Trial · NCT04425902
Evaluation of Pharmacokinetic Interaction Between GSK3640254 and Caffeine, Metoprolol, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin in Healthy Adults
NCT04425902, Phase 1, Completed, ViiV Healthcare; results first posted 2022-05-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of Pharmacokinetic Interaction Between GSK3640254 and Caffeine, Metoprolol, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin in Healthy Adults. Trials, record NCT04425902. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04425902
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Pharmacokinetic Interaction Between GSK3640254 and Caffeine, Metoprolol, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin in Healthy Adults
- NCT number
- NCT04425902
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 20 participants, actual
- Lead sponsor
- ViiV Healthcare
- Conditions
- HIV Infections
- Interventions
- GSK3640254 200 mg, Caffeine 200 mg, Metoprolol 100 mg, Montelukast 10 mg, Flurbiprofen 100 mg, Omeprazole 40 mg, Midazolam 5 mg (2.5 mL), Digoxin 0.25 mg, Pravastatin 40 mg
- First posted
- 2020-06-11
- Last updated
- 2024-01-05
- Results first posted
- 2022-05-23
Source ClinicalTrials.gov
Registered outcomes171
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Time t (AUC[0-t]) for Caffeine | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3 | Blood samples were collected at the indicated time points for pharmacokinetic analysis of caffeine. Area under the plasma concentration-time curve from time zero to time t, to be calculated using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid. |
| Primary | AUC From Time Zero Extrapolated to Infinity (AUC[0-infinity]) for Caffeine | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3 | Blood samples were collected at the indicated time points for pharmacokinetic analysis of caffeine. The AUC(0-infinity) was determined using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid. |
| Primary | Maximum Observed Plasma Concentration (Cmax) for Caffeine | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3 | Blood samples were collected at the indicated time points for pharmacokinetic analysis of caffeine. |
| Primary | Time to Cmax (Tmax) for Caffeine | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3 | Blood samples were collected at the indicated time points for pharmacokinetic analysis of caffeine. |
| Primary | Apparent Terminal Phase Half-life (t1/2) for Caffeine | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3 | Blood samples were collected at the indicated time points for pharmacokinetic analysis of caffeine. |
| Primary | AUC(0-t) for Metoprolol | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3 | Blood samples were collected at the indicated time points for pharmacokinetic analysis of metoprolol. The AUC(0-t) was determined using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid. |
| Primary | AUC(0-infinity) for Metoprolol | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3 | Blood samples were collected at the indicated time points for pharmacokinetic analysis of metoprolol. The AUC(0-infinity) was determined using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid. |
| Primary | Cmax for Metoprolol | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3 | Blood samples were collected at the indicated time points for pharmacokinetic analysis of metoprolol. |
| Primary | Tmax for Metoprolol | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3 | Blood samples were collected at the indicated time points for pharmacokinetic analysis of metoprolol. |
| Primary | t1/2 for Metoprolol | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3 | Blood samples were collected at the indicated time points for pharmacokinetic analysis of metoprolol. |
1 to 10 of 171Source ClinicalTrials.gov
See all 171 registered outcomesOutcomes171
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Time t (AUC[0-t]) for Caffeine | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3 | The Pharmacokinetic (PK) Parameter Population included all participants who underwent plasma PK sampling and had evaluable PK parameters estimated. Only those participants with data available at the specified time points were analyzed. | Hour*nanograms per milliliter (h*ng/mL) | GEOMETRIC_MEAN |
| PRIMARY | AUC From Time Zero Extrapolated to Infinity (AUC[0-infinity]) for Caffeine | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3 | PK Parameter Population. Only those participants with data available at the specified time points were analyzed. | h*ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Maximum Observed Plasma Concentration (Cmax) for Caffeine | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3 | PK Parameter Population. Only those participants with data available at the specified time points were analyzed. | Nanograms per milliliter (ng/mL) | GEOMETRIC_MEAN |
| PRIMARY | Time to Cmax (Tmax) for Caffeine | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3 | PK Parameter Population. Only those participants with data available at the specified time points were analyzed. | Hours | MEDIAN |
| PRIMARY | Apparent Terminal Phase Half-life (t1/2) for Caffeine | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3 | PK Parameter Population. Only those participants with data available at the specified time points were analyzed. | Hours | GEOMETRIC_MEAN |
| PRIMARY | AUC(0-t) for Metoprolol | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3 | PK Parameter Population. Only those participants with data available at the specified time points were analyzed. | h*ng/mL | GEOMETRIC_MEAN |
| PRIMARY | AUC(0-infinity) for Metoprolol | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3 | PK Parameter Population. Only those participants with data available at the specified time points were analyzed. | h*ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Cmax for Metoprolol | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3 | PK Parameter Population. Only those participants with data available at the specified time points were analyzed. | ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Tmax for Metoprolol | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3 | PK Parameter Population. Only those participants with data available at the specified time points were analyzed. | Hours | MEDIAN |
| PRIMARY | t1/2 for Metoprolol | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3 | PK Parameter Population. Only those participants with data available at the specified time points were analyzed. | Hours | GEOMETRIC_MEAN |
1 to 10 of 171Source ClinicalTrials.gov
See all 171 outcomesResults by group665
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Time t (AUC[0-t]) for Caffeine | Treatment A: Probe Substrates | 37970 | Geometric Coefficient of Variation 31.1 | Hour*nanograms per milliliter (h*ng/mL) | |
| Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Time t (AUC[0-t]) for Caffeine | Treatment C: Probe Substrates + GSK3640254 200 mg | 42230 | Geometric Coefficient of Variation 32.4 | Hour*nanograms per milliliter (h*ng/mL) | |
| AUC From Time Zero Extrapolated to Infinity (AUC[0-infinity]) for Caffeine | Treatment A: Probe Substrates | 39720 | Geometric Coefficient of Variation 30.6 | h*ng/mL | |
| AUC From Time Zero Extrapolated to Infinity (AUC[0-infinity]) for Caffeine | Treatment C: Probe Substrates + GSK3640254 200 mg | 44440 | Geometric Coefficient of Variation 30.6 | h*ng/mL | |
| Maximum Observed Plasma Concentration (Cmax) for Caffeine | Treatment A: Probe Substrates | 4340 | Geometric Coefficient of Variation 22.1 | Nanograms per milliliter (ng/mL) | |
| Maximum Observed Plasma Concentration (Cmax) for Caffeine | Treatment C: Probe Substrates + GSK3640254 200 mg | 4110 | Geometric Coefficient of Variation 25.9 | Nanograms per milliliter (ng/mL) | |
| Time to Cmax (Tmax) for Caffeine | Treatment A: Probe Substrates | 2.000 | Full Range 1.00 to 6.00 | Hours | |
| Time to Cmax (Tmax) for Caffeine | Treatment C: Probe Substrates + GSK3640254 200 mg | 3.000 | Full Range 0.50 to 6.00 | Hours | |
| Apparent Terminal Phase Half-life (t1/2) for Caffeine | Treatment A: Probe Substrates | 5.380 | Geometric Coefficient of Variation 21.2 | Hours | |
| Apparent Terminal Phase Half-life (t1/2) for Caffeine | Treatment C: Probe Substrates + GSK3640254 200 mg | 6.085 | Geometric Coefficient of Variation 17.4 | Hours |
1 to 10 of 665Source ClinicalTrials.gov
See all 665 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period 1 (Days 1 to 10) | STARTED | All Treated Participants | 20 | |
| Treatment Period 1 (Days 1 to 10) | COMPLETED | All Treated Participants | 20 | |
| Treatment Period 1 (Days 1 to 10) | NOT COMPLETED | All Treated Participants | 0 | |
| Treatment Period 2 (Days 11 to 20) | STARTED | All Treated Participants | 20 | |
| Treatment Period 2 (Days 11 to 20) | COMPLETED | All Treated Participants | 19 | |
| Treatment Period 2 (Days 11 to 20) | NOT COMPLETED | All Treated Participants | 1 | |
| Treatment Period 3 (Days 21 to 26) | STARTED | All Treated Participants | 19 | |
| Treatment Period 3 (Days 21 to 26) | COMPLETED | All Treated Participants | 19 | |
| Treatment Period 3 (Days 21 to 26) | NOT COMPLETED | All Treated Participants | 0 |
Source ClinicalTrials.gov
Adverse events36
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 | Dizziness | Nervous system disorders | Treatment A: Probe Substrates | 0 | 20 | |
| other | Dizziness | Nervous system disorders | Treatment B: GSK3640254 200 mg | 3 | 20 | |
| other | Dizziness | Nervous system disorders | Treatment C: Probe Substrates + GSK3640254 200 mg | 0 | 19 | |
| other | Headache | Nervous system disorders | Treatment A: Probe Substrates | 1 | 20 | |
| other | Headache | Nervous system disorders | Treatment B: GSK3640254 200 mg | 1 | 20 | |
| other | Headache | Nervous system disorders | Treatment C: Probe Substrates + GSK3640254 200 mg | 1 | 19 | |
| other | Taste disorder | Nervous system disorders | Treatment A: Probe Substrates | 0 | 20 | |
| other | Taste disorder | Nervous system disorders | Treatment B: GSK3640254 200 mg | 0 | 20 | |
| other | Taste disorder | Nervous system disorders | Treatment C: Probe Substrates + GSK3640254 200 mg | 1 | 19 | |
| other | Nausea | Gastrointestinal disorders | Treatment A: Probe Substrates | 0 | 20 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment A: Probe Substrates | 0 | 20 |
| Total, all-cause mortality | Treatment B: GSK3640254 200 mg | 0 | 20 |
| Total, all-cause mortality | Treatment C: Probe Substrates + GSK3640254 200 mg | 0 | 19 |
| Total, other adverse events | Treatment A: Probe Substrates | 1 | 20 |
| Total, other adverse events | Treatment B: GSK3640254 200 mg | 5 | 20 |
| Total, other adverse events | Treatment C: Probe Substrates + GSK3640254 200 mg | 5 | 19 |
| Total, serious adverse events | Treatment A: Probe Substrates | 0 | 20 |
| Total, serious adverse events | Treatment B: GSK3640254 200 mg | 0 | 20 |
| Total, serious adverse events | Treatment C: Probe Substrates + GSK3640254 200 mg | 0 | 19 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36822839 | BACKGROUND |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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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