Clinical trial NCT06497517: A Study to Investigate the Effect of Food on Camlipixant Concentrations in Healthy Participants
Official title: A Phase 1, Single Center, Single Dose, Open-Label, Randomized, 2-Way Crossover Study to Investigate the Food Effect on the Pharmacokinetics of Camlipixant in Healthy Male and Female Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cough
Keywords: Camlipixant
GSK5464714-camlipixant
Healthy Participants
Pharmacokinetics
Cross-over Study
Lead sponsor: Bellus Health Inc. - a GSK company
Sponsor class: INDUSTRY
First posted: 2024-07-11
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


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 ECGs including the following:

  * Seated blood pressure (after 5 mins), average of 3 readings, is greater than or equal to (\>=) 90/55 millimetre of mercury (mmHg) and less than or equal (\<=)140/90 mmHg at the screening visit.
  * Seated heart rate, average of 3 readings, is \>= 40 beats per minutes (bpm) and \<= 99 bpm at the screening visit.
  * Corrected QT interval using the Fridericia formula (QTcF) on ECG, average of 3 readings, is \<= 450 millisecond (msec) and 12-lead ECG findings considered normal or not clinically significant by the investigator or designee at the screening visit.
* Aspartate transferase (AST), Alanine transaminase (ALT), direct bilirubin, indirect bilirubin, and total bilirubin within normal ranges at the screening visit and check-in. Only abnormal values up to 1.5 x upper limit of normal may be repeated once
* Continuous non-smoker who has never used nicotine- or tobacco-containing products or light smoker for the last 6 months prior to study screening
* Body weight ≥ 50.0 kilogram (kg) and Body mass index (BMI) within the range 18.5 to 32.0 kilogram per meter square (kg/m2) (inclusive) at Screening.
* Male and female participants must follow protocol-specified contraception guidance.
* Female participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies

  * Is a woman of nonchildbearing potential (WONCBP)
  * Is a Woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective
  * A WOCBP must have a negative highly sensitive serum pregnancy test within 24 hours before the first dose of study intervention (i.e., Day -1 of each treatment period)
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the 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, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
* Have a history of malignant neoplasm (excepting definitively treated non melanoma skin cancer or carcinoma in situ of the uterine cervix, which may be enrolled at any time) within the last 5 years.
* Past or intended use of over-the-counter or prescription medication including herbal medications within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to dosing.
* Participation in the clinical study would result in loss of blood or blood products in excess of 500 milliliter (mL) within 3 months.
* Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.
* Current enrolment or past participation in another investigational clinical study in which an investigational intervention (e.g., drug, vaccine, invasive device) was administered within the last 30 days or 5.5 half-lives before signing of consent in any other clinical study involving an investigational study intervention or any other type of medical research.
* Current enrolment or past participation in this clinical study.
* Positive pre-study drug/alcohol screen, including tetrahydrocannabinol.
* Positive Human immunodeficiency virus (HIV) antibody test.
* Positive coronavirus (severe acute respiratory syndrome coronavirus 2 \[SARS-CoV-2\]) polymerase chain reaction test at check-in.
* Presence of Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) at screening or within 3 months prior to first dose of study intervention.
* Positive Hepatitis C virus (HCV) antibody test result at screening or within 3 months prior to starting study intervention.
* Total bilirubin \>1.5x upper limit of normal (ULN), including participants with Gilbert's syndrome.
* Regular alcohol consumption within 6 months prior to the clinical study defined as: For sites in United States of America (USA), an average weekly intake of 3 units for males or 1.5 units for females.
* History of known drugs of abuse, including tetrahydrocannabinol, in last 5 years.
* Sensitivity to heparin or heparin-induced thrombocytopenia.
* Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the clinical study.
* Use of any products intended to treat medical conditions that are not approved by the governing health authority in a given country or region (for example, herbal medicine, health supplements, traditional medicine, homeopathic remedies, etc.), within past 30 days prior to signing the consent and during the study.
* Any dietary restrictions that would prevent the participant from consuming the site menu/meals.

Primary outcomes:
measure: Area Under the Plasma Concentration-Time Curve (AUC) from Time Zero to Infinity Post-Dose [AUC(0-inf)
timeFrame: Up to Day 3 for each period
measure: Maximum Observed Plasma Drug Concentration (Cmax)
timeFrame: Up to Day 3 for each period
Secondary outcomes:
measure: Time to Maximum Observed Plasma Drug Concentration (Tmax)
timeFrame: Up to Day 3 for each period
measure: Apparent Terminal Phase Half-Life (t½)
timeFrame: Up to Day 3 for each period
measure: Apparent Oral Clearance (CL/F)
timeFrame: Up to Day 3 for each period
measure: AUC from Time Zero to Last Quantifiable Concentration [AUC(0-t)
timeFrame: Up to Day 3 for each period
measure: Apparent Volume of Distribution (Vz/F)
timeFrame: Up to Day 3 for each period
measure: Number of Participants Reported for Adverse events, Serious Adverse Events and Adverse Events of Special Interest
timeFrame: Up to 3 weeks
measure: Absolute Values for Clinical Laboratory Parameters Over Time
timeFrame: Up to 3 weeks
measure: Absolute Values for 12- Lead Electrocardiogram (ECG) Over Time
timeFrame: Up to 3 weeks
measure: Absolute Values for Vital Sign Measurements Over Time
timeFrame: Up to 3 weeks
measure: Changes from Baseline for Clinical Laboratory Parameters Over Time
timeFrame: Up to 3 weeks
measure: Changes from Baseline for 12- Lead ECG Over Time
timeFrame: Up to 3 weeks
measure: Changes from Baseline for Vital Sign Measurements Over Time
timeFrame: Up to 3 weeks
Other outcomes:
Locations:
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: