NCT06222892

A Study of Camlipixant in Male and Female Healthy Participants and Participants With Hepatic Impairment Aged 18-75 Years of Age

Completed Phase 1 Results posted Last updated 7 January 2026

What this trial tests

Phase 1 trial testing Camlipixant in Cough in 32 participants. Completed in 30 December 2024.

Timeline

2 February 2024

Primary endpoint
17 December 2024

30 December 2024

Quick facts

Lead sponsor	Bellus Health Inc. - a GSK company
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	32
Start date	2 February 2024
Primary completion	17 December 2024
Estimated completion	30 December 2024
Sites	3 locations across United States

Drugs / interventions tested

• Camlipixant — full drug profile →

Conditions studied

• Cough — all drugs for Cough →

Sponsor

Bellus Health Inc. - a GSK company — full company profile →

Who can join

Adults 18 to 75, any sex, with Cough. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Part 1: Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0-inf]) of Camlipixant Primary · 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

Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of camlipixant. PK analysis was conducted using standard non-compartmental methods.

Group	Value	95% CI
Part 1: Moderate HI Participants	5811	± 22.7
Part 1: Matched Healthy Participants to Moderate HI	4735	± 19.0

Part 2: AUC(0-inf) of Camlipixant Primary · 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

Blood samples were collected at indicated time points for PK analysis of camlipixant. PK analysis was conducted using standard non-compartmental methods.

Group	Value	95% CI
Part 2: Severe HI Participants	7827	± 39.9
Part 2: Matched Healthy Participants to Severe HI	4662	± 46.9

Part 1: Maximum Observed Plasma Concentration (Cmax) of Camlipixant Primary · 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

Blood samples were collected at indicated time points for PK analysis of camlipixant. PK analysis was conducted using standard non-compartmental methods.

Group	Value	95% CI
Part 1: Moderate HI Participants	1317	± 33.5
Part 1: Matched Healthy Participants to Moderate HI	960.0	± 30.7

Part 2: Cmax of Camlipixant Primary · 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

Blood samples were collected at indicated time points for PK analysis of camlipixant. PK analysis was conducted using standard non-compartmental methods.

Group	Value	95% CI
Part 2: Severe HI Participants	1228	± 38.9
Part 2: Matched Healthy Participants to Severe HI	985.8	± 29.8

Part 1: Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), and Adverse Event of Special Interest (AESI) Secondary · Up to 17 days

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

Any AE

Group	Value	95% CI
Part 1: Moderate HI Participants	0
Part 1: Matched Healthy Participants to Moderate HI	0

Any SAE

Group	Value	95% CI
Part 1: Moderate HI Participants	0
Part 1: Matched Healthy Participants to Moderate HI	0

Any AESI

Group	Value	95% CI
Part 1: Moderate HI Participants	0
Part 1: Matched Healthy Participants to Moderate HI	0

Part 2: Number of Participants With Any AE, SAE, and AESI Secondary · Up to 17 days

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

Any AE

Group	Value	95% CI
Part 2: Severe HI Participants	2
Part 2: Matched Healthy Participants to Severe HI	0

Any SAE

Group	Value	95% CI
Part 2: Severe HI Participants	0
Part 2: Matched Healthy Participants to Severe HI	0

Any AESI

Group	Value	95% CI
Part 2: Severe HI Participants	0
Part 2: Matched Healthy Participants to Severe HI	0

Part 1: Number of Participants With Clinically Significant Changes in Clinical Chemistry Parameters Secondary · Up to Day 5

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 ch

Group	Value	95% CI
Part 1: Moderate HI Participants	0
Part 1: Matched Healthy Participants to Moderate HI	0

Part 2: Number of Participants With Clinically Significant Changes in Clinical Chemistry Parameters Secondary · Up to Day 5

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.

Group	Value	95% CI
Part 2: Severe HI Participants	0
Part 2: Matched Healthy Participants to Severe HI	0

Part 1: Number of Participants With Clinically Significant Changes in Hematology Parameters Secondary · Up to Day 5

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.

Group	Value	95% CI
Part 1: Moderate HI Participants	0
Part 1: Matched Healthy Participants to Moderate HI	0

Part 2: Number of Participants With Clinically Significant Changes in Hematology Parameters Secondary · Up to Day 5

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.

Group	Value	95% CI
Part 2: Severe HI Participants	0
Part 2: Matched Healthy Participants to Severe HI	0

Part 1: Number of Participants With Clinically Significant Changes in Urinalysis Secondary · Up to Day 5

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.

Group	Value	95% CI
Part 1: Moderate HI Participants	0
Part 1: Matched Healthy Participants to Moderate HI	0

Part 2: Number of Participants With Clinically Significant Changes in Urinalysis Secondary · Up to Day 5

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.

Group	Value	95% CI
Part 2: Severe HI Participants	0
Part 2: Matched Healthy Participants to Severe HI	0

Adverse events — posted to ClinicalTrials.gov

Time frame: All-cause mortality, SAEs, and non-SAEs were collected up to 17 days for both Part 1 and Part 2. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part 1: Moderate HI Participants

Serious: 0/8 (0%)

Deaths: 0/8

Part 1: Matched Healthy Participants to Moderate HI

Serious: 0/8 (0%)

Deaths: 0/8

Part 2: Severe HI Participants

Serious: 0/8 (0%)

Deaths: 0/8

Part 2: Matched Healthy Participants to Severe HI

Serious: 0/8 (0%)

Deaths: 0/8

Other adverse events (1 terms — click to expand)

Reaction	System	Part 1: Moderate HI Partic…	Part 1: Matched Healthy Pa…	Part 2: Severe HI Particip…	Part 2: Matched Healthy Pa…
Diarrhoea	Gastrointestinal disorders	—	—	—	—

Data from ClinicalTrials.gov NCT06222892 adverse events section.

Sponsor's own description

The purpose of this study is to assess the effect of Hepatic impairment (HI) on the Pharmacokinetic (PK) profile and safety of Camlipixant.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.