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This is an open-label study being conducted in healthy adults, to learn what happens to the study medicine (camlipixant) they are receiving in a person's body over time (a pharmacokinetic [PK] study). The goal of the study is to understand how the body processes camlipixant, to check its safety and how well it is tolerated. Participants will receive camlipixant at different dose levels with different formulation types either on an empty stomach or after a meal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence 1 | Experimental | Participants will receive camlipixant according to the following sequence: formulation A at dose level 1 (fasted) formulation B at dose level 1 (fasted); formulation C at dose level 2 (fasted); formulation A at dose level 4 (fasted); and formulation A at dose level 1 (fed). |
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| Treatment Sequence 2 | Experimental | Participants will receive camlipixant according to the following sequence: formulation A at dose level 1 (fasted) formulation B at dose level 1 (fasted); formulation C at dose level 3 (fasted); formulation A at dose level 4 (fasted); and formulation A at dose level 4 (fed). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camlipixant | Drug | Camlipixant will be administered. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) of Camlipixant | Pre-dose and up to 48 hours post dose | |
| Area Under the Curve from Zero up to 24 hours [AUC (0-24)] of Camlipixant | Pre-dose and up to 24 hours post dose | |
| Observed Concentration of Camlipixant at 24 hours (C24) | 24 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Adverse Events (AEs) | Up to 26 Weeks | |
| Number of Participants Experiencing Serious Adverse Events (SAEs) | Up to 26 Weeks | |
| Number of Participants Experiencing Adverse Event of Special Interest (AESI) |
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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 Electrocardiogram (ECG).
Body weight greater than or equal (>=) 50 kilogram (kg) and body mass index (BMI) within the range 18.5 to 32.0 kilogram per meter square (kg/m^2) (inclusive).
A female participant is eligible to participate if they are not pregnant or breastfeeding, and one of the following conditions applies:
i. Is a participant of non-childbearing potential (PONCBP) as defined in the full protocol.
OR ii. Is a participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective (with a failure rate of less than [<] 1 percent [%], per year
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| US GSK Clinical Trials Call Center | Contact | 877-379-3718 | GSKClinicalSupportHD@gsk.com | |
| EU GSK Clinical Trials Call Center | Contact | +44 (0) 20 89904466 | GSKClinicalSupportHD@gsk.com |
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
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 asset(s) with development terminated across all indications.
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.
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| ID | Term |
|---|---|
| D003371 | Cough |
| D000096822 | Chronic Cough |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| Up to 26 Weeks |
| D013568 | Pathological Conditions, Signs and Symptoms |