Phase 1
Completed N=20
Evaluation of the Effect of Rifampin and Rabeprazole on the Pharmacokinetics of Camlipixant
Cough · Healthy
Source: ClinicalTrials.gov NCT05899829 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcomePrimary: Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-Infinity]) of Camlipixant — 3851.24; 1423.84 Hours*nanograms per milliliter
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-Infinity]) of Camlipixant |
3851.24; 1423.84 | — |
| PRIMARY Part 2: AUC(0-Infinity) of Camlipixant |
5425.54; 5514.74 | — |
| PRIMARY Part 1: Area Under the Plasma Concentration-time Curve From Time Zero Until the Last Observed Concentration (AUC[0-t]) of Camlipixant |
3834.41; 1419.39 | — |
| PRIMARY Part 2: AUC(0-t) of Camlipixant |
5403.91; 5474.24 | — |
| PRIMARY Part 1: Maximum Observed Concentration (Cmax) of Camlipixant |
819; 519 | — |
| PRIMARY Part 2: Cmax of Camlipixant |
1080; 912 | — |
| SECONDARY Part 1: Time to Reach Maximum Observed Concentration (Tmax) of Camlipixant |
1.000; 0.750 | — |
| SECONDARY Part 2: Tmax of Camlipixant |
0.750; 1.750 | — |
| SECONDARY Part 1: Terminal Elimination Half-Life (T1/2) Following Administration of Camlipixant |
5.05; 1.94 | — |
| SECONDARY Part 2: T1/2 Following Administration of Camlipixant |
6.01; 6.78 | — |
| SECONDARY Part 1: Percentage of AUC0-Infinity Due to Extrapolation From the Time of the Last Observed Concentration to Infinity (% AUC Extrapolation) of Camlipixant |
0.40; 0.30 | — |
| SECONDARY Part 2: % AUC Extrapolation of Camlipixant |
0.34; 0.57 | — |
| SECONDARY Part 1: Terminal Elimination Rate Constant of Camlipixant |
0.1372; 0.3579 | — |
| SECONDARY Part 2: Terminal Elimination Rate Constant of Camlipixant |
0.1153; 0.1022 | — |
| SECONDARY Part 1: Apparent Clearance (CL/F) of Camlipixant |
12.98; 35.12 | — |
| SECONDARY Part 2: CL/F of Camlipixant |
9.22; 9.07 | — |
| SECONDARY Part 1: Apparent Oral Volume of Distribution (Vz/F) of Camlipixant |
94.66; 98.11 | — |
| SECONDARY Part 2: Vz/F of Camlipixant |
79.96; 88.74 | — |
| SECONDARY 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) |
3; 14; 2; 0; 0; 0 | — |
| SECONDARY Part 2: Number of Participants With TEAEs, TESAEs and TEAEMIs |
4; 3; 0; 0; 0; 0 | — |
| SECONDARY Part 1: Number of Participants With Abnormal Clinically Significant Changes in 12-Lead Electrocardiogram (ECG) Findings |
0; 0; 0 | — |
| SECONDARY Part 2: Number of Participants With Abnormal Clinically Significant Changes in 12-Lead ECG Findings |
0; 0; 0 | — |
| SECONDARY Part 1: Number of Participants With Abnormal Clinically Significant Changes in Vital Signs: Diastolic Blood Pressure (DBP), Systolic Blood Pressure (SBP), and Heart Rate |
0; 0 | — |
| SECONDARY Part 2: Number of Participants With Abnormal Clinically Significant Changes in Vital Signs: DBP, SBP, and Heart Rate |
0; 0 | — |
| SECONDARY Part 1: Number of Participants With Abnormal Clinically Significant Changes in Vital Signs: Respiratory Rate and Oral Temperature |
— | — |
| SECONDARY Part 2: Number of Participants With Abnormal Clinically Significant Changes in Vital Signs: Respiratory Rate and Oral Temperature |
— | — |
| SECONDARY Part 1: Number of Participants With Abnormal Clinically Significant Changes in Physical Examination |
— | — |
| SECONDARY Part 2: Number of Participants With Abnormal Clinically Significant Changes in Physical Examination |
— | — |
| SECONDARY Part 1: Number of Participants With Abnormal Clinically Significant Changes in Hematology Parameters |
— | — |
| SECONDARY Part 2: Number of Participants With Abnormal Clinically Significant Changes in Hematology Parameters |
— | — |
| SECONDARY Part 1: Number of Participants With Abnormal Clinically Significant Changes in Clinical Chemistry Parameters |
2 | — |
| SECONDARY Part 2: Number of Participants With Abnormal Clinically Significant Changes in Clinical Chemistry Parameters |
— | — |
| SECONDARY Part 1: Number of Participants With Abnormal Clinically Significant Changes in Coagulation Parameters |
— | — |
| SECONDARY Part 2: Number of Participants With Abnormal Clinically Significant Changes in Coagulation Parameters |
— | — |
| SECONDARY Part 1: Number of Participants With Abnormal Clinically Significant Changes in Urinalysis |
— | — |
| SECONDARY Part 2: Number of Participants With Abnormal Clinically Significant Changes in Urinalysis |
— | — |
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.
Data sourced from ClinicalTrials.gov (NCT05899829). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.