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