Trial Outcomes & Findings for Evaluation of the Effect of Rifampin and Rabeprazole on the Pharmacokinetics of Camlipixant (NCT NCT05899829)
NCT ID: NCT05899829
Last Updated: 2024-12-04
Results Overview
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods.
COMPLETED
PHASE1
42 participants
Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11
2024-12-04
Participant Flow
A total of 42 participants were enrolled (20 participants in Part 1 and 22 participants in Part 2) in this study. Only 32 participants (10 participants were never dosed) were dosed into the study to receive either camlipixant + rifampin or camlipixant + rabeprazole creating the Safety Population.
Participant milestones
| Measure |
Part 1: Camlipixant 50 mg + Rifampin 600 mg
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4.
|
Part 2: Camlipixant 50 mg + Rabeprazole 20 mg
Participants received a single oral dose of camlipixant 50 mg tablet on Day 1, followed by repeat oral doses of 20 mg rabeprazole enteric-coated tablets, once daily (QD) from Days 4 to 11, with co-administration of a single oral dose of 50 mg camlipixant tablet with rabeprazole enteric-coated tablet on Day 10. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rabeprazole on Day 4.
|
|---|---|---|
|
Part 1 (Up to Day 22)
STARTED
|
20
|
0
|
|
Part 1 (Up to Day 22)
Safety Population
|
16
|
0
|
|
Part 1 (Up to Day 22)
COMPLETED
|
16
|
0
|
|
Part 1 (Up to Day 22)
NOT COMPLETED
|
4
|
0
|
|
Part 2 (up to Day 21)
STARTED
|
0
|
22
|
|
Part 2 (up to Day 21)
Safety Population
|
0
|
16
|
|
Part 2 (up to Day 21)
COMPLETED
|
0
|
16
|
|
Part 2 (up to Day 21)
NOT COMPLETED
|
0
|
6
|
Reasons for withdrawal
| Measure |
Part 1: Camlipixant 50 mg + Rifampin 600 mg
Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4.
|
Part 2: Camlipixant 50 mg + Rabeprazole 20 mg
Participants received a single oral dose of camlipixant 50 mg tablet on Day 1, followed by repeat oral doses of 20 mg rabeprazole enteric-coated tablets, once daily (QD) from Days 4 to 11, with co-administration of a single oral dose of 50 mg camlipixant tablet with rabeprazole enteric-coated tablet on Day 10. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rabeprazole on Day 4.
|
|---|---|---|
|
Part 1 (Up to Day 22)
Enrolled but did not receive study treatment
|
4
|
0
|
|
Part 2 (up to Day 21)
Enrolled but did not receive study treatment
|
0
|
6
|
Baseline Characteristics
Evaluation of the Effect of Rifampin and Rabeprazole on the Pharmacokinetics of Camlipixant
Baseline characteristics by cohort
| Measure |
Part 1: Camlipixant 50 mg + Rifampin 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 (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4.
|
Part 2: Camlipixant 50 mg + Rabeprazole 20 mg
n=16 Participants
Participants received a single oral dose of camlipixant 50 mg tablet on Day 1, followed by repeat oral doses of 20 mg rabeprazole enteric-coated tablets, once daily (QD) from Days 4 to 11, with co-administration of a single oral dose of 50 mg camlipixant tablet with rabeprazole enteric-coated tablet on Day 10. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rabeprazole on Day 4.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18 to 55 years
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Others
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11Population: Pharmacokinetic Parameter Population comprised of all participants for whom the Day 1 and Day 11 (Part 1) PK profiles of Camlipixant were adequately characterized, specifically, when administered alone and in combination with Rifampin (Part 1).
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: Camlipixant 50 mg + Rifampin 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 (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4.
|
Part 1: Rifampin 600 mg
Participants received repeated oral doses of 2\*300 mg rifampin capsules (total dose 600 mg) once daily on Days 4 to 12.
|
Part 1: Camlipixant 50 mg+ Rifampin 600 mg
Participants received repeat oral doses (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11.Participants were followed up for adverse events until end of study (up to Day 22)
|
|---|---|---|---|
|
Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-Infinity]) of Camlipixant
Day 1
|
3851.24 Hours*nanograms per milliliter
Geometric Coefficient of Variation 39.27
|
—
|
—
|
|
Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-Infinity]) of Camlipixant
Day 11
|
1423.84 Hours*nanograms per milliliter
Geometric Coefficient of Variation 38.90
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10Population: Pharmacokinetic Parameter Population comprised of all participants for whom the Day 1 and Day 10 (Part 2) PK profiles of Camlipixant, were adequately characterized, specifically, when administered alone and in combination with Rabeprazole (Part 2).
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 + Rifampin 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 (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4.
|
Part 1: Rifampin 600 mg
Participants received repeated oral doses of 2\*300 mg rifampin capsules (total dose 600 mg) once daily on Days 4 to 12.
|
Part 1: Camlipixant 50 mg+ Rifampin 600 mg
Participants received repeat oral doses (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11.Participants were followed up for adverse events until end of study (up to Day 22)
|
|---|---|---|---|
|
Part 2: AUC(0-Infinity) of Camlipixant
Day 1
|
5425.54 Hours*nanograms per milliliter
Geometric Coefficient of Variation 29.55
|
—
|
—
|
|
Part 2: AUC(0-Infinity) of Camlipixant
Day 10
|
5514.74 Hours*nanograms per milliliter
Geometric Coefficient of Variation 33.39
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11Population: Pharmacokinetic Parameter Population comprised of all participants for whom the Day 1 and Day 11 (Part 1) PK profiles of Camlipixant were adequately characterized, specifically, when administered alone and in combination with Rifampin (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 + Rifampin 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 (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4.
|
Part 1: Rifampin 600 mg
Participants received repeated oral doses of 2\*300 mg rifampin capsules (total dose 600 mg) once daily on Days 4 to 12.
|
Part 1: Camlipixant 50 mg+ Rifampin 600 mg
Participants received repeat oral doses (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11.Participants were followed up for adverse events until end of study (up to Day 22)
|
|---|---|---|---|
|
Part 1: Area Under the Plasma Concentration-time Curve From Time Zero Until the Last Observed Concentration (AUC[0-t]) of Camlipixant
Day 1
|
3834.41 Hours*nanograms per milliliter
Geometric Coefficient of Variation 39.31
|
—
|
—
|
|
Part 1: Area Under the Plasma Concentration-time Curve From Time Zero Until the Last Observed Concentration (AUC[0-t]) of Camlipixant
Day 11
|
1419.39 Hours*nanograms per milliliter
Geometric Coefficient of Variation 38.97
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10Population: Pharmacokinetic Parameter Population comprised of all participants for whom the Day 1 and Day 10 (Part 2) PK profiles of Camlipixant, were adequately characterized, specifically, when administered alone and in combination with Rabeprazole (Part 2).
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 + Rifampin 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 (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4.
|
Part 1: Rifampin 600 mg
Participants received repeated oral doses of 2\*300 mg rifampin capsules (total dose 600 mg) once daily on Days 4 to 12.
|
Part 1: Camlipixant 50 mg+ Rifampin 600 mg
Participants received repeat oral doses (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11.Participants were followed up for adverse events until end of study (up to Day 22)
|
|---|---|---|---|
|
Part 2: AUC(0-t) of Camlipixant
Day 1
|
5403.91 Hours*nanograms per milliliter
Geometric Coefficient of Variation 29.52
|
—
|
—
|
|
Part 2: AUC(0-t) of Camlipixant
Day 10
|
5474.24 Hours*nanograms per milliliter
Geometric Coefficient of Variation 33.07
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11Population: Pharmacokinetic Parameter Population comprised of all participants for whom the Day 1 and Day 11 (Part 1) PK profiles of Camlipixant were adequately characterized, specifically, when administered alone and in combination with Rifampin (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 + Rifampin 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 (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4.
|
Part 1: Rifampin 600 mg
Participants received repeated oral doses of 2\*300 mg rifampin capsules (total dose 600 mg) once daily on Days 4 to 12.
|
Part 1: Camlipixant 50 mg+ Rifampin 600 mg
Participants received repeat oral doses (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11.Participants were followed up for adverse events until end of study (up to Day 22)
|
|---|---|---|---|
|
Part 1: Maximum Observed Concentration (Cmax) of Camlipixant
Day 1
|
819 Nanograms per milliliter
Geometric Coefficient of Variation 19.54
|
—
|
—
|
|
Part 1: Maximum Observed Concentration (Cmax) of Camlipixant
Day 11
|
519 Nanograms per milliliter
Geometric Coefficient of Variation 27.84
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10Population: Pharmacokinetic Parameter Population comprised of all participants for whom the Day 1 and Day 10 (Part 2) PK profiles of Camlipixant, were adequately characterized, specifically, when administered alone and in combination with Rabeprazole (Part 2).
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 + Rifampin 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 (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4.
|
Part 1: Rifampin 600 mg
Participants received repeated oral doses of 2\*300 mg rifampin capsules (total dose 600 mg) once daily on Days 4 to 12.
|
Part 1: Camlipixant 50 mg+ Rifampin 600 mg
Participants received repeat oral doses (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11.Participants were followed up for adverse events until end of study (up to Day 22)
|
|---|---|---|---|
|
Part 2: Cmax of Camlipixant
Day 1
|
1080 Nanograms per milliliter
Geometric Coefficient of Variation 24.74
|
—
|
—
|
|
Part 2: Cmax of Camlipixant
Day 10
|
912 Nanograms per milliliter
Geometric Coefficient of Variation 34.29
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11Population: Pharmacokinetic Parameter Population comprised of all participants for whom the Day 1 and Day 11 (Part 1) PK profiles of Camlipixant were adequately characterized, specifically, when administered alone and in combination with Rifampin (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 + Rifampin 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 (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4.
|
Part 1: Rifampin 600 mg
Participants received repeated oral doses of 2\*300 mg rifampin capsules (total dose 600 mg) once daily on Days 4 to 12.
|
Part 1: Camlipixant 50 mg+ Rifampin 600 mg
Participants received repeat oral doses (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11.Participants were followed up for adverse events until end of study (up to Day 22)
|
|---|---|---|---|
|
Part 1: Time to Reach Maximum Observed Concentration (Tmax) of Camlipixant
Day 1
|
1.000 Hours
Interval 0.25 to 2.5
|
—
|
—
|
|
Part 1: Time to Reach Maximum Observed Concentration (Tmax) of Camlipixant
Day 11
|
0.750 Hours
Interval 0.5 to 3.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10Population: Pharmacokinetic Parameter Population comprised of all participants for whom the Day 1 and Day 10 (Part 2) PK profiles of Camlipixant, were adequately characterized, specifically, when administered alone and in combination with Rabeprazole (Part 2).
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 + Rifampin 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 (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4.
|
Part 1: Rifampin 600 mg
Participants received repeated oral doses of 2\*300 mg rifampin capsules (total dose 600 mg) once daily on Days 4 to 12.
|
Part 1: Camlipixant 50 mg+ Rifampin 600 mg
Participants received repeat oral doses (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11.Participants were followed up for adverse events until end of study (up to Day 22)
|
|---|---|---|---|
|
Part 2: Tmax of Camlipixant
Day 10
|
1.750 Hours
Interval 0.6 to 4.017
|
—
|
—
|
|
Part 2: Tmax of Camlipixant
Day 1
|
0.750 Hours
Interval 0.5 to 1.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11Population: Pharmacokinetic Parameter Population comprised of all participants for whom the Day 1 and Day 11 (Part 1) PK profiles of Camlipixant were adequately characterized, specifically, when administered alone and in combination with Rifampin (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 + Rifampin 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 (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4.
|
Part 1: Rifampin 600 mg
Participants received repeated oral doses of 2\*300 mg rifampin capsules (total dose 600 mg) once daily on Days 4 to 12.
|
Part 1: Camlipixant 50 mg+ Rifampin 600 mg
Participants received repeat oral doses (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11.Participants were followed up for adverse events until end of study (up to Day 22)
|
|---|---|---|---|
|
Part 1: Terminal Elimination Half-Life (T1/2) Following Administration of Camlipixant
Day 1
|
5.05 Hours
Geometric Coefficient of Variation 32.02
|
—
|
—
|
|
Part 1: Terminal Elimination Half-Life (T1/2) Following Administration of Camlipixant
Day 11
|
1.94 Hours
Geometric Coefficient of Variation 28.68
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10Population: Pharmacokinetic Parameter Population comprised of all participants for whom the Day 1 and Day 10 (Part 2) PK profiles of Camlipixant, were adequately characterized, specifically, when administered alone and in combination with Rabeprazole (Part 2).
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 + Rifampin 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 (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4.
|
Part 1: Rifampin 600 mg
Participants received repeated oral doses of 2\*300 mg rifampin capsules (total dose 600 mg) once daily on Days 4 to 12.
|
Part 1: Camlipixant 50 mg+ Rifampin 600 mg
Participants received repeat oral doses (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11.Participants were followed up for adverse events until end of study (up to Day 22)
|
|---|---|---|---|
|
Part 2: T1/2 Following Administration of Camlipixant
Day 1
|
6.01 Hours
Geometric Coefficient of Variation 16.90
|
—
|
—
|
|
Part 2: T1/2 Following Administration of Camlipixant
Day 10
|
6.78 Hours
Geometric Coefficient of Variation 17.01
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11Population: Pharmacokinetic Parameter Population comprised of all participants for whom the Day 1 and Day 11 (Part 1) PK profiles of Camlipixant were adequately characterized, specifically, when administered alone and in combination with Rifampin (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 + Rifampin 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 (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4.
|
Part 1: Rifampin 600 mg
Participants received repeated oral doses of 2\*300 mg rifampin capsules (total dose 600 mg) once daily on Days 4 to 12.
|
Part 1: Camlipixant 50 mg+ Rifampin 600 mg
Participants received repeat oral doses (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11.Participants were followed up for adverse events until end of study (up to Day 22)
|
|---|---|---|---|
|
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
|
0.40 Percentage of AUC extrapolation
Geometric Coefficient of Variation 45.60
|
—
|
—
|
|
Part 1: Percentage of AUC0-Infinity Due to Extrapolation From the Time of the Last Observed Concentration to Infinity (% AUC Extrapolation) of Camlipixant
Day 11
|
0.30 Percentage of AUC extrapolation
Geometric Coefficient of Variation 33.74
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10Population: Pharmacokinetic Parameter Population comprised of all participants for whom the Day 1 and Day 10 (Part 2) PK profiles of Camlipixant, were adequately characterized, specifically, when administered alone and in combination with Rabeprazole (Part 2).
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 + Rifampin 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 (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4.
|
Part 1: Rifampin 600 mg
Participants received repeated oral doses of 2\*300 mg rifampin capsules (total dose 600 mg) once daily on Days 4 to 12.
|
Part 1: Camlipixant 50 mg+ Rifampin 600 mg
Participants received repeat oral doses (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11.Participants were followed up for adverse events until end of study (up to Day 22)
|
|---|---|---|---|
|
Part 2: % AUC Extrapolation of Camlipixant
Day 1
|
0.34 Percentage of AUC extrapolation
Geometric Coefficient of Variation 54.00
|
—
|
—
|
|
Part 2: % AUC Extrapolation of Camlipixant
Day 10
|
0.57 Percentage of AUC extrapolation
Geometric Coefficient of Variation 84.03
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11Population: Pharmacokinetic Parameter Population comprised of all participants for whom the Day 1 and Day 11 (Part 1) PK profiles of Camlipixant were adequately characterized, specifically, when administered alone and in combination with Rifampin (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 + Rifampin 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 (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4.
|
Part 1: Rifampin 600 mg
Participants received repeated oral doses of 2\*300 mg rifampin capsules (total dose 600 mg) once daily on Days 4 to 12.
|
Part 1: Camlipixant 50 mg+ Rifampin 600 mg
Participants received repeat oral doses (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11.Participants were followed up for adverse events until end of study (up to Day 22)
|
|---|---|---|---|
|
Part 1: Terminal Elimination Rate Constant of Camlipixant
Day 1
|
0.1372 Per hour
Geometric Coefficient of Variation 32.02
|
—
|
—
|
|
Part 1: Terminal Elimination Rate Constant of Camlipixant
Day 11
|
0.3579 Per hour
Geometric Coefficient of Variation 28.68
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10Population: Pharmacokinetic Parameter Population comprised of all participants for whom the Day 1 and Day 10 (Part 2) PK profiles of Camlipixant, were adequately characterized, specifically, when administered alone and in combination with Rabeprazole (Part 2).
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 + Rifampin 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 (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4.
|
Part 1: Rifampin 600 mg
Participants received repeated oral doses of 2\*300 mg rifampin capsules (total dose 600 mg) once daily on Days 4 to 12.
|
Part 1: Camlipixant 50 mg+ Rifampin 600 mg
Participants received repeat oral doses (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11.Participants were followed up for adverse events until end of study (up to Day 22)
|
|---|---|---|---|
|
Part 2: Terminal Elimination Rate Constant of Camlipixant
Day 1
|
0.1153 Per hour
Geometric Coefficient of Variation 16.90
|
—
|
—
|
|
Part 2: Terminal Elimination Rate Constant of Camlipixant
Day 10
|
0.1022 Per hour
Geometric Coefficient of Variation 17.01
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11Population: Pharmacokinetic Parameter Population comprised of all participants for whom the Day 1 and Day 11 (Part 1) PK profiles of Camlipixant were adequately characterized, specifically, when administered alone and in combination with Rifampin (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 + Rifampin 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 (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4.
|
Part 1: Rifampin 600 mg
Participants received repeated oral doses of 2\*300 mg rifampin capsules (total dose 600 mg) once daily on Days 4 to 12.
|
Part 1: Camlipixant 50 mg+ Rifampin 600 mg
Participants received repeat oral doses (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11.Participants were followed up for adverse events until end of study (up to Day 22)
|
|---|---|---|---|
|
Part 1: Apparent Clearance (CL/F) of Camlipixant
Day 1
|
12.98 Liters per hour
Geometric Coefficient of Variation 39.27
|
—
|
—
|
|
Part 1: Apparent Clearance (CL/F) of Camlipixant
Day 11
|
35.12 Liters per hour
Geometric Coefficient of Variation 38.90
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10Population: Pharmacokinetic Parameter Population comprised of all participants for whom the Day 1 and Day 10 (Part 2) PK profiles of Camlipixant, were adequately characterized, specifically, when administered alone and in combination with Rabeprazole (Part 2).
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 + Rifampin 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 (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4.
|
Part 1: Rifampin 600 mg
Participants received repeated oral doses of 2\*300 mg rifampin capsules (total dose 600 mg) once daily on Days 4 to 12.
|
Part 1: Camlipixant 50 mg+ Rifampin 600 mg
Participants received repeat oral doses (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11.Participants were followed up for adverse events until end of study (up to Day 22)
|
|---|---|---|---|
|
Part 2: CL/F of Camlipixant
Day 1
|
9.22 Liters per hour
Geometric Coefficient of Variation 29.55
|
—
|
—
|
|
Part 2: CL/F of Camlipixant
Day 10
|
9.07 Liters per hour
Geometric Coefficient of Variation 33.39
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11Population: Pharmacokinetic Parameter Population comprised of all participants for whom the Day 1 and Day 11 (Part 1) PK profiles of Camlipixant were adequately characterized, specifically, when administered alone and in combination with Rifampin (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 + Rifampin 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 (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4.
|
Part 1: Rifampin 600 mg
Participants received repeated oral doses of 2\*300 mg rifampin capsules (total dose 600 mg) once daily on Days 4 to 12.
|
Part 1: Camlipixant 50 mg+ Rifampin 600 mg
Participants received repeat oral doses (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11.Participants were followed up for adverse events until end of study (up to Day 22)
|
|---|---|---|---|
|
Part 1: Apparent Oral Volume of Distribution (Vz/F) of Camlipixant
Day 1
|
94.66 Liters
Geometric Coefficient of Variation 26.40
|
—
|
—
|
|
Part 1: Apparent Oral Volume of Distribution (Vz/F) of Camlipixant
Day 11
|
98.11 Liters
Geometric Coefficient of Variation 29.90
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10Population: Pharmacokinetic Parameter Population comprised of all participants for whom the Day 1 and Day 10 (Part 2) PK profiles of Camlipixant, were adequately characterized, specifically, when administered alone and in combination with Rabeprazole (Part 2).
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 + Rifampin 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 (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4.
|
Part 1: Rifampin 600 mg
Participants received repeated oral doses of 2\*300 mg rifampin capsules (total dose 600 mg) once daily on Days 4 to 12.
|
Part 1: Camlipixant 50 mg+ Rifampin 600 mg
Participants received repeat oral doses (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11.Participants were followed up for adverse events until end of study (up to Day 22)
|
|---|---|---|---|
|
Part 2: Vz/F of Camlipixant
Day 1
|
79.96 Liters
Geometric Coefficient of Variation 31.72
|
—
|
—
|
|
Part 2: Vz/F of Camlipixant
Day 10
|
88.74 Liters
Geometric Coefficient of Variation 26.78
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 22 for Part1 (Day1 post-dose until Day4 pre-dose of rifampin [Camlipixant 50mg];From Day4 dosing until Day11 pre-dose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study [Day 22] [Camlipixant 50mg+Rifampin 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 hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. Adverse events of medical interest (AEMIs) are AEs of scientific interest specific to the drug class. 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 + Rifampin 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 (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4.
|
Part 1: Rifampin 600 mg
n=16 Participants
Participants received repeated oral doses of 2\*300 mg rifampin capsules (total dose 600 mg) once daily on Days 4 to 12.
|
Part 1: Camlipixant 50 mg+ Rifampin 600 mg
n=16 Participants
Participants received repeat oral doses (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11.Participants were followed up for adverse events until end of study (up to Day 22)
|
|---|---|---|---|
|
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
|
3 Participants
|
14 Participants
|
2 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
|
0 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
|
0 Participants
|
SECONDARY outcome
Timeframe: Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]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 hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. Adverse events of medical interest (AEMIs) are AEs of scientific interest specific to the drug class. 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 + Rifampin 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 (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4.
|
Part 1: Rifampin 600 mg
n=16 Participants
Participants received repeated oral doses of 2\*300 mg rifampin capsules (total dose 600 mg) once daily on Days 4 to 12.
|
Part 1: Camlipixant 50 mg+ Rifampin 600 mg
n=16 Participants
Participants received repeat oral doses (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11.Participants were followed up for adverse events until end of study (up to Day 22)
|
|---|---|---|---|
|
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
TEAEs
|
4 Participants
|
3 Participants
|
0 Participants
|
|
Part 2: Number of Participants With TEAEs, TESAEs and TEAEMIs
TEAEMIs
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 4, Day 11, 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 + Rifampin 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 (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4.
|
Part 1: Rifampin 600 mg
Participants received repeated oral doses of 2\*300 mg rifampin capsules (total dose 600 mg) once daily on Days 4 to 12.
|
Part 1: Camlipixant 50 mg+ Rifampin 600 mg
Participants received repeat oral doses (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11.Participants were followed up for adverse events until end of study (up to Day 22)
|
|---|---|---|---|
|
Part 1: Number of Participants With Abnormal Clinically Significant Changes in 12-Lead Electrocardiogram (ECG) Findings
Day 4
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Abnormal Clinically Significant Changes in 12-Lead Electrocardiogram (ECG) Findings
Day 11
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Abnormal Clinically Significant Changes in 12-Lead Electrocardiogram (ECG) Findings
Day 13
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 4, Day 10, and 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 + Rifampin 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 (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4.
|
Part 1: Rifampin 600 mg
Participants received repeated oral doses of 2\*300 mg rifampin capsules (total dose 600 mg) once daily on Days 4 to 12.
|
Part 1: Camlipixant 50 mg+ Rifampin 600 mg
Participants received repeat oral doses (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11.Participants were followed up for adverse events until end of study (up to Day 22)
|
|---|---|---|---|
|
Part 2: Number of Participants With Abnormal Clinically Significant Changes in 12-Lead ECG Findings
Day 12
|
0 Participants
|
—
|
—
|
|
Part 2: Number of Participants With Abnormal Clinically Significant Changes in 12-Lead ECG Findings
Day 4
|
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 11 and Day 13Population: Safety population consisted of all participants who received at least one dose of any study drug.
Vital signs including diastolic blood pressure (DBP), systolic Blood Pressure (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 + Rifampin 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 (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4.
|
Part 1: Rifampin 600 mg
Participants received repeated oral doses of 2\*300 mg rifampin capsules (total dose 600 mg) once daily on Days 4 to 12.
|
Part 1: Camlipixant 50 mg+ Rifampin 600 mg
Participants received repeat oral doses (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11.Participants were followed up for adverse events until end of study (up to Day 22)
|
|---|---|---|---|
|
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 11
|
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 13
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 10 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 + Rifampin 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 (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4.
|
Part 1: Rifampin 600 mg
Participants received repeated oral doses of 2\*300 mg rifampin capsules (total dose 600 mg) once daily on Days 4 to 12.
|
Part 1: Camlipixant 50 mg+ Rifampin 600 mg
Participants received repeat oral doses (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11.Participants were followed up for adverse events until end of study (up to Day 22)
|
|---|---|---|---|
|
Part 2: Number of Participants With Abnormal Clinically Significant Changes in Vital Signs: DBP, SBP, and Heart Rate
Day 10
|
0 Participants
|
—
|
—
|
|
Part 2: Number of Participants With Abnormal Clinically Significant Changes in Vital Signs: DBP, SBP, and Heart Rate
Day 12
|
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 + Rifampin 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 (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4.
|
Part 1: Rifampin 600 mg
Participants received repeated oral doses of 2\*300 mg rifampin capsules (total dose 600 mg) once daily on Days 4 to 12.
|
Part 1: Camlipixant 50 mg+ Rifampin 600 mg
Participants received repeat oral doses (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11.Participants were followed up for adverse events until end of study (up to Day 22)
|
|---|---|---|---|
|
Part 1: Number of Participants With Abnormal Clinically Significant Changes in Vital Signs: Respiratory Rate and Oral Temperature
|
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 + Rifampin 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 (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4.
|
Part 1: Rifampin 600 mg
Participants received repeated oral doses of 2\*300 mg rifampin capsules (total dose 600 mg) once daily on Days 4 to 12.
|
Part 1: Camlipixant 50 mg+ Rifampin 600 mg
Participants received repeat oral doses (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11.Participants were followed up for adverse events until end of study (up to Day 22)
|
|---|---|---|---|
|
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 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 + Rifampin 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 (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4.
|
Part 1: Rifampin 600 mg
Participants received repeated oral doses of 2\*300 mg rifampin capsules (total dose 600 mg) once daily on Days 4 to 12.
|
Part 1: Camlipixant 50 mg+ Rifampin 600 mg
Participants received repeat oral doses (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11.Participants were followed up for adverse events until end of study (up to Day 22)
|
|---|---|---|---|
|
Part 1: Number of Participants With Abnormal Clinically Significant Changes in 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.
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 + Rifampin 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 (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4.
|
Part 1: Rifampin 600 mg
Participants received repeated oral doses of 2\*300 mg rifampin capsules (total dose 600 mg) once daily on Days 4 to 12.
|
Part 1: Camlipixant 50 mg+ Rifampin 600 mg
Participants received repeat oral doses (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11.Participants were followed up for adverse events until end of study (up to Day 22)
|
|---|---|---|---|
|
Part 2: Number of Participants With Abnormal Clinically Significant Changes in Physical Examination
|
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 + Rifampin 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 (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4.
|
Part 1: Rifampin 600 mg
Participants received repeated oral doses of 2\*300 mg rifampin capsules (total dose 600 mg) once daily on Days 4 to 12.
|
Part 1: Camlipixant 50 mg+ Rifampin 600 mg
Participants received repeat oral doses (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11.Participants were followed up for adverse events until end of study (up to Day 22)
|
|---|---|---|---|
|
Part 1: 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 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 + Rifampin 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 (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4.
|
Part 1: Rifampin 600 mg
Participants received repeated oral doses of 2\*300 mg rifampin capsules (total dose 600 mg) once daily on Days 4 to 12.
|
Part 1: Camlipixant 50 mg+ Rifampin 600 mg
Participants received repeat oral doses (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11.Participants were followed up for adverse events until end of study (up to Day 22)
|
|---|---|---|---|
|
Part 2: 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 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 + Rifampin 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 (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4.
|
Part 1: Rifampin 600 mg
Participants received repeated oral doses of 2\*300 mg rifampin capsules (total dose 600 mg) once daily on Days 4 to 12.
|
Part 1: Camlipixant 50 mg+ Rifampin 600 mg
Participants received repeat oral doses (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11.Participants were followed up for adverse events until end of study (up to Day 22)
|
|---|---|---|---|
|
Part 1: Number of Participants With Abnormal Clinically Significant Changes in Clinical Chemistry Parameters
|
2 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 + Rifampin 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 (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4.
|
Part 1: Rifampin 600 mg
Participants received repeated oral doses of 2\*300 mg rifampin capsules (total dose 600 mg) once daily on Days 4 to 12.
|
Part 1: Camlipixant 50 mg+ Rifampin 600 mg
Participants received repeat oral doses (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11.Participants were followed up for adverse events until end of study (up to Day 22)
|
|---|---|---|---|
|
Part 2: Number of Participants With Abnormal Clinically Significant Changes in Clinical Chemistry 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 (Intl.) normalized ratio, 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 + Rifampin 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 (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4.
|
Part 1: Rifampin 600 mg
Participants received repeated oral doses of 2\*300 mg rifampin capsules (total dose 600 mg) once daily on Days 4 to 12.
|
Part 1: Camlipixant 50 mg+ Rifampin 600 mg
Participants received repeat oral doses (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11.Participants were followed up for adverse events until end of study (up to Day 22)
|
|---|---|---|---|
|
Part 1: 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.
Blood samples were collected to analyze coagulation parameters: activated partial thromboplastin time, prothrombin time international (Intl.) normalized ratio, 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 + Rifampin 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 (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4.
|
Part 1: Rifampin 600 mg
Participants received repeated oral doses of 2\*300 mg rifampin capsules (total dose 600 mg) once daily on Days 4 to 12.
|
Part 1: Camlipixant 50 mg+ Rifampin 600 mg
Participants received repeat oral doses (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11.Participants were followed up for adverse events until end of study (up to Day 22)
|
|---|---|---|---|
|
Part 2: 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.
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 + Rifampin 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 (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4.
|
Part 1: Rifampin 600 mg
Participants received repeated oral doses of 2\*300 mg rifampin capsules (total dose 600 mg) once daily on Days 4 to 12.
|
Part 1: Camlipixant 50 mg+ Rifampin 600 mg
Participants received repeat oral doses (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11.Participants were followed up for adverse events until end of study (up to Day 22)
|
|---|---|---|---|
|
Part 1: Number of Participants With Abnormal Clinically Significant Changes in Urinalysis
|
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 + Rifampin 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 (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There was a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4.
|
Part 1: Rifampin 600 mg
Participants received repeated oral doses of 2\*300 mg rifampin capsules (total dose 600 mg) once daily on Days 4 to 12.
|
Part 1: Camlipixant 50 mg+ Rifampin 600 mg
Participants received repeat oral doses (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11.Participants were followed up for adverse events until end of study (up to Day 22)
|
|---|---|---|---|
|
Part 2: Number of Participants With Abnormal Clinically Significant Changes in Urinalysis
|
0 Participants
|
—
|
—
|
Adverse Events
Part 1: Camlipixant 50 mg
Part 1: Rifampin 600 mg
Part 1: Camlipixant 50 mg+ Rifampin 600 mg
Part 2: Camlipixant 50 mg
Part 2 : Rabeprazole 20 mg
Part 2: Camlipixant 50 mg+ Rabeprazole 20 mg
Serious adverse events
Adverse event data not reported
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: Rifampin 600 mg
n=16 participants at risk
Participants received repeated oral doses of 2\*300 mg rifampin capsules (total dose 600 mg) once daily on Days 4 to 12.
|
Part 1: Camlipixant 50 mg+ Rifampin 600 mg
n=16 participants at risk
Participants received repeat oral doses (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. Participants were followed up for adverse events until end of study (up to Day 22)
|
Part 2: Camlipixant 50 mg
n=16 participants at risk
Participants received a single oral dose of 50 mg camlipixant tablet on Day 1.
|
Part 2 : Rabeprazole 20 mg
n=16 participants at risk
Participants received repeated oral doses of 1\*20 mg rabeprazole enteric-coated tablets once daily on Days 4 to 11.
|
Part 2: Camlipixant 50 mg+ Rabeprazole 20 mg
n=16 participants at risk
Participants received repeat oral doses of 20 mg rabeprazole enteric-coated tablets, once daily (QD) from Days 4 to 11, with co-administration of a single oral dose of 50 mg camlipixant tablet with rabeprazole enteric-coated tablet on Day 10. Participants were followed up for adverse events until end of study (up to Day 21).
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
6.2%
1/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
6.2%
1/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
6.2%
1/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal paraesthesia
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
6.2%
1/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
81.2%
13/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
|
Renal and urinary disorders
Pollakiuria
|
6.2%
1/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
12.5%
2/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
6.2%
1/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
6.2%
1/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
6.2%
1/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
6.2%
1/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
6.2%
1/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
6.2%
1/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
6.2%
1/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
|
General disorders
Chills
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
6.2%
1/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
|
General disorders
Fatigue
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
6.2%
1/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
|
General disorders
Feeling hot
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
6.2%
1/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
1/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
6.2%
1/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
6.2%
1/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
12.5%
2/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
6.2%
1/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
6.2%
1/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
|
Skin and subcutaneous tissue disorders
Seborrhoea
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
6.2%
1/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
6.2%
1/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
6.2%
1/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
|
Psychiatric disorders
Insomnia
|
6.2%
1/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
6.2%
1/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
6.2%
1/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
6.2%
1/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
6.2%
1/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
6.2%
1/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
|
Eye disorders
Photophobia
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
6.2%
1/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
6.2%
1/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
6.2%
1/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-wise.
|
0.00%
0/16 • Upto Day22 for Part1(Day1 postdose until Day4 predose of rifampin[Camlipixant 50mg];From Day4 dosing until Day11 predose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study[Day22] [Camlipixant 50mg+Rifampin 600mg]. Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
Safety Population comprised of all participants who received at least one dose of any study drug. Adverse events were reported treatment-wise and part-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