Phase 1
N=16
A Study of Camlipixant in Male and Female Healthy Participants and Participants With Hepatic Impairment Aged 18-75 Years of Age
Cough
Bottom Line
View on ClinicalTrials.gov: NCT06222892 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Part 1: Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0-inf]) of Camlipixant — 5811; 4735 Hours*nanograms per milliliter
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Camlipixant (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bellus Health Inc. - a GSK company
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 1: Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0-inf]) of Camlipixant |
5811; 4735 | — |
| PRIMARY Part 2: AUC(0-inf) of Camlipixant |
7827; 4662 | — |
| PRIMARY Part 1: Maximum Observed Plasma Concentration (Cmax) of Camlipixant |
1317; 960.0 | — |
| PRIMARY Part 2: Cmax of Camlipixant |
1228; 985.8 | — |
| SECONDARY Part 1: Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), and Adverse Event of Special Interest (AESI) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Part 2: Number of Participants With Any AE, SAE, and AESI |
2; 0; 0; 0; 0; 0 | — |
| SECONDARY Part 1: Number of Participants With Clinically Significant Changes in Clinical Chemistry Parameters |
0; 0 | — |
| SECONDARY Part 2: Number of Participants With Clinically Significant Changes in Clinical Chemistry Parameters |
0; 0 | — |
| SECONDARY Part 1: Number of Participants With Clinically Significant Changes in Hematology Parameters |
0; 0 | — |
| SECONDARY Part 2: Number of Participants With Clinically Significant Changes in Hematology Parameters |
0; 0 | — |
| SECONDARY Part 1: Number of Participants With Clinically Significant Changes in Urinalysis |
0; 0 | — |
| SECONDARY Part 2: Number of Participants With Clinically Significant Changes in Urinalysis |
0; 0 | — |
| SECONDARY Part 1: Number of Participants With Clinically Significant Changes in Vital Signs |
0; 0 | — |
| SECONDARY Part 2: Number of Participants With Clinically Significant Changes in Vital Signs |
0; 0 | — |
| SECONDARY Part 1: Number of Participants With Clinically Significant Changes in 12 Lead Electrocardiogram (ECG) Findings |
0; 0 | — |
| SECONDARY Part 2: Number of Participants With Clinically Significant Changes in 12 Lead ECG Findings |
0; 0 | — |
| SECONDARY Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Camlipixant |
0.750; 1.000 | — |
| SECONDARY Part 2: Tmax of Camlipixant |
0.750; 0.875 | — |
| SECONDARY Part 1: Terminal Elimination Half-life (T1/2) Following Administration of Camlipixant |
6.101; 5.809 | — |
| SECONDARY Part 2: T1/2 Following Administration of Camlipixant |
6.626; 7.855 | — |
| SECONDARY Part 1: Apparent Oral Clearance (CL/F) of Camlipixant |
8.605; 10.56 | — |
| SECONDARY Part 2: CL/F of Camlipixant |
6.388; 10.73 | — |
| SECONDARY Part 1: Apparent Oral Volume of Distribution (Vz/F) of Camlipixant |
75.74; 88.49 | — |
| SECONDARY Part 2: Vz/F of Camlipixant |
61.06; 121.6 | — |
Summary
The purpose of this study is to assess the effect of Hepatic impairment (HI) on the Pharmacokinetic (PK) profile and safety of Camlipixant.
Eligibility Criteria
Inclusion Criteria
Inclusion criteria for all participants
- Adult male or female participant, greater than or equals to (>=) 18 years and less than or equals to ( = 18.0 and = 90/40 millimeters of mercury (mmHg) and = 40 beats per minute (bpm) and = 80 milliliters per minute (mL/min) at the screening visit.
- Total bilirubin = 10 and = 7 and = 5 and = 6 months), stable (no acute episodes of illness within 30 days prior to dosing due to deterioration in hepatic function) hepatic insufficiency with features of cirrhosis due to any etiology.
Additional inclusion criteria for healthy control participants:
- Medically healthy participants with no clinically significant medical history, physical examination, screening clinical laboratory profiles, vital signs and ECGs, as deemed by the PI or designee, including the following:
- Seated blood pressure is >= 90/40 mmHg and = 40 bpm and <= 99 bpm at the screening visit.
- QTcF interval is <= 450 msec and has ECG findings considered normal or not clinically significant by the PI or designee at the screening visit.
- QTc <= 480 msec in participants with bundle branch block.
- Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), direct bilirubin, indirect bilirubin, and total bilirubin within normal ranges at the screening visit and check-in. Only abnormal values up to 1.5 times upper limit of normal may be repeated once.
Exclusion Criteria
Exclusion criteria for all participants:
- Mentally or legally incapacitated participants or has significant emotional problems at the time of the screening visit or are expected during the conduct of the study.
- Participants with surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the participant's safety in case of participation in the study.
- Participants with history or presence of liver or other solid organ transplant.
- Participants with history of acute pancreatitis within 1 year of study entry.
- Participant with history or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds.
- Participant who has received any Coronavirus Disease-2019 (COVID-19) vaccine within 14 days prior to dosing.
- Participant who is unable to refrain from or anticipates the use of prohibited prescription or non-prescription medication, herbal remedies, or supplements.
- Participant with history or presence of drug abuse within the past 6 months prior to dosing. Positive drug screen due to prescription drug use in hepatic impaired participants will be allowed if approved by PI on a case by case basis.
- Participation in another clinical study within 30 days (or 5 half-lives, whichever is longer) prior to dosing. The 30 day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of the current study.
- Participants with positive pre-study drug/alcohol screen, including tetrahydrocannabinol (THC) at the screening visit or at check-in, unless the positive drug test is due to prescription drug use that is approved by the PI or designee and sponsor.
- Participants with positive results for Human immunodeficiency virus (HIV).
- Participants has positive coronavirus Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) rapid test and/or positive polymerase chain reaction test (based on local procedures) at check-in.
- Participants with presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) at screening or within 3 months prior to first dose of study intervention.
- Participants with positive hepatitis C antibody test result at screening or within 3 months prior to starting study intervention.
- Participants with unhealthy alcohol use, defined as use more than 24 grams (g) pure alcohol per day for male and 12 g for female (12 g equals to approximately 300 milliliters [mL] beer, 100 mL wine, or 25 mL spirits
Data sourced from ClinicalTrials.gov (NCT06222892). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.