Trial · NCT05959447
Evaluation of the Potential Drug-drug Interactions Between Gemfibrozil or Dabigatran Etexilate and Camlipixant
NCT05959447, Phase 1, Completed, Bellus Health Inc. - a GSK company; results first posted 2025-03-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of the Potential Drug-drug Interactions Between Gemfibrozil or Dabigatran Etexilate and Camlipixant. Trials, record NCT05959447. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05959447
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of the Potential Drug-drug Interactions Between Gemfibrozil or Dabigatran Etexilate and Camlipixant
- NCT number
- NCT05959447
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 45 participants, actual
- Lead sponsor
- Bellus Health Inc. - a GSK company
- Conditions
- Cough, Healthy
- Interventions
- Camlipixant, Dabigatran etexilate, Gemfibrozil
- First posted
- 2023-07-25
- Last updated
- 2025-03-26
- Results first posted
- 2025-03-26
Source ClinicalTrials.gov
Registered outcomes45
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC-inf) of Camlipixant | Pre-dose, 0.25 , 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 48, 72 hours post-dose on Day 1 and Day 9 | Blood samples were collected at indicated time points for PK analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods. |
| Primary | Part 1: Area Under the Concentration-time Curve From Time Zero Until the Last Observed Concentration (AUC[0-t]) of Camlipixant | Pre-dose, 0.25 , 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 48, 72 hours post-dose on Day 1 and Day 9 | Blood samples were collected at indicated time points for PK analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods. |
| Primary | Part 1: Maximal Observed Concentration (Cmax) of Camlipixant | Pre-dose, 0.25 , 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 48, 72 hours post-dose on Day 1 and Day 9 | Blood samples were collected at indicated time points for PK analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods. |
| Primary | Part 2: AUC(0-Infinity) of Free Dabigatran | Pre-dose, 0.25 , 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72 hours post-dose on Day 1 and Day 10 | Blood samples were collected at indicated time points for PK analysis of Dabigatran. PK analysis was conducted using standard non-compartmental methods. |
| Primary | Part 2: AUC(0-t) of Free Dabigatran | Pre-dose, 0.25 , 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72 hours post-dose on Day 1 and Day 10 | Blood samples were collected at indicated time points for PK analysis of Dabigatran. PK analysis was conducted using standard non-compartmental methods. |
| Primary | Part 2: Cmax of Free Dabigatran | Pre-dose, 0.25 , 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72 hours post-dose on Day 1 and Day 10 | Blood samples were collected at indicated time points for PK analysis of Dabigatran. PK analysis was conducted using standard non-compartmental methods. |
| Primary | Part 2: AUC(0-Infinity) of Total Dabigatran | Pre-dose, 0.25 , 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72 hours post-dose on Day 1 and Day 10 | Blood samples were collected at indicated time points for PK analysis of Dabigatran. PK analysis was conducted using standard non-compartmental methods. |
| Primary | Part 2: AUC(0-t) of Total Dabigatran | Pre-dose, 0.25 , 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72 hours post-dose on Day 1 and Day 10 | Blood samples were collected at indicated time points for PK analysis of Dabigatran. PK analysis was conducted using standard non-compartmental methods. |
| Primary | Part 2: Cmax of Total Dabigatran | Pre-dose, 0.25 , 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72 hours post-dose on Day 1 and Day 10 | Blood samples were collected at indicated time points for PK analysis of Dabigatran. PK analysis was conducted using standard non-compartmental methods. |
| Secondary | Part 1: Time to Reach Maximum Observed Concentration (Tmax) of Camlipixant | Pre-dose, 0.25 , 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 48, 72 hours post-dose on Day 1 and Day 9 | Blood samples were collected at indicated time points for PK analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods. |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 registered outcomesOutcomes45
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC-inf) of Camlipixant | Pre-dose, 0.25 , 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 48, 72 hours post-dose on Day 1 and Day 9 | The PK parameter Population included all participants for whom the Day 1 and Day 9 PK profiles of the camlipixant could be adequately characterized, specifically, when administered alone and in combination with gemfibrozil (Part 1) | Hours*nanograms per milliliter | GEOMETRIC_MEAN |
| PRIMARY | Part 1: Area Under the Concentration-time Curve From Time Zero Until the Last Observed Concentration (AUC[0-t]) of Camlipixant | Pre-dose, 0.25 , 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 48, 72 hours post-dose on Day 1 and Day 9 | The PK parameter Population included all participants for whom the Day 1 and Day 9 PK profiles of the camlipixant could be adequately characterized, specifically, when administered alone and in combination with gemfibrozil (Part 1) | Hours*nanograms per milliliter | GEOMETRIC_MEAN |
| PRIMARY | Part 1: Maximal Observed Concentration (Cmax) of Camlipixant | Pre-dose, 0.25 , 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 48, 72 hours post-dose on Day 1 and Day 9 | The PK parameter Population included all participants for whom the Day 1 and Day 9 PK profiles of the camlipixant could be adequately characterized, specifically, when administered alone and in combination with gemfibrozil (Part 1) | Nanograms per milliliter | GEOMETRIC_MEAN |
| PRIMARY | Part 2: AUC(0-Infinity) of Free Dabigatran | Pre-dose, 0.25 , 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72 hours post-dose on Day 1 and Day 10 | The PK parameter Population included all participants for whom the Day 1 and Day 10 PK profiles of the dabigatran could be adequately characterized, specifically, when administered alone and in combination with camlipixant (Part 2). Only those participants who were measured and analyzed (i.e., contributed data reported in table) were included in 'Overall Number of Participants Analyzed' field. | Hours*nanograms per milliliter | GEOMETRIC_MEAN |
| PRIMARY | Part 2: AUC(0-t) of Free Dabigatran | Pre-dose, 0.25 , 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72 hours post-dose on Day 1 and Day 10 | The PK parameter Population included all participants for whom the Day 1 and Day 10 PK profiles of the dabigatran could be adequately characterized, specifically, when administered alone and in combination with camlipixant (Part 2). Only those participants who were measured and analyzed (i.e., contributed data reported in table) were included in 'Overall Number of Participants Analyzed' field. | Hours*nanograms per milliliter | GEOMETRIC_MEAN |
| PRIMARY | Part 2: Cmax of Free Dabigatran | Pre-dose, 0.25 , 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72 hours post-dose on Day 1 and Day 10 | The PK parameter Population included all participants for whom the Day 1 and Day 10 PK profiles of the dabigatran could be adequately characterized, specifically, when administered alone and in combination with camlipixant (Part 2). Only those participants who were measured and analyzed (i.e., contributed data reported in table) were included in 'Overall Number of Participants Analyzed' field. | Nanograms per milliliter | GEOMETRIC_MEAN |
| PRIMARY | Part 2: AUC(0-Infinity) of Total Dabigatran | Pre-dose, 0.25 , 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72 hours post-dose on Day 1 and Day 10 | The PK parameter Population included all participants for whom the Day 1 and Day 10 PK profiles of the dabigatran could be adequately characterized, specifically, when administered alone and in combination with camlipixant (Part 2). Only those participants who were measured and analyzed (i.e., contributed data reported in table) were included in 'Overall Number of Participants Analyzed' field. | Hours*nanograms per milliliter | GEOMETRIC_MEAN |
| PRIMARY | Part 2: AUC(0-t) of Total Dabigatran | Pre-dose, 0.25 , 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72 hours post-dose on Day 1 and Day 10 | The PK parameter Population included all participants for whom the Day 1 and Day 10 PK profiles of the dabigatran could be adequately characterized, specifically, when administered alone and in combination with camlipixant (Part 2). Only those participants who were measured and analyzed (i.e., contributed data reported in table) were included in 'Overall Number of Participants Analyzed' field. | Hours*nanograms per milliliter | GEOMETRIC_MEAN |
| PRIMARY | Part 2: Cmax of Total Dabigatran | Pre-dose, 0.25 , 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72 hours post-dose on Day 1 and Day 10 | The PK parameter Population included all participants for whom the Day 1 and Day 10 PK profiles of the dabigatran could be adequately characterized, specifically, when administered alone and in combination with camlipixant (Part 2). Only those participants who were measured and analyzed (i.e., contributed data reported in table) were included in 'Overall Number of Participants Analyzed' field. | Nanograms per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Part 1: Time to Reach Maximum Observed Concentration (Tmax) of Camlipixant | Pre-dose, 0.25 , 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 48, 72 hours post-dose on Day 1 and Day 9 | The PK parameter Population included all participants for whom the Day 1 and Day 9 PK profiles of the camlipixant could be adequately characterized, specifically, when administered alone and in combination with gemfibrozil (Part 1) | Hours | MEDIAN |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 outcomesResults by group95
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part 1: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC-inf) of Camlipixant | Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg | Day 1 | 4886.66 | Geometric Coefficient of Variation 28.69 | Hours*nanograms per milliliter |
| Part 1: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC-inf) of Camlipixant | Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg | Day 9 | 10642.07 | Geometric Coefficient of Variation 24.17 | Hours*nanograms per milliliter |
| Part 1: Area Under the Concentration-time Curve From Time Zero Until the Last Observed Concentration (AUC[0-t]) of Camlipixant | Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg | Day 1 | 4846.83 | Geometric Coefficient of Variation 28.84 | Hours*nanograms per milliliter |
| Part 1: Area Under the Concentration-time Curve From Time Zero Until the Last Observed Concentration (AUC[0-t]) of Camlipixant | Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg | Day 9 | 10541.57 | Geometric Coefficient of Variation 24.44 | Hours*nanograms per milliliter |
| Part 1: Maximal Observed Concentration (Cmax) of Camlipixant | Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg | Day 1 | 1078 | Geometric Coefficient of Variation 25.02 | Nanograms per milliliter |
| Part 1: Maximal Observed Concentration (Cmax) of Camlipixant | Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg | Day 9 | 1303 | Geometric Coefficient of Variation 25.65 | Nanograms per milliliter |
| Part 2: AUC(0-Infinity) of Free Dabigatran | Part 2: Dabigatran Etexilate 150 mg + Camlipixant 50 mg | Day 1 | 943.49 | Geometric Coefficient of Variation 52.12 | Hours*nanograms per milliliter |
| Part 2: AUC(0-Infinity) of Free Dabigatran | Part 2: Dabigatran Etexilate 150 mg + Camlipixant 50 mg | Day 10 | 1055.20 | Geometric Coefficient of Variation 43.81 | Hours*nanograms per milliliter |
| Part 2: AUC(0-t) of Free Dabigatran | Part 2: Dabigatran Etexilate 150 mg + Camlipixant 50 mg | Day 1 | 920.18 | Geometric Coefficient of Variation 53.11 | Hours*nanograms per milliliter |
| Part 2: AUC(0-t) of Free Dabigatran | Part 2: Dabigatran Etexilate 150 mg + Camlipixant 50 mg | Day 10 | 1031.89 | Geometric Coefficient of Variation 45.03 | Hours*nanograms per milliliter |
1 to 10 of 95Source ClinicalTrials.gov
See all 95 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1 (Up to Day 21) | STARTED | Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg | 25 | |
| Part 1 (Up to Day 21) | STARTED | Part 2: Dabigatran Etexilate 150 mg + Camlipixant 50 mg | 0 | |
| Part 1 (Up to Day 21) | Safety Population | Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg | 16 | |
| Part 1 (Up to Day 21) | Safety Population | Part 2: Dabigatran Etexilate 150 mg + Camlipixant 50 mg | 0 | |
| Part 1 (Up to Day 21) | COMPLETED | Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg | 15 | |
| Part 1 (Up to Day 21) | COMPLETED | Part 2: Dabigatran Etexilate 150 mg + Camlipixant 50 mg | 0 | |
| Part 1 (Up to Day 21) | NOT COMPLETED | Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg | 10 | |
| Part 1 (Up to Day 21) | NOT COMPLETED | Part 2: Dabigatran Etexilate 150 mg + Camlipixant 50 mg | 0 | |
| Part 2 (Up to Day 22) | STARTED | Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg | 0 | |
| Part 2 (Up to Day 22) | STARTED | Part 2: Dabigatran Etexilate 150 mg + Camlipixant 50 mg | 20 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events192
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 | Palpitations | Cardiac disorders | Part 1: Camlipixant 50 mg | 0 | 16 | |
| other | Palpitations | Cardiac disorders | Part 1: Gemfibrozil 600 mg | 0 | 16 | |
| other | Palpitations | Cardiac disorders | Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg | 1 | 16 | |
| other | Palpitations | Cardiac disorders | Part 2: Dabigatran Etexilate 150 mg | 0 | 16 | |
| other | Palpitations | Cardiac disorders | Part 2: Camlipixant 50 mg | 0 | 15 | |
| other | Palpitations | Cardiac disorders | Part 2: Dabigatran Etexilate 150 mg+ Camlipixant 50 mg | 0 | 14 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Part 1: Camlipixant 50 mg | 0 | 16 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Part 1: Gemfibrozil 600 mg | 0 | 16 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg | 1 | 16 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Part 2: Dabigatran Etexilate 150 mg | 0 | 16 |
1 to 10 of 192Source ClinicalTrials.gov
See all 192 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1: Camlipixant 50 mg | 0 | 16 |
| Total, all-cause mortality | Part 1: Gemfibrozil 600 mg | 0 | 16 |
| Total, all-cause mortality | Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg | 0 | 16 |
| Total, all-cause mortality | Part 2: Dabigatran Etexilate 150 mg | 0 | 16 |
| Total, all-cause mortality | Part 2: Camlipixant 50 mg | 0 | 15 |
| Total, all-cause mortality | Part 2: Dabigatran Etexilate 150 mg+ Camlipixant 50 mg | 0 | 14 |
| Total, other adverse events | Part 1: Camlipixant 50 mg | 1 | 16 |
| Total, other adverse events | Part 1: Gemfibrozil 600 mg | 6 | 16 |
| Total, other adverse events | Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg | 5 | 16 |
| Total, other adverse events | Part 2: Dabigatran Etexilate 150 mg | 4 | 16 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 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 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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