Phase 1 Completed N=25 Treatment

Evaluation of the Potential Drug-drug Interactions Between Gemfibrozil or Dabigatran Etexilate and Camlipixant

Cough · Healthy

Source: ClinicalTrials.gov NCT05959447 ↗

Enrolled (actual)

Serious AEs

1.1%

Results posted

Mar 2025

Primary outcomePrimary: Part 1: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC-inf) of Camlipixant — 4886.66; 10642.07 Hours*nanograms per milliliter

Summary

This is a phase 1, 2-part, open-label, fixed-sequence study evaluating potential drug-drug interactions between gemfibrozil (part 1) or dabigatran etexilate (part 2) and camlipixant (BLU-5937) 50 mg tablet in healthy participants under fasting conditions.

Outcome Measures

Outcome	Result	p-value
PRIMARY Part 1: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC-inf) of Camlipixant	4886.66; 10642.07	—
PRIMARY Part 1: Area Under the Concentration-time Curve From Time Zero Until the Last Observed Concentration (AUC[0-t]) of Camlipixant	4846.83; 10541.57	—
PRIMARY Part 1: Maximal Observed Concentration (Cmax) of Camlipixant	1078; 1303	—
PRIMARY Part 2: AUC(0-Infinity) of Free Dabigatran	943.49; 1055.20	—
PRIMARY Part 2: AUC(0-t) of Free Dabigatran	920.18; 1031.89	—
PRIMARY Part 2: Cmax of Free Dabigatran	110; 125	—
PRIMARY Part 2: AUC(0-Infinity) of Total Dabigatran	1165.82; 1339.35	—
PRIMARY Part 2: AUC(0-t) of Total Dabigatran	1139.80; 1316.80	—
PRIMARY Part 2: Cmax of Total Dabigatran	135; 160	—
SECONDARY Part 1: Time to Reach Maximum Observed Concentration (Tmax) of Camlipixant	0.750; 0.750	—
SECONDARY Part 1: Terminal Elimination Half-Life (T1/2) Following Administration of Camlipixant	5.56; 9.56	—
SECONDARY Part 1: Percentage of AUC0-Infinity Due to Extrapolation From the Time of the Last Observed Concentration to Infinity (%AUC Extrapolation) of Camlipixant	0.58; 0.59	—
SECONDARY Part 1: Terminal Elimination Rate Constant of Camlipixant (Kel)	0.1247; 0.0725	—
SECONDARY Part 1: Apparent Clearance (CL/F) of Camlipixant	10.23; 4.70	—
SECONDARY Part 1: Apparent Volume of Distribution (Vz/F) of Camlipixant	82.06; 64.80	—
SECONDARY Part 2: Tmax of Free Dabigatran	2.000; 2.000	—
SECONDARY Part 2: T1/2 Following Administration Free Dabigatran	10.49; 9.18	—
SECONDARY Part 2: Percentage of AUC0-Infinity Due to Extrapolation From the Time of the Last Observed Concentration to Infinity (%AUC Extrapolation) of Free Dabigatran	2.22; 1.95	—
SECONDARY Part 2: Kel Free Dabigatran	0.0660; 0.0755	—
SECONDARY Part 2: CL/F Free Dabigatran	158.98; 142.15	—
SECONDARY Part 2: Vz/F Free Dabigatran	2407.03; 1883.56	—
SECONDARY Part 2: Tmax of Total Dabigatran	2.000; 2.000	—
SECONDARY Part 2: T1/2 Following Administration of Total Dabigatran	11.04; 10.21	—
SECONDARY Part 2: Percentage of AUC0-Infinity Due to Extrapolation From the Time of the Last Observed Concentration to Infinity (%AUC Extrapolation) of Total Dabigatran	1.93; 1.58	—
SECONDARY Part 2: Kel of Total Dabigatran	0.0628; 0.0679	—
SECONDARY Part 2: CL/F of Total Dabigatran	128.66; 111.99	—
SECONDARY Part 2: Vz/F of Total Dabigatran	2048.49; 1649.21	—
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)	1; 6; 5; 0; 0; 1	—
SECONDARY Part 2: Number of Participants With TEAEs, TESAEs and TEAEMIs	4; 6; 0; 0; 0; 0	—
SECONDARY Part 1: Number of Participants With Abnormal Clinically Significant Changes in 12-Lead Electrocardiogram (ECG) Findings	0; 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 During Physical Examination	1	—
SECONDARY Part 2: Number of Participants With Abnormal Clinically Significant Changes During 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	3	—
SECONDARY Part 2: Number of Participants With Abnormal Clinically Significant Changes in Clinical Chemistry Parameters	1	—
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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05959447). 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.