Trial Outcomes & Findings for Evaluation of the Potential Drug-drug Interactions Between Gemfibrozil or Dabigatran Etexilate and Camlipixant (NCT NCT05959447)
NCT ID: NCT05959447
Last Updated: 2025-03-26
Results Overview
Blood samples were collected at indicated time points for PK analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods.
COMPLETED
PHASE1
45 participants
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
2025-03-26
Participant Flow
A total of 45 participants were enrolled in the study (25 participants in Part 1 and 20 participants in Part 2). Only 32 participants (13 participants were never dosed) were dosed into the study to receive either camlipixant + gemfibrozil or dabigatran etexilate+ camlipixant creating the Safety Population. (The safety population included all participants who received at least one dose of any study drug).
Participant milestones
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 2: Dabigatran Etexilate 150 mg + Camlipixant 50 mg
Participants received single oral dose of dabigatran etexilate 150 mg capsule on Day 1, followed by repeated oral doses of camlipixant 50 mg tablet twice daily (BID) (total daily dose of 100 mg) from Days 5 to 9, with co-administration of a single oral dose of dabigatran etexilate 150 mg capsule with the morning dose of camlipixant on Day 10. There was a washout of at least 4 days between the dose of dabigatran etexilate on Day 1 and the dose of camlipixant on Day 5.
|
|---|---|---|
|
Part 1 (Up to Day 21)
STARTED
|
25
|
0
|
|
Part 1 (Up to Day 21)
Safety Population
|
16
|
0
|
|
Part 1 (Up to Day 21)
COMPLETED
|
15
|
0
|
|
Part 1 (Up to Day 21)
NOT COMPLETED
|
10
|
0
|
|
Part 2 (Up to Day 22)
STARTED
|
0
|
20
|
|
Part 2 (Up to Day 22)
Safety Population
|
0
|
16
|
|
Part 2 (Up to Day 22)
COMPLETED
|
0
|
14
|
|
Part 2 (Up to Day 22)
NOT COMPLETED
|
0
|
6
|
Reasons for withdrawal
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 2: Dabigatran Etexilate 150 mg + Camlipixant 50 mg
Participants received single oral dose of dabigatran etexilate 150 mg capsule on Day 1, followed by repeated oral doses of camlipixant 50 mg tablet twice daily (BID) (total daily dose of 100 mg) from Days 5 to 9, with co-administration of a single oral dose of dabigatran etexilate 150 mg capsule with the morning dose of camlipixant on Day 10. There was a washout of at least 4 days between the dose of dabigatran etexilate on Day 1 and the dose of camlipixant on Day 5.
|
|---|---|---|
|
Part 1 (Up to Day 21)
Adverse Event
|
1
|
0
|
|
Part 1 (Up to Day 21)
Enrolled but did not receive study treatment
|
9
|
0
|
|
Part 2 (Up to Day 22)
Adverse Event
|
0
|
2
|
|
Part 2 (Up to Day 22)
Enrolled but did not receive study treatment
|
0
|
4
|
Baseline Characteristics
Evaluation of the Potential Drug-drug Interactions Between Gemfibrozil or Dabigatran Etexilate and Camlipixant
Baseline characteristics by cohort
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=16 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 2: Dabigatran Etexilate 150 mg + Camlipixant 50 mg
n=16 Participants
Participants received single oral dose of dabigatran etexilate 150 mg capsule on Day 1, followed by repeated oral doses of camlipixant 50 mg tablet twice daily (BID) (total daily dose of 100 mg) from Days 5 to 9, with co-administration of a single oral dose of dabigatran etexilate 150 mg capsule with the morning dose of camlipixant on Day 10. There was a washout of at least 4 days between the dose of dabigatran etexilate on Day 1 and the dose of camlipixant on Day 5.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
23 to 54 years
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
All Other Races
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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 9Population: 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)
Blood samples were collected at indicated time points for PK analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=16 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 1: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC-inf) of Camlipixant
Day 1
|
4886.66 Hours*nanograms per milliliter
Geometric Coefficient of Variation 28.69
|
—
|
—
|
|
Part 1: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC-inf) of Camlipixant
Day 9
|
10642.07 Hours*nanograms per milliliter
Geometric Coefficient of Variation 24.17
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 9Population: 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)
Blood samples were collected at indicated time points for PK analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=16 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 1: Area Under the Concentration-time Curve From Time Zero Until the Last Observed Concentration (AUC[0-t]) of Camlipixant
Day 1
|
4846.83 Hours*nanograms per milliliter
Geometric Coefficient of Variation 28.84
|
—
|
—
|
|
Part 1: Area Under the Concentration-time Curve From Time Zero Until the Last Observed Concentration (AUC[0-t]) of Camlipixant
Day 9
|
10541.57 Hours*nanograms per milliliter
Geometric Coefficient of Variation 24.44
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 9Population: 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)
Blood samples were collected at indicated time points for PK analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=16 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 1: Maximal Observed Concentration (Cmax) of Camlipixant
Day 1
|
1078 Nanograms per milliliter
Geometric Coefficient of Variation 25.02
|
—
|
—
|
|
Part 1: Maximal Observed Concentration (Cmax) of Camlipixant
Day 9
|
1303 Nanograms per milliliter
Geometric Coefficient of Variation 25.65
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 10Population: 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.
Blood samples were collected at indicated time points for PK analysis of Dabigatran. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=14 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 2: AUC(0-Infinity) of Free Dabigatran
Day 1
|
943.49 Hours*nanograms per milliliter
Geometric Coefficient of Variation 52.12
|
—
|
—
|
|
Part 2: AUC(0-Infinity) of Free Dabigatran
Day 10
|
1055.20 Hours*nanograms per milliliter
Geometric Coefficient of Variation 43.81
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 10Population: 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.
Blood samples were collected at indicated time points for PK analysis of Dabigatran. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=14 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 2: AUC(0-t) of Free Dabigatran
Day 1
|
920.18 Hours*nanograms per milliliter
Geometric Coefficient of Variation 53.11
|
—
|
—
|
|
Part 2: AUC(0-t) of Free Dabigatran
Day 10
|
1031.89 Hours*nanograms per milliliter
Geometric Coefficient of Variation 45.03
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 10Population: 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.
Blood samples were collected at indicated time points for PK analysis of Dabigatran. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=14 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 2: Cmax of Free Dabigatran
Day 1
|
110 Nanograms per milliliter
Geometric Coefficient of Variation 53.53
|
—
|
—
|
|
Part 2: Cmax of Free Dabigatran
Day 10
|
125 Nanograms per milliliter
Geometric Coefficient of Variation 47.75
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 10Population: 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.
Blood samples were collected at indicated time points for PK analysis of Dabigatran. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=14 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 2: AUC(0-Infinity) of Total Dabigatran
Day 1
|
1165.82 Hours*nanograms per milliliter
Geometric Coefficient of Variation 52.34
|
—
|
—
|
|
Part 2: AUC(0-Infinity) of Total Dabigatran
Day 10
|
1339.35 Hours*nanograms per milliliter
Geometric Coefficient of Variation 41.21
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 10Population: 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.
Blood samples were collected at indicated time points for PK analysis of Dabigatran. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=14 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 2: AUC(0-t) of Total Dabigatran
Day 1
|
1139.80 Hours*nanograms per milliliter
Geometric Coefficient of Variation 53.51
|
—
|
—
|
|
Part 2: AUC(0-t) of Total Dabigatran
Day 10
|
1316.80 Hours*nanograms per milliliter
Geometric Coefficient of Variation 41.83
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 10Population: 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.
Blood samples were collected at indicated time points for PK analysis of Dabigatran. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=14 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 2: Cmax of Total Dabigatran
Day 1
|
135 Nanograms per milliliter
Geometric Coefficient of Variation 54.20
|
—
|
—
|
|
Part 2: Cmax of Total Dabigatran
Day 10
|
160 Nanograms per milliliter
Geometric Coefficient of Variation 42.42
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 9Population: 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)
Blood samples were collected at indicated time points for PK analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=16 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 1: Time to Reach Maximum Observed Concentration (Tmax) of Camlipixant
Day 1
|
0.750 Hours
Interval 0.5 to 2.0
|
—
|
—
|
|
Part 1: Time to Reach Maximum Observed Concentration (Tmax) of Camlipixant
Day 9
|
0.750 Hours
Interval 0.5 to 2.5
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 9Population: 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)
Blood samples were collected at indicated time points for PK analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=16 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 1: Terminal Elimination Half-Life (T1/2) Following Administration of Camlipixant
Day 1
|
5.56 Hours
Geometric Coefficient of Variation 31.80
|
—
|
—
|
|
Part 1: Terminal Elimination Half-Life (T1/2) Following Administration of Camlipixant
Day 9
|
9.56 Hours
Geometric Coefficient of Variation 18.60
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 9Population: 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)
Blood samples were collected at indicated time points for PK analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods. Percentage of AUC extrapolation was calculated as \[1 - (AUC0-t/AUC0-inf)\] \* 100.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=16 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 1: Percentage of AUC0-Infinity Due to Extrapolation From the Time of the Last Observed Concentration to Infinity (%AUC Extrapolation) of Camlipixant
Day 1
|
0.58 Percentage of AUC extrapolation
Geometric Coefficient of Variation 104.04
|
—
|
—
|
|
Part 1: Percentage of AUC0-Infinity Due to Extrapolation From the Time of the Last Observed Concentration to Infinity (%AUC Extrapolation) of Camlipixant
Day 9
|
0.59 Percentage of AUC extrapolation
Geometric Coefficient of Variation 109.24
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 9Population: 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)
Blood samples were collected at indicated time points for PK analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=16 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 1: Terminal Elimination Rate Constant of Camlipixant (Kel)
Day 1
|
0.1247 h^-1
Geometric Coefficient of Variation 31.80
|
—
|
—
|
|
Part 1: Terminal Elimination Rate Constant of Camlipixant (Kel)
Day 9
|
0.0725 h^-1
Geometric Coefficient of Variation 18.60
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 9Population: 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)
Blood samples were collected at indicated time points for PK analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=16 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 1: Apparent Clearance (CL/F) of Camlipixant
Day 1
|
10.23 Liters per hour
Geometric Coefficient of Variation 28.69
|
—
|
—
|
|
Part 1: Apparent Clearance (CL/F) of Camlipixant
Day 9
|
4.70 Liters per hour
Geometric Coefficient of Variation 24.17
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 9Population: 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)
Blood samples were collected at indicated time points for PK analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=16 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 1: Apparent Volume of Distribution (Vz/F) of Camlipixant
Day 1
|
82.06 Liters
Geometric Coefficient of Variation 22.57
|
—
|
—
|
|
Part 1: Apparent Volume of Distribution (Vz/F) of Camlipixant
Day 9
|
64.80 Liters
Geometric Coefficient of Variation 23.69
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 10Population: 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.
Blood samples were collected at indicated time points for PK analysis of Dabigatran. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=14 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 2: Tmax of Free Dabigatran
Day 1
|
2.000 Hours
Interval 1.5 to 3.5
|
—
|
—
|
|
Part 2: Tmax of Free Dabigatran
Day 10
|
2.000 Hours
Interval 1.5 to 3.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 10Population: 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.
Blood samples were collected at indicated time points for PK analysis of Dabigatran. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=14 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 2: T1/2 Following Administration Free Dabigatran
Day 1
|
10.49 Hours
Geometric Coefficient of Variation 18.23
|
—
|
—
|
|
Part 2: T1/2 Following Administration Free Dabigatran
Day 10
|
9.18 Hours
Geometric Coefficient of Variation 9.16
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 10Population: 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.
Blood samples were collected at indicated time points for PK analysis of Dabigatran. PK analysis was conducted using standard non-compartmental methods. Percentage of AUC extrapolation was calculated as \[1 - (AUC0-t/AUC0-inf)\] \* 100.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=14 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 2: Percentage of AUC0-Infinity Due to Extrapolation From the Time of the Last Observed Concentration to Infinity (%AUC Extrapolation) of Free Dabigatran
Day 1
|
2.22 Percentage of AUC extrapolation
Geometric Coefficient of Variation 49.87
|
—
|
—
|
|
Part 2: Percentage of AUC0-Infinity Due to Extrapolation From the Time of the Last Observed Concentration to Infinity (%AUC Extrapolation) of Free Dabigatran
Day 10
|
1.95 Percentage of AUC extrapolation
Geometric Coefficient of Variation 52.63
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 10Population: 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.
Blood samples were collected at indicated time points for PK analysis of Dabigatran. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=14 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 2: Kel Free Dabigatran
Day 1
|
0.0660 h^-1
Geometric Coefficient of Variation 18.23
|
—
|
—
|
|
Part 2: Kel Free Dabigatran
Day 10
|
0.0755 h^-1
Geometric Coefficient of Variation 9.16
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 10Population: 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.
Blood samples were collected at indicated time points for PK analysis of Dabigatran. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=14 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 2: CL/F Free Dabigatran
Day 1
|
158.98 Liters per hour
Geometric Coefficient of Variation 52.12
|
—
|
—
|
|
Part 2: CL/F Free Dabigatran
Day 10
|
142.15 Liters per hour
Geometric Coefficient of Variation 43.81
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 10Population: 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.
Blood samples were collected at indicated time points for PK analysis of Dabigatran. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=14 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 2: Vz/F Free Dabigatran
Day 1
|
2407.03 Liters
Geometric Coefficient of Variation 54.73
|
—
|
—
|
|
Part 2: Vz/F Free Dabigatran
Day 10
|
1883.56 Liters
Geometric Coefficient of Variation 43.72
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 10Population: 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.
Blood samples were collected at indicated time points for PK analysis of Dabigatran. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=14 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 2: Tmax of Total Dabigatran
Day 1
|
2.000 Hours
Interval 1.0 to 3.5
|
—
|
—
|
|
Part 2: Tmax of Total Dabigatran
Day 10
|
2.000 Hours
Interval 1.0 to 3.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 10Population: 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.
Blood samples were collected at indicated time points for PK analysis of Dabigatran. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=14 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 2: T1/2 Following Administration of Total Dabigatran
Day 1
|
11.04 Hours
Geometric Coefficient of Variation 30.01
|
—
|
—
|
|
Part 2: T1/2 Following Administration of Total Dabigatran
Day 10
|
10.21 Hours
Geometric Coefficient of Variation 16.90
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 10Population: 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.
Blood samples were collected at indicated time points for PK analysis of Dabigatran. PK analysis was conducted using standard non-compartmental methods. Percentage of AUC extrapolation was calculated as \[1 - (AUC0-t/AUC0-inf)\] \* 100.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=14 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 2: Percentage of AUC0-Infinity Due to Extrapolation From the Time of the Last Observed Concentration to Infinity (%AUC Extrapolation) of Total Dabigatran
Day 1
|
1.93 Percentage of AUC extrapolation
Geometric Coefficient of Variation 59.97
|
—
|
—
|
|
Part 2: Percentage of AUC0-Infinity Due to Extrapolation From the Time of the Last Observed Concentration to Infinity (%AUC Extrapolation) of Total Dabigatran
Day 10
|
1.58 Percentage of AUC extrapolation
Geometric Coefficient of Variation 37.14
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 10Population: 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.
Blood samples were collected at indicated time points for PK analysis of Dabigatran. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=14 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 2: Kel of Total Dabigatran
Day 1
|
0.0628 h^-1
Geometric Coefficient of Variation 30.01
|
—
|
—
|
|
Part 2: Kel of Total Dabigatran
Day 10
|
0.0679 h^-1
Geometric Coefficient of Variation 16.90
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 10Population: 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.
Blood samples were collected at indicated time points for PK analysis of Dabigatran. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=14 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 2: CL/F of Total Dabigatran
Day 1
|
128.66 Liters per hour
Geometric Coefficient of Variation 52.34
|
—
|
—
|
|
Part 2: CL/F of Total Dabigatran
Day 10
|
111.99 Liters per hour
Geometric Coefficient of Variation 41.21
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 10Population: 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.
Blood samples were collected at indicated time points for PK analysis of Dabigatran. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=14 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 2: Vz/F of Total Dabigatran
Day 1
|
2048.49 Liters
Geometric Coefficient of Variation 61.16
|
—
|
—
|
|
Part 2: Vz/F of Total Dabigatran
Day 10
|
1649.21 Liters
Geometric Coefficient of Variation 37.35
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 post-dose until Day 5 pre-dose of gemfibrozil [camlipixant 50mg]; from Day 5 dosing until Day 9 pre-dose of camlipixant [gemfibrozil 600mg]; from camlipixant dosing on Day 9 until end of study [Day 21] [camlipixant 50mg+gemfibrozil 600mg]Population: Safety Population consisted of all participants who received at least one dose of any study drug.
An adverse event (AE) is defined as any untoward medical occurrence in a participant who is administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. Serious adverse events (SAEs) are defined as any untoward medical occurrence that; at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, other situations as per medical and scientific judgement. Adverse events of medical interest (AEMIs) are AEs of scientific interest specific to the drug class. AEMIs for this study includes the following, but not limited to taste disturbances (dysgeusia, hypogeusia, ageusia), oral paresthesia and oral hypoesthesia Treatment-emergent events (i.e., TEAEs, TESAEs and TEAEMIs) were defined as events that commence on or after the time of first study drug administration
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=16 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
n=16 Participants
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
n=16 Participants
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs) and Treatment-emergent Adverse Events of Medical Interest (TEAEMIs)
TEAEs
|
1 Participants
|
6 Participants
|
5 Participants
|
|
Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs) and Treatment-emergent Adverse Events of Medical Interest (TEAEMIs)
TESAEs
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs) and Treatment-emergent Adverse Events of Medical Interest (TEAEMIs)
TEAEMIs
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day1 postdose until Day5 predose of camlipixant [dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran [camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day 22][dabigatran etexilate 150mg+camlipixant 50mg]Population: Safety population consisted of all participants who received at least one dose of any study drug.
An adverse event (AE) is defined as any untoward medical occurrence in a participant who is administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. Serious adverse events (SAEs) are defined as any untoward medical occurrence that; at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, other situations as per medical and scientific judgement. Adverse events of medical interest (AEMIs) are AEs of scientific interest specific to the drug class. AEMIs for this study includes the following, but not limited to: taste disturbances (dysgeusia, hypogeusia, ageusia), oral paresthesia and oral hypoesthesia Treatment-emergent events (i.e., TEAEs, TESAEs and TEAEMIs) were defined as events that commence on or after the time of first study drug administration.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=16 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
n=15 Participants
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
n=14 Participants
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 2: Number of Participants With TEAEs, TESAEs and TEAEMIs
TEAEs
|
4 Participants
|
6 Participants
|
0 Participants
|
|
Part 2: Number of Participants With TEAEs, TESAEs and TEAEMIs
TESAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With TEAEs, TESAEs and TEAEMIs
TEAEMIs
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 5, Day 9 pre-dose and 1 hour post-dose, Day 12Population: Safety population consisted of all participants who received at least one dose of any study drug.
A 12-lead ECG was recorded with the participant in a semi-recumbent or supine position, after 5 minutes of rest using an ECG machine. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for the number of participants with abnormal clinically significant 12-Lead ECG findings have been presented.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=16 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 1: Number of Participants With Abnormal Clinically Significant Changes in 12-Lead Electrocardiogram (ECG) Findings
Day 5
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Abnormal Clinically Significant Changes in 12-Lead Electrocardiogram (ECG) Findings
Day 9,1-Hour Post-dose
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Abnormal Clinically Significant Changes in 12-Lead Electrocardiogram (ECG) Findings
Day 9, Pre-dose
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Abnormal Clinically Significant Changes in 12-Lead Electrocardiogram (ECG) Findings
Day 12
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 5, Day 10 and Day 13Population: Safety population consisted of all participants who received at least one dose of any study drug.
A 12-lead ECG was recorded with the participant in a semi-recumbent or supine position, after 5 minutes of rest using an ECG machine. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for the number of participants with abnormal clinically significant 12-Lead ECG findings have been presented.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=16 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 2: Number of Participants With Abnormal Clinically Significant Changes in 12-Lead ECG Findings
Day 13
|
0 Participants
|
—
|
—
|
|
Part 2: Number of Participants With Abnormal Clinically Significant Changes in 12-Lead ECG Findings
Day 5
|
0 Participants
|
—
|
—
|
|
Part 2: Number of Participants With Abnormal Clinically Significant Changes in 12-Lead ECG Findings
Day 10
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 9 and Day 12Population: Safety population consisted of all participants who received at least one dose of any study drug.
Vital signs including DBP, SBP, and heart rate were measured in a sitting position after resting for at least 5 minutes. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for the number of participants with abnormal clinically significant changes for vital signs have been presented.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=16 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 1: Number of Participants With Abnormal Clinically Significant Changes in Vital Signs: Diastolic Blood Pressure (DBP), Systolic Blood Pressure (SBP), and Heart Rate
Day 9
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Abnormal Clinically Significant Changes in Vital Signs: Diastolic Blood Pressure (DBP), Systolic Blood Pressure (SBP), and Heart Rate
Day 12
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 10 and Day 13Population: Safety population consisted of all participants who received at least one dose of any study drug.
Vital signs including DBP, SBP, and heart rate were measured in a sitting position after resting for at least 5 minutes. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for the number of participants with abnormal clinically significant changes for vital signs have been presented.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=16 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 2: Number of Participants With Abnormal Clinically Significant Changes in Vital Signs: DBP, SBP, and Heart Rate
Day 13
|
0 Participants
|
—
|
—
|
|
Part 2: Number of Participants With Abnormal Clinically Significant Changes in Vital Signs: DBP, SBP, and Heart Rate
Day 10
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 12Population: Safety population consisted of all participants who received at least one dose of any study drug.
Vital signs including respiratory rate and oral temperature were measured after resting for at least 5 minutes in a sitting position. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for the number of participants with abnormal clinically significant changes for vital signs have been presented.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=16 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 1: Number of Participants With Abnormal Clinically Significant Changes in Vital Signs: Respiratory Rate and Oral Temperature
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 13Population: Safety population consisted of all participants who received at least one dose of any study drug.
Vital signs including respiratory rate and oral temperature were measured after resting for at least 5 minutes in a sitting position. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for the number of participants with abnormal clinically significant changes for vital signs have been presented.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=16 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 2: Number of Participants With Abnormal Clinically Significant Changes in Vital Signs: Respiratory Rate and Oral Temperature
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 12Population: Safety population consisted of all participants who received at least one dose of any study drug.
Physical examination included assessment of the head, eyes, ears, nose, throat, neck, chest, lungs, abdomen, musculoskeletal, dermatological, cardiovascular/peripheral vascular, and general neurological examination. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for the number of participants with abnormal clinically significant changes in physical examination has been presented.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=16 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 1: Number of Participants With Abnormal Clinically Significant Changes During Physical Examination
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 13Population: Safety population consisted of all participants who received at least one dose of any study drug.
Physical examination included assessment of the head, eyes, ears, nose, throat, neck, chest, lungs, abdomen, musculoskeletal, dermatological, cardiovascular/peripheral vascular, and general neurological examination. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for the number of participants with abnormal clinically significant changes in physical examination has been presented.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=16 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 2: Number of Participants With Abnormal Clinically Significant Changes During Physical Examination
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 12Population: Safety population consisted of all participants who received at least one dose of any study drug.
Blood samples were collected to analyze hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Hematocrit, Hemoglobin, Platelets, and Erythrocytes. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Number of participants with abnormal clinically significant changes in hematology parameters were reported.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=16 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 1: Number of Participants With Abnormal Clinically Significant Changes in Hematology Parameters
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 13Population: Safety population consisted of all participants who received at least one dose of any study drug.
Blood samples were collected to analyze hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Hematocrit, Hemoglobin, Platelets, and Erythrocytes. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Number of participants with abnormal clinically significant changes in hematology parameters were reported.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=16 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 2: Number of Participants With Abnormal Clinically Significant Changes in Hematology Parameters
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 12Population: Safety population consisted of all participants who received at least one dose of any study drug.
Blood samples were collected to analyze clinical chemical parameters: albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, calcium, chloride, creatinine kinase, creatinine, gamma glutamyl transferase, glucose, phosphate, potassium, sodium, total, direct, and indirect bilirubin, protein, urea, and urate. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Number of Participants with abnormal clinically significant changes in clinical chemistry parameters were reported.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=16 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 1: Number of Participants With Abnormal Clinically Significant Changes in Clinical Chemistry Parameters
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 13Population: Safety population consisted of all participants who received at least one dose of any study drug.
Blood samples were collected to analyze clinical chemical parameters: albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, calcium, chloride, creatinine kinase, creatinine, gamma glutamyl transferase, glucose, phosphate, potassium, sodium, total, direct, and indirect bilirubin, protein, urea, and urate. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Number of Participants with abnormal clinically significant changes in clinical chemistry parameters were reported.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=16 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 2: Number of Participants With Abnormal Clinically Significant Changes in Clinical Chemistry Parameters
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 12Population: Safety population consisted of all participants who received at least one dose of any study drug.
Blood samples were collected to analyze coagulation parameters: activated partial thromboplastin time, prothrombin time international normalized ratio (INR), and prothrombin time. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Number of Participants with abnormal clinically significant changes in coagulation parameters were reported.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=16 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 1: Number of Participants With Abnormal Clinically Significant Changes in Coagulation Parameters
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 13Population: Safety population consisted of all participants who received at least one dose of any study drug.
Blood samples were collected to analyze coagulation parameters: activated partial thromboplastin time, prothrombin time international normalized ratio (INR), and prothrombin time. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Number of Participants with abnormal clinically significant changes in coagulation parameters were reported.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=16 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 2: Number of Participants With Abnormal Clinically Significant Changes in Coagulation Parameters
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 12Population: Safety population consisted of all participants who received at least one dose of any study drug.
Urine samples were collected to analyze urinalysis parameters: specific gravity and potential of hydrogen (pH). Bilirubin, blood (occult), glucose, ketones, leukocyte esterase, nitrite, protein, urobilinogen were analyzed by dipstick. The dipstick test gives results in a semi-quantitative manner, and results can be read as Negative, Trace, 1+, 2+ indicating proportional concentrations in the urine sample. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Number of Participants with abnormal clinically significant changes in urinalysis parameters were reported.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=16 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 1: Number of Participants With Abnormal Clinically Significant Changes in Urinalysis
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 13Population: Safety population consisted of all participants who received at least one dose of any study drug.
Urine samples were collected to analyze urinalysis parameters: specific gravity and potential of hydrogen (pH). Bilirubin, blood (occult), glucose, ketones, leukocyte esterase, nitrite, protein, urobilinogen were analyzed by dipstick. The dipstick test gives results in a semi-quantitative manner, and results can be read as Negative, Trace, 1+, 2+ indicating proportional concentrations in the urine sample. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Number of Participants with abnormal clinically significant changes in urinalysis parameters were reported.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg
n=16 Participants
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.
|
Part 1: Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
|---|---|---|---|
|
Part 2: Number of Participants With Abnormal Clinically Significant Changes in Urinalysis
|
0 Participants
|
—
|
—
|
Adverse Events
Part 1: Camlipixant 50 mg
Part 1: Gemfibrozil 600 mg
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
Part 2: Dabigatran Etexilate 150 mg
Part 2: Camlipixant 50 mg
Part 2: Dabigatran Etexilate 150 mg+ Camlipixant 50 mg
Serious adverse events
| Measure |
Part 1: Camlipixant 50 mg
n=16 participants at risk
Participants received a single oral dose of 50 mg camlipixant tablet on Day 1.
|
Part 1: Gemfibrozil 600 mg
n=16 participants at risk
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11.
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
n=16 participants at risk
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
Part 2: Dabigatran Etexilate 150 mg
n=16 participants at risk
Participants received single oral dose of dabigatran etexilate 150 mg capsule on Day 1
|
Part 2: Camlipixant 50 mg
n=15 participants at risk
Participants received repeated oral doses of camlipixant 50 mg tablet twice daily (BID) (total daily dose of 100 mg) from Days 5 to 10.
|
Part 2: Dabigatran Etexilate 150 mg+ Camlipixant 50 mg
n=14 participants at risk
Participants received repeated oral doses of camlipixant 50 mg tablet twice daily (BID) (total daily dose of 100 mg) from Days 5 to 9, with co-administration of a single oral dose of dabigatran etexilate 150 mg capsule with the morning dose of camlipixant on Day 10. Participants were followed up for adverse events until end of study (up to Day 22).
|
|---|---|---|---|---|---|---|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
6.2%
1/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/15 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/14 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
Other adverse events
| Measure |
Part 1: Camlipixant 50 mg
n=16 participants at risk
Participants received a single oral dose of 50 mg camlipixant tablet on Day 1.
|
Part 1: Gemfibrozil 600 mg
n=16 participants at risk
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11.
|
Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg
n=16 participants at risk
Participants received repeated oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. Participants were followed up for adverse events until end of study (up to Day 21)
|
Part 2: Dabigatran Etexilate 150 mg
n=16 participants at risk
Participants received single oral dose of dabigatran etexilate 150 mg capsule on Day 1
|
Part 2: Camlipixant 50 mg
n=15 participants at risk
Participants received repeated oral doses of camlipixant 50 mg tablet twice daily (BID) (total daily dose of 100 mg) from Days 5 to 10.
|
Part 2: Dabigatran Etexilate 150 mg+ Camlipixant 50 mg
n=14 participants at risk
Participants received repeated oral doses of camlipixant 50 mg tablet twice daily (BID) (total daily dose of 100 mg) from Days 5 to 9, with co-administration of a single oral dose of dabigatran etexilate 150 mg capsule with the morning dose of camlipixant on Day 10. Participants were followed up for adverse events until end of study (up to Day 22).
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
6.2%
1/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/15 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/14 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
6.2%
1/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/15 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/14 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
|
Investigations
Thyroxine free decreased
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
6.2%
1/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/15 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/14 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
6.2%
1/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/15 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/14 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
|
Nervous system disorders
Headache
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
6.2%
1/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
6.2%
1/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
6.7%
1/15 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/14 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
|
Psychiatric disorders
Affect lability
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
6.2%
1/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/15 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/14 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
|
Gastrointestinal disorders
Constipation
|
6.2%
1/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
6.2%
1/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
6.2%
1/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
6.7%
1/15 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/14 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
6.2%
1/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
13.3%
2/15 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/14 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
6.2%
1/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/15 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/14 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
6.2%
1/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
6.7%
1/15 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/14 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
6.2%
1/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/15 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/14 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
6.2%
1/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/15 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/14 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
|
General disorders
Feeling hot
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
6.2%
1/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/15 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/14 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
|
General disorders
Chest discomfort
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
6.2%
1/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/15 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/14 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
|
General disorders
Feeling abnormal
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
6.2%
1/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/15 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/14 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
6.2%
1/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
6.7%
1/15 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/14 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
6.2%
1/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
6.7%
1/15 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/14 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
|
Investigations
Blood pressure increased
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
6.2%
1/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/15 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/14 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
|
Investigations
Heart rate increased
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
6.2%
1/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/15 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/14 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
6.2%
1/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/15 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/14 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
6.7%
1/15 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/14 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
6.2%
1/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/15 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/14 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
6.2%
1/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/15 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/14 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
6.7%
1/15 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/14 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
6.2%
1/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/15 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/14 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
6.2%
1/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/15 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/14 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
|
Eye disorders
Dry eye
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
6.7%
1/15 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/14 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
|
Eye disorders
Photophobia
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
6.2%
1/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/15 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/14 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
6.7%
1/15 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/14 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
6.7%
1/15 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/14 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/16 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
6.7%
1/15 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
0.00%
0/14 • Part1(Day1 postdose until Day5 predose of gemfibrozil [Camlipixant 50mg];from Day5 dosing until Day9 predose of camlipixant[Gemfibrozil 600mg];from camlipixant dosing on Day9 until end of study[Day21] [Camlipixant 50mg+Gemfibrozil 600mg]) and Part2(Day1 postdose until Day5 predose of camlipixant[Dabigatran etexilate 150mg];from Day5 dosing until Day10 predose of dabigatran[Camlipixant 50mg];from dabigatran dosing on Day10 until end of study [Day22] [Dabigatran etexilate 150mg+camlipixant 50mg])
Safety Population comprised of all participants who received at least one dose of any study drug. AEs were reported treatment-wise.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER