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

A Phase 1, Open-label Study to Investigate the Pharmacokinetics and Safety of Camlipixant in Male and Female Participants Aged 18-75 Years of Age With Hepatic Impairment Compared to Matched Healthy Participants With Normal Hepatic Function

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

Study Overview

• Status: Recruiting
• Conditions: Cough
• Intervention / Treatment: Drug: Camlipixant

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: US GSK Clinical Trials Call Center; Phone Number: 877-379-3718; Email: GSKClinicalSupportHD@gsk.com
• Study Contact Backup: Name: EU GSK Clinical Trials Call Center; Phone Number: +44 (0) 20 89904466; Email: GSKClinicalSupportHD@gsk.com

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • GSK Investigational Site
      • Contact: US GSK Clinical Trials Call Center; Phone Number: 877-379-3718; Email: GSKClinicalSupportHD@gsk.com
      • Contact: EU GSK Clinical Trials Call Centre; Phone Number: +44 (0) 20 8990 4466; Email: GSKClinicalSupportHD@gsk.com
      • Principal Investigator: Richard Preston
    • Orlando, Florida, United States, 32809
      • Recruiting
      • GSK Investigational Site
      • Contact: US GSK Clinical Trials Call Center; Phone Number: 877-379-3718; Email: GSKClinicalSupportHD@gsk.com
      • Contact: EU GSK Clinical Trials Call Centre; Phone Number: +44 (0) 20 8990 4466; Email: GSKClinicalSupportHD@gsk.com
      • Principal Investigator: Thomas C. Marbury
  • Texas
    • San Antonio, Texas, United States, 78215
      • Recruiting
      • GSK Investigational Site
      • Principal Investigator: Eric J Lawitz
      • Contact: US GSK Clinical Trials Call Center; Phone Number: 877-379-3718; Email: GSKClinicalSupportHD@gsk.com
      • Contact: EU GSK Clinical Trials Call Centre; Phone Number: +44 (0) 20 8990 4466; Email: GSKClinicalSupportHD@gsk.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 (<=) 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.

1. 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.
2. 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.

3. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.

   • 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.
   • Participant who understands the study procedures in the informed consent form (ICF) and is willing and able to comply with the protocol.

Additional inclusion criteria for hepatic impaired participants.

• Participants aside from HI, be sufficiently healthy for study participation based upon medical history, physical examination, vital signs, ECGs, and screening clinical laboratory profiles, as deemed by the Principal Investigator (PI) or designee, including the following:

  1. Seated blood pressure is >= 90/40 millimeters of mercury (mmHg) and <= 160/100 mmHg at the screening visit.
  2. Seated heart rate is >= 40 beats per minute (bpm) and <= 99 bpm at the screening visit.
  3. Corrected value of the interval between the Q and T waves on the electrocardiogram tracing, corrected QT interval using Fridericia formula (QTcF) is <= 480 milliseconds (msec) and has ECG findings considered normal or not clinically significant by the PI or designee at the screening visit.
  4. Estimated creatinine clearance >= 80 milliliters per minute (mL/min) at the screening visit.
  5. Total bilirubin <= 6 milligrams per deciliters (mg/dL).

• Has a score on the Child-Pugh scale at the screening visit as follows:

  a. Severe HI: >= 10 and <= 15; or Moderate HI: >= 7 and <= 9; or Mild HI: >= 5 and <= 6.

• Participant has stable HI as defined by a diagnosis of chronic (>= 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:

  1. Seated blood pressure is >= 90/40 mmHg and <= 140/90 mmHg at the screening visit.
  2. Seated heart rate is >= 40 bpm and <= 99 bpm at the screening visit.
  3. QTcF interval is <= 450 msec and has ECG findings considered normal or not clinically significant by the PI or designee at the screening visit.
  4. 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 positive polymerase chain reaction test 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.
• Female participant with a positive pregnancy test at the screening visit or at check-in or who is lactating.
• 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).
• Participant has been on a diet incompatible with the on study diet, in the opinion of the PI or designee, within the 30 days prior to dosing.
• Donation of blood or plasma greater than 400 mL within the last 90 days prior to dosing.
• Donation of bone marrow within the last 6 months prior to dosing.

Additional exclusion criteria for hepatic impaired participants:

• Participant with history or presence of clinically significant medical or psychiatric condition or disease (aside from HI) in the opinion of the PI or designee and Sponsor medical representative.

Additional exclusion criteria for healthy control participants:

• Participant with history or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee and Sponsor medical representative.
• Participant with history or presence of alcoholism or drug abuse within the past 2 years prior to dosing.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Participants with moderate hepatic impairment receiving Camlipixant; Participants with moderate hepatic impairment will receive Camlipixant	Drug: Camlipixant; Camlipixant will be administered.
Experimental: Part 1: Healthy participants (matched to moderate hepatic impairment) receiving Camlipixant; Healthy participants (matched to moderate hepatic impairment) will receive Camlipixant	Drug: Camlipixant; Camlipixant will be administered.
Experimental: Part 2: Participants with mild hepatic impairment receiving Camlipixant; Participants with mild hepatic impairment will receive Camlipixant	Drug: Camlipixant; Camlipixant will be administered.
Experimental: Part 2: Participants with severe hepatic impairment receiving Camlipixant; Participants with severe hepatic impairment will receive Camlipixant	Drug: Camlipixant; Camlipixant will be administered.
Experimental: Part 2:Healthy participants(matched to mild and/or severe hepatic impairment)receiving Camlipixant; Healthy participants(matched to mild and/or severe hepatic impairment)will receive Camlipixant	Drug: Camlipixant; Camlipixant will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Concentration-time curve from time zero to Infinity (AUC[0 to infinity]) of Camlipixant	Click here to enter text.	Up to 96 hours post-dose
Maximum observed plasma concentration (Cmax) of Camlipixant	Click here to enter text.	Up to 96 hours post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With any Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESI)	Click here to enter text.	Up to 2 weeks
Number of participants with clinically significant changes in laboratory parameters, vital signs, and 12 lead electrocardiogram (ECG) findings	Click here to enter text.	Up to 2 weeks
Time of occurrence of Cmax (Tmax) of Camlipixant	Click here to enter text.	Up to 96 hours post-dose
Half-life (t1/2) of Camlipixant	Click here to enter text.	Up to 96 hours post-dose
Apparent oral clearance (CL/F) of Camlipixant	Click here to enter text.	Up to 96 hours post-dose
Apparent oral volume of distribution (Vz/F) of Camlipixant	Click here to enter text.	Up to 96 hours post-dose

Collaborators and Investigators

• Sponsor: Bellus Health Inc. - a GSK company

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2024
• Primary Completion (Estimated): July 25, 2024
• Study Completion (Estimated): January 15, 2025

Study Registration Dates

• First Submitted: January 16, 2024
• First Submitted That Met QC Criteria: January 16, 2024
• First Posted (Actual): January 25, 2024

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Safety; Healthy participants; Pharmacokinetic; Hepatic Impairment; Camlipixant
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: 221852

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No