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

NCT06222892 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 221852
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Cough

Keywords

Camlipixant; Healthy participants; Hepatic Impairment; Pharmacokinetic; Safety

Outcome Measures

Primary Outcomes (4)

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

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

  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

• Part 2: AUC(0-inf) of Camlipixant

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

  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

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

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

  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

• Part 2: Cmax of Camlipixant

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

  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

Secondary Outcomes (20)

• Part 1: Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), and Adverse Event of Special Interest (AESI)

  Up to 17 days

• Part 2: Number of Participants With Any AE, SAE, and AESI

  Up to 17 days

• Part 1: Number of Participants With Clinically Significant Changes in Clinical Chemistry Parameters

  Up to Day 5

• Part 2: Number of Participants With Clinically Significant Changes in Clinical Chemistry Parameters

  Up to Day 5

• Part 1: Number of Participants With Clinically Significant Changes in Hematology Parameters

  Up to Day 5

Study Arms (4)

Part 1: Moderate HI Participants

EXPERIMENTAL

Participants with moderate HI received a single dose of camlipixant 50 milligrams (mg) tablet orally on Day 1 in the fasted state.

Drug: Camlipixant

Part 1: Matched Healthy Participants to Moderate HI

EXPERIMENTAL

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.

Drug: Camlipixant

Part 2: Severe HI Participants

EXPERIMENTAL

Participants with severe HI received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state.

Drug: Camlipixant

Part 2: Matched Healthy Participants to Severe HI

EXPERIMENTAL

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.

Drug: Camlipixant

Interventions

Camlipixant DRUG

Camlipixant was administered.

Part 1: Matched Healthy Participants to Moderate HI; Part 1: Moderate HI Participants; Part 2: Matched Healthy Participants to Severe HI; Part 2: Severe HI Participants

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male or female participant, greater than or equals to (\>=) 18 years and less than or equals to (\<=) 75 years of age at the screening visit.
• Male and female participants must follow protocol-specified contraception guidance.
• Guidance for Female Participants
• a. Female participants of childbearing potential must agree to one of the following methods of contraception: i. Hysteroscopic sterilization or bilateral tubal ligation at least 6 months prior to dosing.
• ii. Non-hormonal releasing intrauterine device (IUD) or hormonal contraceptives (e.g., oral, IUD, vaginal ring, transdermal patch, depot, implantable, etc.) for at least 3 months prior to dosing and with either a physical (e.g., condom, diaphragm, or other) or a chemical (e.g., spermicide) barrier method from the time of the screening visit.
• b. In addition, female participants of childbearing potential will be advised to keep the same birth control method for at least 30 days after dosing.
• c. Female participant must agree not to donate ova from dosing until at least 30 days after dosing.
• Guidance for male participants. a. Male participants who are not vasectomized for at least 4 months prior to dosing and who are sexually active with a female partner of childbearing potential must be willing to use one of the following acceptable contraceptive methods from dosing until 90 days after dosing.
• i. Simultaneous use of condom and hormonal contraceptive (e.g., oral, IUD, vaginal ring, patch, depot, implantable, etc.) or non-hormonal intrauterine device used for at least 3 months prior to dosing for the female partner.
• ii. Simultaneous use of condom and a diaphragm or cervical cap with spermicide for the female partner.
• b. No restrictions are required for a vasectomized male provided his vasectomy has been performed 4 months or more prior to dosing. A male who has been vasectomized less than 4 months prior to dosing must follow the same restrictions as a non-vasectomized male.
• Female Participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: Is a woman of non-childbearing potential (WONCBP) OR Is a Woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of \<1 percent (%), during the study intervention period and for at least 14 days after the last dose of study intervention. The investigator should evaluate potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of study intervention.
• A WOCBP must have a negative highly sensitive pregnancy test urine or serum as required by local regulations) within specify timeframe before the first dose of study intervention. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
• Participants must weigh at least 50 kilogram (kg) and have a Body mass index (BMI) \>= 18.0 and \<= 40.0 kilograms per square meter (kg/m\^2), at the screening visit.
• Continuous non-smoker who has not used nicotine- and tobacco-containing products or light smoker (\<= 5 cigarettes/day or the equivalent) for the last 3 months prior to study screening.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Bellus Health Inc. - a GSK company: lead

Study Sites (3)

GSK Investigational Site

Miami, Florida, 33136, United States

Location

GSK Investigational Site

Orlando, Florida, 32809, United States

Location

GSK Investigational Site

San Antonio, Texas, 78215, United States

Location

MeSH Terms

Conditions

Cough

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This will be an open-label study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: January 25, 2024
• Study Start: February 2, 2024
• Primary Completion: December 17, 2024
• Study Completion: December 30, 2024
• Last Updated: January 7, 2026
• Results First Posted: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

US (3)