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This study is a single center, single dose, open-label, randomly assigned 2-way crossover study. The study will investigate the food effect on the pharmacokinetics of Camlipixant (GSK5464714) in healthy male and female participants. Eligible participants will be randomized to pre-defined sequences. There will be a washout of minimum 7 days between each dose of treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | 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. |
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| Sequence 2 | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK5464714- Camlipixant | Drug | GSK5464714- Camlipixant will be administered |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve (AUC) from Time Zero to Infinity Post-Dose [AUC(0-inf) | Up to Day 3 for each period | |
| Maximum Observed Plasma Drug Concentration (Cmax) | Up to Day 3 for each period |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Maximum Observed Plasma Drug Concentration (Tmax) | Up to Day 3 for each period | |
| Apparent Terminal Phase Half-Life (t½) | Up to Day 3 for each period | |
| Apparent Oral Clearance (CL/F) |
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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 ECGs including the following:
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
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:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Austin | Texas | 78744 | United States |
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/
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.
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 |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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This is an open-label study.
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| Up to Day 3 for each period |
| AUC from Time Zero to Last Quantifiable Concentration [AUC(0-t) | Up to Day 3 for each period |
| Apparent Volume of Distribution (Vz/F) | Up to Day 3 for each period |
| Number of Participants Reported for Adverse events, Serious Adverse Events and Adverse Events of Special Interest | Up to 3 weeks |
| Absolute Values for Clinical Laboratory Parameters Over Time | Up to 3 weeks |
| Absolute Values for 12- Lead Electrocardiogram (ECG) Over Time | Up to 3 weeks |
| Absolute Values for Vital Sign Measurements Over Time | Up to 3 weeks |
| Changes from Baseline for Clinical Laboratory Parameters Over Time | Up to 3 weeks |
| Changes from Baseline for 12- Lead ECG Over Time | Up to 3 weeks |
| Changes from Baseline for Vital Sign Measurements Over Time | Up to 3 weeks |
| D013568 | Pathological Conditions, Signs and Symptoms |