Trial Outcomes & Findings for A Study of Camlipixant in Male and Female Healthy Participants and Participants With Hepatic Impairment Aged 18-75 Years of Age (NCT NCT06222892)
NCT ID: NCT06222892
Last Updated: 2026-01-07
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
32 participants
Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose
2026-01-07
Participant Flow
This study consisted of 2 parts - Part 1 and Part 2. In Part 1, participants with moderate hepatic impairment (HI) and matched healthy participants were enrolled. Based on the pharmacokinetic (PK) and safety data from Part 1, only participants with severe HI and their matched healthy participants were enrolled in Part 2, while participants with mild HI were not enrolled.
A total of 32 participants (16 in Part 1 and 16 in Part 2) were enrolled in this study.
Participant milestones
| Measure |
Part 1: Moderate HI Participants
Participants with moderate HI received a single dose of camlipixant 50 milligrams (mg) tablet orally on Day 1 in the fasted state.
|
Part 1: Matched Healthy Participants to Moderate HI
Healthy participants (matched to participants with moderate HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
Part 2: Severe HI Participants
Participants with severe HI received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
Part 2: Matched Healthy Participants to Severe HI
Healthy participants (matched to participants with severe HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
|---|---|---|---|---|
|
Part 1 (Up to 17 Days)
STARTED
|
8
|
8
|
0
|
0
|
|
Part 1 (Up to 17 Days)
COMPLETED
|
8
|
8
|
0
|
0
|
|
Part 1 (Up to 17 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Part 2 (Up to 17 Days)
STARTED
|
0
|
0
|
8
|
8
|
|
Part 2 (Up to 17 Days)
COMPLETED
|
0
|
0
|
8
|
8
|
|
Part 2 (Up to 17 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Camlipixant in Male and Female Healthy Participants and Participants With Hepatic Impairment Aged 18-75 Years of Age
Baseline characteristics by cohort
| Measure |
Part 1: Moderate HI Participants
n=8 Participants
Participants with moderate HI received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
Part 1: Matched Healthy Participants to Moderate HI
n=8 Participants
Healthy participants (matched to participants with moderate HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
Part 2: Severe HI Participants
n=8 Participants
Participants with severe HI received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
Part 2: Matched Healthy Participants to Severe HI
n=8 Participants
Healthy participants (matched to participants with severe HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
58.8 YEARS
STANDARD_DEVIATION 9.92 • n=37 Participants
|
56.8 YEARS
STANDARD_DEVIATION 6.96 • n=56 Participants
|
49.9 YEARS
STANDARD_DEVIATION 9.95 • n=95 Participants
|
51.6 YEARS
STANDARD_DEVIATION 9.32 • n=61 Participants
|
54.3 YEARS
STANDARD_DEVIATION 9.42 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=37 Participants
|
4 Participants
n=56 Participants
|
2 Participants
n=95 Participants
|
2 Participants
n=61 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=37 Participants
|
4 Participants
n=56 Participants
|
6 Participants
n=95 Participants
|
6 Participants
n=61 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
8 Participants
n=37 Participants
|
8 Participants
n=56 Participants
|
8 Participants
n=95 Participants
|
8 Participants
n=61 Participants
|
32 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dosePopulation: The analysis was performed on the PK Analysis Set that included all participants who received study intervention and who had at least 1 non-missing PK assessment (non-quantifiable \[NQ\] values were considered as non-missing values).
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: Moderate HI Participants
n=8 Participants
Participants with moderate HI received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
Part 1: Matched Healthy Participants to Moderate HI
n=8 Participants
Healthy participants (matched to participants with moderate HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
|---|---|---|
|
Part 1: Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0-inf]) of Camlipixant
|
5811 Hours*nanograms per milliliter
Geometric Coefficient of Variation 22.7
|
4735 Hours*nanograms per milliliter
Geometric Coefficient of Variation 19.0
|
PRIMARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dosePopulation: The analysis was performed on the PK Analysis Set that included all participants who received study intervention and who had at least 1 non-missing PK assessment (NQ values were considered as non-missing values).
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: Moderate HI Participants
n=8 Participants
Participants with moderate HI received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
Part 1: Matched Healthy Participants to Moderate HI
n=8 Participants
Healthy participants (matched to participants with moderate HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
|---|---|---|
|
Part 2: AUC(0-inf) of Camlipixant
|
7827 Hours*nanograms per milliliter
Geometric Coefficient of Variation 39.9
|
4662 Hours*nanograms per milliliter
Geometric Coefficient of Variation 46.9
|
PRIMARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dosePopulation: The analysis was performed on the PK Analysis Set that included all participants who received study intervention and who had at least 1 non-missing PK assessment (NQ values were considered as non-missing values).
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: Moderate HI Participants
n=8 Participants
Participants with moderate HI received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
Part 1: Matched Healthy Participants to Moderate HI
n=8 Participants
Healthy participants (matched to participants with moderate HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
|---|---|---|
|
Part 1: Maximum Observed Plasma Concentration (Cmax) of Camlipixant
|
1317 Nanograms per milliliter
Geometric Coefficient of Variation 33.5
|
960.0 Nanograms per milliliter
Geometric Coefficient of Variation 30.7
|
PRIMARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dosePopulation: The analysis was performed on the PK Analysis Set that included all participants who received study intervention and who had at least 1 non-missing PK assessment (NQ values were considered as non-missing values).
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: Moderate HI Participants
n=8 Participants
Participants with moderate HI received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
Part 1: Matched Healthy Participants to Moderate HI
n=8 Participants
Healthy participants (matched to participants with moderate HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
|---|---|---|
|
Part 2: Cmax of Camlipixant
|
1228 Nanograms per milliliter
Geometric Coefficient of Variation 38.9
|
985.8 Nanograms per milliliter
Geometric Coefficient of Variation 29.8
|
SECONDARY outcome
Timeframe: Up to 17 daysPopulation: The analysis was performed on the Safety Analysis Set that included all participants who received study intervention.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAEs are defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in a participant's offspring; abnormal pregnancy outcomes; is a suspected transmission of any infectious agent via an authorized medicinal product; or other situations as per medical and scientific judgement of the Investigator. AESIs are AEs of scientific interest specific to the drug class. AESIs for this study include the following but not limited to taste disturbance (dysgeusia, hypogeusia, ageusia), oral paresthesia and oral hypoesthesia. Number of participants with any AE, SAE, or AESI were reported.
Outcome measures
| Measure |
Part 1: Moderate HI Participants
n=8 Participants
Participants with moderate HI received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
Part 1: Matched Healthy Participants to Moderate HI
n=8 Participants
Healthy participants (matched to participants with moderate HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
|---|---|---|
|
Part 1: Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), and Adverse Event of Special Interest (AESI)
Any AE
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), and Adverse Event of Special Interest (AESI)
Any SAE
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), and Adverse Event of Special Interest (AESI)
Any AESI
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 17 daysPopulation: The analysis was performed on the Safety Analysis Set that included all participants who received study intervention.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAEs are defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in a participant's offspring; abnormal pregnancy outcomes; is a suspected transmission of any infectious agent via an authorized medicinal product; or other situations as per medical and scientific judgement of the Investigator. AESIs are AEs of scientific interest specific to the drug class. AESIs for this study include the following but not limited to taste disturbance (dysgeusia, hypogeusia, ageusia), oral paresthesia and oral hypoesthesia. Number of participants with any AE, SAE, or AESI were reported.
Outcome measures
| Measure |
Part 1: Moderate HI Participants
n=8 Participants
Participants with moderate HI received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
Part 1: Matched Healthy Participants to Moderate HI
n=8 Participants
Healthy participants (matched to participants with moderate HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
|---|---|---|
|
Part 2: Number of Participants With Any AE, SAE, and AESI
Any AE
|
2 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Any AE, SAE, and AESI
Any SAE
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Any AE, SAE, and AESI
Any AESI
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 5Population: The analysis was performed on the Safety Analysis Set that included all participants who received study intervention.
Blood samples were collected to analyze clinical chemical parameters: blood urea nitrogen (BUN)/urea, potassium, creatinine, sodium, calcium, glucose \[fasting/non-fasting\], creatine phosphokinase (CPK), serum albumin concentration, serum alpha-1-glycoprotein concentration, aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT), alkaline phosphatase, total bilirubin, direct bilirubin, indirect bilirubin and total protein. Number of participants with clinically significant changes in clinical chemistry parameters has been reported. Clinical significance was determined by the Investigator.
Outcome measures
| Measure |
Part 1: Moderate HI Participants
n=8 Participants
Participants with moderate HI received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
Part 1: Matched Healthy Participants to Moderate HI
n=8 Participants
Healthy participants (matched to participants with moderate HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
|---|---|---|
|
Part 1: Number of Participants With Clinically Significant Changes in Clinical Chemistry Parameters
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 5Population: The analysis was performed on the Safety Analysis Set that included all participants who received study intervention.
Blood samples were collected to analyze clinical chemical parameters: BUN/urea, potassium, creatinine, sodium, calcium, glucose \[fasting/non-fasting\], CPK, serum albumin concentration, serum alpha-1-glycoprotein concentration, AST/SGOT, ALT/SGPT, alkaline phosphatase, total bilirubin, direct bilirubin, indirect bilirubin and total protein. Number of participants with clinically significant changes in clinical chemistry parameters has been reported. Clinical significance was determined by the Investigator.
Outcome measures
| Measure |
Part 1: Moderate HI Participants
n=8 Participants
Participants with moderate HI received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
Part 1: Matched Healthy Participants to Moderate HI
n=8 Participants
Healthy participants (matched to participants with moderate HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
|---|---|---|
|
Part 2: Number of Participants With Clinically Significant Changes in Clinical Chemistry Parameters
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 5Population: The analysis was performed on the Safety Analysis Set that included all participants who received study intervention.
Blood samples were collected to analyze hematology parameters: platelet count, red blood cell (RBC) count, RBC indices (mean corpuscular volume \[MCV\], mean corpuscular hemoglobin \[MCH\], percent reticulocytes), white blood cell (WBC) count with differential (neutrophils, lymphocytes, monocytes, eosinophil, basophils), hemoglobin, and hematocrit. Number of participants with clinically significant changes in hematology parameters has been reported. Clinical significance was determined by the Investigator.
Outcome measures
| Measure |
Part 1: Moderate HI Participants
n=8 Participants
Participants with moderate HI received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
Part 1: Matched Healthy Participants to Moderate HI
n=8 Participants
Healthy participants (matched to participants with moderate HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
|---|---|---|
|
Part 1: Number of Participants With Clinically Significant Changes in Hematology Parameters
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 5Population: The analysis was performed on the Safety Analysis Set that included all participants who received study intervention.
Blood samples were collected to analyze hematology parameters: platelet count, RBC count, RBC indices (MCV, MCH, percent reticulocytes), WBC count with differential (neutrophils, lymphocytes, monocytes, eosinophil, basophils), hemoglobin, and hematocrit. Number of participants with clinically significant changes in hematology parameters has been reported. Clinical significance was determined by the Investigator.
Outcome measures
| Measure |
Part 1: Moderate HI Participants
n=8 Participants
Participants with moderate HI received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
Part 1: Matched Healthy Participants to Moderate HI
n=8 Participants
Healthy participants (matched to participants with moderate HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
|---|---|---|
|
Part 2: Number of Participants With Clinically Significant Changes in Hematology Parameters
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 5Population: The analysis was performed on the Safety Analysis Set that included all participants who received study intervention.
Urine samples were collected to analyze urinalysis parameters: specific gravity; and potential of hydrogen (pH), glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase which were analyzed by dipstick. Number of participants with clinically significant changes in urinalysis parameters has been reported. Clinical significance was determined by the Investigator.
Outcome measures
| Measure |
Part 1: Moderate HI Participants
n=8 Participants
Participants with moderate HI received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
Part 1: Matched Healthy Participants to Moderate HI
n=8 Participants
Healthy participants (matched to participants with moderate HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
|---|---|---|
|
Part 1: Number of Participants With Clinically Significant Changes in Urinalysis
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 5Population: The analysis was performed on the Safety Analysis Set that included all participants who received study intervention.
Urine samples were collected to analyze urinalysis parameters: specific gravity; and pH, glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase which were analyzed by dipstick. Number of participants with clinically significant changes in urinalysis parameters has been reported. Clinical significance was determined by the Investigator.
Outcome measures
| Measure |
Part 1: Moderate HI Participants
n=8 Participants
Participants with moderate HI received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
Part 1: Matched Healthy Participants to Moderate HI
n=8 Participants
Healthy participants (matched to participants with moderate HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
|---|---|---|
|
Part 2: Number of Participants With Clinically Significant Changes in Urinalysis
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 5Population: The analysis was performed on the Safety Analysis Set that included all participants who received study intervention.
Vital signs including systolic and diastolic blood pressure, pulse rate, respiratory rate, and temperature were measured. Blood pressure and pulse rate measurements were performed with participants in a seated position for at least 5 minutes, except when they were supine or semi-reclined because of study procedures and/or AEs (such as nausea, dizziness). Number of participants with abnormal clinically significant changes in vital signs has been reported. Clinical significance was determined by the Investigator.
Outcome measures
| Measure |
Part 1: Moderate HI Participants
n=8 Participants
Participants with moderate HI received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
Part 1: Matched Healthy Participants to Moderate HI
n=8 Participants
Healthy participants (matched to participants with moderate HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
|---|---|---|
|
Part 1: Number of Participants With Clinically Significant Changes in Vital Signs
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 5Population: The analysis was performed on the Safety Analysis Set that included all participants who received study intervention.
Vital signs including systolic and diastolic blood pressure, pulse rate, respiratory rate, and temperature were measured. Blood pressure and pulse rate measurements were performed with participants in a seated position for at least 5 minutes, except when they were supine or semi-reclined because of study procedures and/or AEs (such as nausea, dizziness). Number of participants with abnormal clinically significant changes in vital signs has been reported. Clinical significance was determined by the Investigator.
Outcome measures
| Measure |
Part 1: Moderate HI Participants
n=8 Participants
Participants with moderate HI received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
Part 1: Matched Healthy Participants to Moderate HI
n=8 Participants
Healthy participants (matched to participants with moderate HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
|---|---|---|
|
Part 2: Number of Participants With Clinically Significant Changes in Vital Signs
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 5Population: The analysis was performed on the Safety Analysis Set that included all participants who received study intervention.
ECG values included measurements of heart rate, PR interval, QRS interval, uncorrected QT interval, and corrected QT interval using Fridericia formula (QTcF). 12-lead ECG was recorded with the participant in a supine position for at least 5 minutes. Number of participants with clinically significant 12-lead ECG findings has been reported. Clinical significance was determined by the Investigator.
Outcome measures
| Measure |
Part 1: Moderate HI Participants
n=8 Participants
Participants with moderate HI received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
Part 1: Matched Healthy Participants to Moderate HI
n=8 Participants
Healthy participants (matched to participants with moderate HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
|---|---|---|
|
Part 1: Number of Participants With Clinically Significant Changes in 12 Lead Electrocardiogram (ECG) Findings
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 5Population: The analysis was performed on the Safety Analysis Set that included all participants who received study intervention.
ECG values included measurements of heart rate, PR interval, QRS interval, uncorrected QT interval, and QTcF. 12-lead ECG was recorded with the participant in a supine position for at least 5 minutes. Number of participants with clinically significant 12-lead ECG findings has been reported. Clinical significance was determined by the Investigator.
Outcome measures
| Measure |
Part 1: Moderate HI Participants
n=8 Participants
Participants with moderate HI received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
Part 1: Matched Healthy Participants to Moderate HI
n=8 Participants
Healthy participants (matched to participants with moderate HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
|---|---|---|
|
Part 2: Number of Participants With Clinically Significant Changes in 12 Lead ECG Findings
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dosePopulation: The analysis was performed on the PK Analysis Set that included all participants who received study intervention and who had at least 1 non-missing PK assessment (NQ values were considered as non-missing values).
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: Moderate HI Participants
n=8 Participants
Participants with moderate HI received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
Part 1: Matched Healthy Participants to Moderate HI
n=8 Participants
Healthy participants (matched to participants with moderate HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
|---|---|---|
|
Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Camlipixant
|
0.750 Hours
Interval 0.25 to 2.5
|
1.000 Hours
Interval 0.5 to 2.5
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dosePopulation: The analysis was performed on the PK Analysis Set that included all participants who received study intervention and who had at least 1 non-missing PK assessment (NQ values were considered as non-missing values).
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: Moderate HI Participants
n=8 Participants
Participants with moderate HI received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
Part 1: Matched Healthy Participants to Moderate HI
n=8 Participants
Healthy participants (matched to participants with moderate HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
|---|---|---|
|
Part 2: Tmax of Camlipixant
|
0.750 Hours
Interval 0.25 to 2.5
|
0.875 Hours
Interval 0.47 to 2.5
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dosePopulation: The analysis was performed on the PK Analysis Set that included all participants who received study intervention and who had at least 1 non-missing PK assessment (NQ values were considered as non-missing values).
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: Moderate HI Participants
n=8 Participants
Participants with moderate HI received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
Part 1: Matched Healthy Participants to Moderate HI
n=8 Participants
Healthy participants (matched to participants with moderate HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
|---|---|---|
|
Part 1: Terminal Elimination Half-life (T1/2) Following Administration of Camlipixant
|
6.101 Hours
Geometric Coefficient of Variation 46.8
|
5.809 Hours
Geometric Coefficient of Variation 14.4
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dosePopulation: The analysis was performed on the PK Analysis Set that included all participants who received study intervention and who had at least 1 non-missing PK assessment (NQ values were considered as non-missing values).
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: Moderate HI Participants
n=8 Participants
Participants with moderate HI received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
Part 1: Matched Healthy Participants to Moderate HI
n=8 Participants
Healthy participants (matched to participants with moderate HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
|---|---|---|
|
Part 2: T1/2 Following Administration of Camlipixant
|
6.626 Hours
Geometric Coefficient of Variation 17.1
|
7.855 Hours
Geometric Coefficient of Variation 56.3
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dosePopulation: The analysis was performed on the PK Analysis Set that included all participants who received study intervention and who had at least 1 non-missing PK assessment (NQ values were considered as non-missing values).
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: Moderate HI Participants
n=8 Participants
Participants with moderate HI received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
Part 1: Matched Healthy Participants to Moderate HI
n=8 Participants
Healthy participants (matched to participants with moderate HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
|---|---|---|
|
Part 1: Apparent Oral Clearance (CL/F) of Camlipixant
|
8.605 Liters per hour
Geometric Coefficient of Variation 22.7
|
10.56 Liters per hour
Geometric Coefficient of Variation 19.0
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dosePopulation: The analysis was performed on the PK Analysis Set that included all participants who received study intervention and who had at least 1 non-missing PK assessment (NQ values were considered as non-missing values).
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: Moderate HI Participants
n=8 Participants
Participants with moderate HI received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
Part 1: Matched Healthy Participants to Moderate HI
n=8 Participants
Healthy participants (matched to participants with moderate HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
|---|---|---|
|
Part 2: CL/F of Camlipixant
|
6.388 Liters per hour
Geometric Coefficient of Variation 39.9
|
10.73 Liters per hour
Geometric Coefficient of Variation 46.9
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dosePopulation: The analysis was performed on the PK Analysis Set that included all participants who received study intervention and who had at least 1 non-missing PK assessment (NQ values were considered as non-missing values).
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: Moderate HI Participants
n=8 Participants
Participants with moderate HI received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
Part 1: Matched Healthy Participants to Moderate HI
n=8 Participants
Healthy participants (matched to participants with moderate HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
|---|---|---|
|
Part 1: Apparent Oral Volume of Distribution (Vz/F) of Camlipixant
|
75.74 Liters
Geometric Coefficient of Variation 36.3
|
88.49 Liters
Geometric Coefficient of Variation 20.4
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dosePopulation: The analysis was performed on the PK Analysis Set that included all participants who received study intervention and who had at least 1 non-missing PK assessment (NQ values were considered as non-missing values).
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: Moderate HI Participants
n=8 Participants
Participants with moderate HI received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
Part 1: Matched Healthy Participants to Moderate HI
n=8 Participants
Healthy participants (matched to participants with moderate HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
|---|---|---|
|
Part 2: Vz/F of Camlipixant
|
61.06 Liters
Geometric Coefficient of Variation 32.5
|
121.6 Liters
Geometric Coefficient of Variation 42.5
|
Adverse Events
Part 1: Moderate HI Participants
Part 1: Matched Healthy Participants to Moderate HI
Part 2: Severe HI Participants
Part 2: Matched Healthy Participants to Severe HI
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1: Moderate HI Participants
n=8 participants at risk
Participants with moderate HI received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
Part 1: Matched Healthy Participants to Moderate HI
n=8 participants at risk
Healthy participants (matched to participants with moderate HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
Part 2: Severe HI Participants
n=8 participants at risk
Participants with severe HI received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
Part 2: Matched Healthy Participants to Severe HI
n=8 participants at risk
Healthy participants (matched to participants with severe HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • All-cause mortality, SAEs, and non-SAEs were collected up to 17 days for both Part 1 and Part 2
Safety Analysis Set included all participants who received study intervention.
|
0.00%
0/8 • All-cause mortality, SAEs, and non-SAEs were collected up to 17 days for both Part 1 and Part 2
Safety Analysis Set included all participants who received study intervention.
|
25.0%
2/8 • Number of events 2 • All-cause mortality, SAEs, and non-SAEs were collected up to 17 days for both Part 1 and Part 2
Safety Analysis Set included all participants who received study intervention.
|
0.00%
0/8 • All-cause mortality, SAEs, and non-SAEs were collected up to 17 days for both Part 1 and Part 2
Safety Analysis Set included all participants who received study intervention.
|
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