Completed

Food Effect on Camlipixant Pharmacokinetics in Healthy Participants

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Study Aim

This study aims to evaluate how food consumption affects the body's absorption and processing of the drug Camlipixant in healthy volunteers.

What is being tested

GSK5464714- Camlipixant

Drug
Who is being recruted

Cough+3

+ Respiration Disorders

+ Respiratory Tract Diseases

From 18 to 55 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: July 2024
See protocol details

Summary

Principal SponsorBellus Health Inc. - a GSK company
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 9, 2024

Actual date on which the first participant was enrolled.

This clinical trial aims to understand how food affects the way the body absorbs and processes a medication called Camlipixant (GSK5464714). The study targets healthy men and women to gather initial insights into the drug's behavior in the body. Understanding the influence of food is important as it can affect the effectiveness and safety of the medication. This information is crucial for developing guidelines on how the medication should be taken with respect to meals. Participants in the study will receive a single dose of Camlipixant and will be assigned to different sequences to compare the effects with and without food. The study uses an open-label design, meaning both the researchers and participants know what treatment is being administered. There will be a minimum of a 7-day break between each treatment period to ensure that the drug is fully cleared from the body before the next sequence. This study helps gather foundational data that could lead to better dosing recommendations for future patients.

Official TitleA Phase 1, Single Center, Single Dose, Open-Label, Randomized, 2-Way Crossover Study to Investigate the Food Effect on the Pharmacokinetics of Camlipixant in Healthy Male and Female Participants
Principal SponsorBellus Health Inc. - a GSK company
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

14 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

CoughRespiration DisordersRespiratory Tract DiseasesSigns and SymptomsSigns and Symptoms, RespiratoryPathological Conditions, Signs and Symptoms

Criteria

Inclusion Criteria: * Participants who are healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, clinical laboratory tests, vital sign measurements, and 12-lead ECGs including the following: * Seated blood pressure (after 5 mins), average of 3 readings, is greater than or equal to (\>=) 90/55 millimetre of mercury (mmHg) and less than or equal (\<=)140/90 mmHg at the screening visit. * Seated heart rate, average of 3 readings, is \>= 40 beats per minutes (bpm) and \<= 99 bpm at the screening visit. * Corrected QT interval using the Fridericia formula (QTcF) on ECG, average of 3 readings, is \<= 450 millisecond (msec) and 12-lead ECG findings considered normal or not clinically significant by the investigator or designee at the screening visit. * Aspartate transferase (AST), Alanine transaminase (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 x upper limit of normal may be repeated once * Continuous non-smoker who has never used nicotine- or tobacco-containing products or light smoker for the last 6 months prior to study screening * Body weight ≥ 50.0 kilogram (kg) and Body mass index (BMI) within the range 18.5 to 32.0 kilogram per meter square (kg/m2) (inclusive) at Screening. * Male and female participants must follow protocol-specified contraception guidance. * Female participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies * Is a woman of nonchildbearing potential (WONCBP) * Is a Woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective * A WOCBP must have a negative highly sensitive serum pregnancy test within 24 hours before the first dose of study intervention (i.e., Day -1 of each treatment period) * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. * Must be willing and able to comply with the protocol. Exclusion Criteria: * History or presence of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, biliary (including gallstones or previous cholecystectomy), endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data. * Have a history of malignant neoplasm (excepting definitively treated non melanoma skin cancer or carcinoma in situ of the uterine cervix, which may be enrolled at any time) within the last 5 years. * Past or intended use of over-the-counter or prescription medication including herbal medications within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to dosing. * Participation in the clinical study would result in loss of blood or blood products in excess of 500 milliliter (mL) within 3 months. * Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day. * Current enrolment or past participation in another investigational clinical study in which an investigational intervention (e.g., drug, vaccine, invasive device) was administered within the last 30 days or 5.5 half-lives before signing of consent in any other clinical study involving an investigational study intervention or any other type of medical research. * Current enrolment or past participation in this clinical study. * Positive pre-study drug/alcohol screen, including tetrahydrocannabinol. * Positive Human immunodeficiency virus (HIV) antibody test. * Positive coronavirus (severe acute respiratory syndrome coronavirus 2 \[SARS-CoV-2\]) polymerase chain reaction test at check-in. * 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. * Positive Hepatitis C virus (HCV) antibody test result at screening or within 3 months prior to starting study intervention. * Total bilirubin \>1.5x upper limit of normal (ULN), including participants with Gilbert's syndrome. * Regular alcohol consumption within 6 months prior to the clinical study defined as: For sites in United States of America (USA), an average weekly intake of 3 units for males or 1.5 units for females. * History of known drugs of abuse, including tetrahydrocannabinol, in last 5 years. * Sensitivity to heparin or heparin-induced thrombocytopenia. * Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the clinical study. * Use of any products intended to treat medical conditions that are not approved by the governing health authority in a given country or region (for example, herbal medicine, health supplements, traditional medicine, homeopathic remedies, etc.), within past 30 days prior to signing the consent and during the study. * Any dietary restrictions that would prevent the participant from consuming the site menu/meals.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
In sequence 1, eligible participants will be randomly assigned to 1 of 2 sequences to receive single dose of GSK5464714- Camlipixant on Day 1 under fasting condition (Treatment A), followed by single dose of GSK5464714 in fed condition (Treatment B). There will be a washout period of minimum 7 days between each period.

Group II

Experimental
In sequence 2, eligible participants will be randomly assigned to 1 of 2 sequences to receive single dose of GSK5464714- Camlipixant on Day 1 in fed condition (Treatment B), followed by single dose of GSK5464714 under fasting condition (Treatment A). There will be a washout period of minimum 7 days between each period.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

GSK Investigational Site

Austin, United StatesOpen GSK Investigational Site in Google Maps
CompletedOne Study Center