A Study in Healthy Male Subjects to Investigate Whether Administration of Rifampicin Can Affect the Fate of Clazosentan in the Body of Clazosentan

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: Clazosentan; Drug: Rifampicin; Other: Saline (0.9% sodium chloride)

• Registration Number: NCT03596294
• Lead Sponsor: Idorsia Pharmaceuticals Ltd.

Brief Summary

A study in healthy male subjects to investigate whether administration of rifampicin can affect the fate in the body (amount and time of presence in the blood) of clazosentan

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-05
• Study Start: 2018-07-19
• Study First Submitted QC: 2018-07-20
• Study First Posted: 2018-07-23
• Primary Completion: 2018-08-03
• Study Completion: 2018-08-03
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-22
• Last Update Posted: 2018-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 14

Inclusion Criteria

• Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
• Healthy male subjects aged between 18 and 65 years (inclusive) at Screening.
• Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) at Screening.
• Systolic blood pressure (SBP) 100-145 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and pulse rate 45-90 bpm (inclusive), measured on the same arm, after 5 min in the supine position at Screening and on Day -1 of the first Period.
• Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests.

Study-specific criteria

• Acceptance for the duration of the study and for 3 months thereafter to use a condom and not to procreate.

Exclusion Criteria

• Previous exposure to clazosentan.
• Previous exposure to rifampicin within 3 months prior to Screening.
• Known hypersensitivity to clazosentan or rifampicin or treatments of the same class, or any of their excipients.
• Known hypersensitivity or allergy to natural rubber latex.
• Participation in a clinical study involving study treatment administration within 3 months prior to Screening or in more than 4 clinical studies within 1 year prior to Screening.
• History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to Screening.
• Positive results for hepatitis B surface antigen or hepatitis C virus antibody at Screening.
• Positive results from the HIV serology at Screening.
• Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment sequence BA	Saline (0.9% sodium chloride)	Period B: Rifampicin + clazosentan Period A: Saline + clazosentan
Treatment sequence AB	Saline (0.9% sodium chloride)	Period A: Saline + clazosentan Period B: Rifampicin + clazosentan
Treatment sequence AB	Clazosentan	Period A: Saline + clazosentan Period B: Rifampicin + clazosentan
Treatment sequence AB	Rifampicin	Period A: Saline + clazosentan Period B: Rifampicin + clazosentan
Treatment sequence BA	Rifampicin	Period B: Rifampicin + clazosentan Period A: Saline + clazosentan
Treatment sequence BA	Clazosentan	Period B: Rifampicin + clazosentan Period A: Saline + clazosentan

Primary Outcome Measures

Name	Time	Method
AUC from zero to time t of the last measured concentration above the limit of quantification	24 hours post treatment infusion initiation	The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles
AUC from zero to infinity (AUC0-inf)	24 hours post treatment infusion initiation	The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles
The maximum plasma concentration (Cmax)	24 hours post treatment infusion initiation	The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles
Volume of distribution at steady state (Vss)	24 hours post treatment infusion initiation	The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles
AUC from zero to 3 h (AUC0-3)	24 hours post treatment infusion initiation	The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles
Terminal half-life (t½)	24 hours post treatment infusion initiation	The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles
Total body clearance (CL)	24 hours post treatment infusion initiation	The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles

Trial Locations

Locations (1)

QPS Netherlands B.V.; 🇳🇱 Groningen, Netherlands