Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT03596294
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.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03596294
Study Brief:
Protocol Section:
NCT03596294