Last updated: 06/29/2026 13:50:15
A Study to Investigate the Difference In Blood Levels of Camlipixant Between Different Camlipixant Formulation Prototypes
GSK study ID
223643
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Not yet recruiting
Not yet recruiting
Trial overview
Official title: A Phase 1 Study to Evaluate the PK and Relative Bioavailability of Different Formulation Prototypes of Camlipixant
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Sequential Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Maximum Observed Concentration (Cmax) of Camlipixant
Timeframe: Pre-dose and up to 48 hours post dose
Area Under the Curve from Zero up to 24 hours [AUC (0-24)] of Camlipixant
Timeframe: Pre-dose and up to 24 hours post dose
Observed Concentration of Camlipixant at 24 hours (C24)
Timeframe: 24 hours post dose
Secondary outcomes:
Number of Participants Experiencing Adverse Events (AEs)
Timeframe: Up to 26 Weeks
Number of Participants Experiencing Serious Adverse Events (SAEs)
Timeframe: Up to 26 Weeks
Number of Participants Experiencing Adverse Event of Special Interest (AESI)
Timeframe: Up to 26 Weeks
Interventions:
Drug: Camlipixant
Enrollment:
28
Observational study model:
Not applicable
Primary completion date:
2027-26-08
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Cough
Product
Not applicable
Collaborators
Not applicable
Study date(s)
July 2026 to August 2027
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 55 Years
Accepts healthy volunteers
Yes
- 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).
- 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.
Inclusion and exclusion 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 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.
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Not yet recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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