Cough
Conditions
Keywords
Camlipixant, GSK5464714, Cough, Refractory Chronic Cough, Unexplained Chronic Cough, Pharmacokinetics, Safety, Tolerability, Prototypes, Healthy
Brief 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.
Interventions
DRUGCamlipixant
Camlipixant will be administered.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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 * Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. * Must be willing and able to comply with the protocol.
Exclusion criteria
* History or presence of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, biliary (including gallstones or previous cholecystectomy), endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, distribution, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data. * Evidence of current SARS-CoV-2, confirmed by antigen testing, prior to admission in each period. * Alanine transaminase (ALT) \>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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Observed Concentration of Camlipixant at 24 hours (C24) | 24 hours post dose |
| 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 |
Secondary
| Measure | 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) | Up to 26 Weeks |
Countries
United Kingdom
Contacts
STUDY_DIRECTORGSK Clinical Trials
GlaxoSmithKline
Outcome results
None listed