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

Healthy Subjects Clinical Trial

Official title:

A Single-center, Randomized, Double-blind, Two-period Cross-over Study to Investigate the Effect of Rifampicin on the Pharmacokinetics of Clazosentan in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03596294
• Other study ID #: ID-054-106
• Secondary ID: 2018-001607-36
• Status: Completed
• Phase: Phase 1
• Start date: July 19, 2018
• Est. completion date: August 3, 2018

Study information

• Verified date: October 2018
• Source: Idorsia Pharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 3, 2018
• Est. primary completion date: August 3, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• Clazosentan
Continuous i.v. infusion of 15 mg/h of clazosentan for 3 h
• Rifampicin
Single i.v. dose of 600 mg rifampicin for 30 min

Other:
• Saline (0.9% sodium chloride)
Single i.v infusion of 500 mL saline for 30 min

Locations

Country	Name	City	State
Netherlands	QPS Netherlands B.V.	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Idorsia Pharmaceuticals Ltd.

Country where clinical trial is conducted

Netherlands, 

Outcome

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