part A: Period 2: Treatment G | 191.1 | Geometric Coefficient of Variation 36 | Nanogram per milliliter (ng/mL) | |
| Part A: Cmax for Repaglinide | Part A: Period 1: Treatment B | 10.85 | Geometric Coefficient of Variation 41 | ng/ml | |
| Part A: Cmax for Repaglinide | Part A: Period 2: Treatment F | 12.89 | Geometric Coefficient of Variation 37 | ng/ml | |
| Part A: Cmax for Flurbiprofen | Part A: Period 1: Treatment A | 6923 | Geometric Coefficient of Variation 25 | ng/ml | |
| Part A: Cmax for Flurbiprofen | Part A: Period 2: Treatment E | 7820 | Geometric Coefficient of Variation 20 | ng/ml | |
| Part A: Cmax for Omeprazole | Part A: Period 1: Treatment A | 458.1 | Geometric Coefficient of Variation 58 | ng/ml | |
| Part A: Cmax for Omeprazole | Part A: Period 2: Treatment E | 374.3 | Geometric Coefficient of Variation 57 | ng/ml | |
| Part A: Cmax for Midazolam | Part A: Period 1: Treatment A | 10.33 | Geometric Coefficient of Variation 38 | ng/ml |
1 to 10 of 147Source ClinicalTrials.gov
See all 147 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 | STARTED | Part A:Treatment Sequence ABCDEFG | 26 | |
| Period 1 | STARTED | Part B: Treatment Sequence ABCD | 18 | |
| Period 1 | COMPLETED | Part A:Treatment Sequence ABCDEFG | 25 | |
| Period 1 | COMPLETED | Part B: Treatment Sequence ABCD | 18 | |
| Period 1 | NOT COMPLETED | Part A:Treatment Sequence ABCDEFG | 1 | |
| Period 1 | NOT COMPLETED | Part B: Treatment Sequence ABCD | 0 | |
| Washout Period | STARTED | Part A:Treatment Sequence ABCDEFG | 25 | |
| Washout Period | STARTED | Part B: Treatment Sequence ABCD | 18 | |
| Washout Period | COMPLETED | Part A:Treatment Sequence ABCDEFG | 25 | |
| Washout Period | COMPLETED | Part B: Treatment Sequence ABCD | 18 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events52
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 | Headache | Nervous system disorders | Part A: Period 1 | 0 | 26 | |
| other | Headache | Nervous system disorders | Part A: Period 2 | 7 | 25 | |
| other | Headache | Nervous system disorders | Part B: Period 1 | 1 | 18 | |
| other | Headache | Nervous system disorders | Part B: Period 2 | 2 | 18 | |
| other | Dizziness | Nervous system disorders | Part A: Period 1 | 0 | 26 | |
| other | Dizziness | Nervous system disorders | Part A: Period 2 | 1 | 25 | |
| other | Dizziness | Nervous system disorders | Part B: Period 1 | 0 | 18 | |
| other | Dizziness | Nervous system disorders | Part B: Period 2 | 0 | 18 | |
| other | Somnolence | Nervous system disorders | Part A: Period 1 | 1 | 26 | |
| other | Somnolence | Nervous system disorders | Part A: Period 2 | 0 | 25 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: Period 1 | 0 | 26 |
| Total, all-cause mortality | Part A: Period 2 | 0 | 25 |
| Total, all-cause mortality | Part B: Period 1 | 0 | 18 |
| Total, all-cause mortality | Part B: Period 2 | 0 | 18 |
| Total, other adverse events | Part A: Period 1 | 4 | 26 |
| Total, other adverse events | Part A: Period 2 | 9 | 25 |
| Total, other adverse events | Part B: Period 1 | 1 | 18 |
| Total, other adverse events | Part B: Period 2 | 2 | 18 |
| Total, serious adverse events | Part A: Period 1 | 0 | 26 |
| Total, serious adverse events | Part A: Period 2 | 0 | 25 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Part A: Period 1 vs Part A: Period 2: Part A: Number of Participants With Clinically Significant Abnormalities in Vital Signs | Trial comparisons |
| Part A: Period 1 vs Part A: Period 2: Part A: Number of Participants With Clinically Significant Abnormalities in Laboratory Tests | Trial comparisons |
| Part B: Period 1 vs Part B: Period 2: Part B: Number of Participants With Clinically Significant Abnormalities in Vital Signs | Trial comparisons |
| Part B: Period 1 vs Part B: Period 2: Part B: Number of Participants With Clinically Significant Abnormalities in Physical Examinations | Trial comparisons |
| Part A: Period 1 vs Part A: Period 2: Part A: Number of Participants With Clinically Significant Abnormalities in Physical Examinations | Trial comparisons |
| Part B: Period 1 vs Part B: Period 2: Part B: Number of Participants With Clinically Significant Abnormalities in Laboratory Tests | 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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05981365
GET https://conductscience.org/api/trials/v1/NCT05981365/registered?page=2