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Suspended NCT07684586

A Study to Investigate the Difference In Blood Levels of Camlipixant Between Different Camlipixant Formulation Prototypes

Conditions: Cough

Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 28
Sponsor: GlaxoSmithKline

Location: GSK Investigational Site Nottingham Nottinghamshire

Summary

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.

Eligibility 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 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 \[\1.0x Upper limit of normal (ULN) * Total bilirubin \>1.0 x ULN. Participants with Gilbert's syndrome are excluded. * QT interval corrected for heart rate according to Fridericia's formula (QTcF) \>450 millisecond (msec) * Participants with abnormal 12-lead ECG findings considered clinically significant by the investigator or designee at the screening visit.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07684586). StuddyBuddy aggregates publicly available trial information.