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Sequence 1 for Cough

Phase 1
Recruiting
Research Sponsored by Bellus Health Inc. - a GSK company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 weeks
Awards & highlights

Summary

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Area Under the Plasma Concentration-Time Curve (AUC) from Time Zero to Infinity Post-Dose [AUC(0-inf)
Maximum Observed Plasma Drug Concentration (Cmax)
Secondary study objectives
AUC from Time Zero to Last Quantifiable Concentration [AUC(0-t)
Absolute Values for 12- Lead Electrocardiogram (ECG) Over Time
Absolute Values for Clinical Laboratory Parameters Over Time
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Sequence 2Experimental Treatment1 Intervention
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.
Group II: Sequence 1Experimental Treatment1 Intervention
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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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Bellus Health Inc. - a GSK companyLead Sponsor
18 Previous Clinical Trials
5,320 Total Patients Enrolled
7 Trials studying Cough
2,164 Patients Enrolled for Cough
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,601 Previous Clinical Trials
6,144,998 Total Patients Enrolled
6 Trials studying Cough
135 Patients Enrolled for Cough
~9 spots leftby Sep 2025
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