A single-center, non-randomized, open-label, one-sequence, two-period within-subject study to investigate the effect of Rifampicin on the pharmacokinetics of multiple doses of Balovaptan in healthy volunteers
- Conditions
- Autisme spectrum stoornissen (ASS)Autism Spectrum Disorders (ASD)
- Registration Number
- NL-OMON46088
- Lead Sponsor
- PRA Health F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
1. Healthy male and female subjects, aged 18-65, inclusive at screening.
2. BMI of 18-30Kg/m2, inclusive at screening
3. Women of childbearing potential must agree to use one highly effective non-hormonal contraceptive method combined with a barrier method from screening until 90 days after the last drug dose.
4. Men must agree to use contraceptive measures and refrain from donating sperm.
5. Able to participate and willing to give written informed consent and to comply with the study restrictions.
1. Female subjects who are pregnant or lactating.
2. If female of childbearing potential, a positive serum pregnancy test at Screening or at admission (Day 1 of either period).
3. Any condition or disease detected during the medical interview/physical examination that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the Investigator.
4. History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological, lymphatic, musculoskeletal, genitourinary, immunological, dermatological, connective tissue or allergic disease, metabolic disorder, or cancer.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To investigate the effect of multiple doses of rifampicin on the<br /><br>pharmacokinetics of balovaptan and its major metabolites at steady state in<br /><br>healthy subjects</p><br>
- Secondary Outcome Measures
Name Time Method <p>To evaluate the safety and tolerability of balovaptan administered alone and in<br /><br>combination with rifampicin in healthy subjects.<br /><br>To investigate the effect of multiple doses of rifampicin on secondary PK<br /><br>parameters of multiple doses of balovaptan and its major metabolites at steady<br /><br>state in healthy subjects</p><br>