Clinical trial NCT05899829: Evaluation of the Effect of Rifampin and Rabeprazole on the Pharmacokinetics of Camlipixant
Official title: A Phase 1, 2-part, Open-label, Fixed-sequence Study Evaluating the Effect of Rifampin (Part 1) and Rabeprazole (Part 2) on the Pharmacokinetics of a Single Dose of Camlipixant (BLU-5937) 50 mg Tablet in Healthy Participants Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cough
Healthy
Lead sponsor: Bellus Health Inc. - a GSK company
Sponsor class: INDUSTRY
First posted: 2023-06-12
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase 1, 2-part, open-label, fixed-sequence study evaluating the effect of rifampin (part 1) and rabeprazole (part 2) on the pharmacokinetics of a single dose of camlipixant (BLU-5937) 50 mg tablet in healthy participants under fasting conditions.


Eligibility criteria: Inclusion Criteria:

* Healthy males or non-pregnant, non-lactating healthy females

Exclusion Criteria:

* History of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disorder, as judged by the investigator.

Primary outcomes:
measure: Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-Infinity]) of Camlipixant
timeFrame: Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11
measure: Part 2: AUC(0-Infinity) of Camlipixant
timeFrame: Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10
measure: Part 1: Area Under the Plasma Concentration-time Curve From Time Zero Until the Last Observed Concentration (AUC[0-t]) of Camlipixant
timeFrame: Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11
measure: Part 2: AUC(0-t) of Camlipixant
timeFrame: Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10
measure: Part 1: Maximum Observed Concentration (Cmax) of Camlipixant
timeFrame: Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11
measure: Part 2: Cmax of Camlipixant
timeFrame: Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10
Secondary outcomes:
measure: Part 1: Time to Reach Maximum Observed Concentration (Tmax) of Camlipixant
timeFrame: Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11
measure: Part 2: Tmax of Camlipixant
timeFrame: Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10
measure: Part 1: Terminal Elimination Half-Life (T1/2) Following Administration of Camlipixant
timeFrame: Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11
measure: Part 2: T1/2 Following Administration of Camlipixant
timeFrame: Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10
measure: Part 1: Percentage of AUC0-Infinity Due to Extrapolation From the Time of the Last Observed Concentration to Infinity (% AUC Extrapolation) of Camlipixant
timeFrame: Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11
measure: Part 2: % AUC Extrapolation of Camlipixant
timeFrame: Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10
measure: Part 1: Terminal Elimination Rate Constant of Camlipixant
timeFrame: Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11
measure: Part 2: Terminal Elimination Rate Constant of Camlipixant
timeFrame: Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10
measure: Part 1: Apparent Clearance (CL/F) of Camlipixant
timeFrame: Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11
measure: Part 2: CL/F of Camlipixant
timeFrame: Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10
measure: Part 1: Apparent Oral Volume of Distribution (Vz/F) of Camlipixant
timeFrame: Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11
measure: Part 2: Vz/F of Camlipixant
timeFrame: Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10
measure: Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs) and Treatment-emergent Adverse Events of Medical Interest (TEAEMIs)
timeFrame: Up to Day 22 for Part1 (Day1 post-dose until Day4 pre-dose of rifampin [Camlipixant 50mg];From Day4 dosing until Day11 pre-dose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study [Day 22] [Camlipixant 50mg+Rifampin 600mg]
measure: Part 2: Number of Participants With TEAEs, TESAEs and TEAEMIs
timeFrame: Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg]
measure: Part 1: Number of Participants With Abnormal Clinically Significant Changes in 12-Lead Electrocardiogram (ECG) Findings
timeFrame: Day 4, Day 11, and Day 13
measure: Part 2: Number of Participants With Abnormal Clinically Significant Changes in 12-Lead ECG Findings
timeFrame: Day 4, Day 10, and Day 12
measure: Part 1: Number of Participants With Abnormal Clinically Significant Changes in Vital Signs: Diastolic Blood Pressure (DBP), Systolic Blood Pressure (SBP), and Heart Rate
timeFrame: Day 11 and Day 13
measure: Part 2: Number of Participants With Abnormal Clinically Significant Changes in Vital Signs: DBP, SBP, and Heart Rate
timeFrame: Day 10 and Day 12
measure: Part 1: Number of Participants With Abnormal Clinically Significant Changes in Vital Signs: Respiratory Rate and Oral Temperature
timeFrame: Day 13
measure: Part 2: Number of Participants With Abnormal Clinically Significant Changes in Vital Signs: Respiratory Rate and Oral Temperature
timeFrame: Day 12
measure: Part 1: Number of Participants With Abnormal Clinically Significant Changes in Physical Examination
timeFrame: Up to Day 13
measure: Part 2: Number of Participants With Abnormal Clinically Significant Changes in Physical Examination
timeFrame: Up to Day 12
measure: Part 1: Number of Participants With Abnormal Clinically Significant Changes in Hematology Parameters
timeFrame: Up to Day 13
measure: Part 2: Number of Participants With Abnormal Clinically Significant Changes in Hematology Parameters
timeFrame: Up to Day 12
measure: Part 1: Number of Participants With Abnormal Clinically Significant Changes in Clinical Chemistry Parameters
timeFrame: Up to Day 13
measure: Part 2: Number of Participants With Abnormal Clinically Significant Changes in Clinical Chemistry Parameters
timeFrame: Up to Day 12
measure: Part 1: Number of Participants With Abnormal Clinically Significant Changes in Coagulation Parameters
timeFrame: Up to Day 13
measure: Part 2: Number of Participants With Abnormal Clinically Significant Changes in Coagulation Parameters
timeFrame: Up to Day 12
measure: Part 1: Number of Participants With Abnormal Clinically Significant Changes in Urinalysis
timeFrame: Up to Day 13
measure: Part 2: Number of Participants With Abnormal Clinically Significant Changes in Urinalysis
timeFrame: Up to Day 12
Other outcomes:
Locations:
city: Quebec City
country: Canada
facility: GSK Investigational Site
state: Quebec
Study officials:
References: