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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
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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