Clinical trial NCT03596294: A Study in Healthy Male Subjects to Investigate Whether Administration of Rifampicin Can Affect the Fate of Clazosentan in the Body of Clazosentan
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Idorsia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2018-07-23
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, double-blind, two-period, cross-over Phase 1 study
Primary purpose: OTHER

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


Eligibility criteria: 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.

Primary outcomes:
measure: AUC from zero to time t of the last measured concentration above the limit of quantification
timeFrame: 24 hours post treatment infusion initiation
measure: AUC from zero to infinity (AUC0-inf)
timeFrame: 24 hours post treatment infusion initiation
measure: AUC from zero to 3 h (AUC0-3)
timeFrame: 24 hours post treatment infusion initiation
measure: The maximum plasma concentration (Cmax)
timeFrame: 24 hours post treatment infusion initiation
measure: Terminal half-life (t½)
timeFrame: 24 hours post treatment infusion initiation
measure: Total body clearance (CL)
timeFrame: 24 hours post treatment infusion initiation
measure: Volume of distribution at steady state (Vss)
timeFrame: 24 hours post treatment infusion initiation
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: QPS Netherlands B.V.
Study officials:
affiliation: Idorsia Pharmaceuticals Ltd.
name: Clinical Trials
role: STUDY_DIRECTOR
References: