A Single Center, Non-Randomized, Open-Label, One-Sequence, Two-Period Within-Subject Study to Investigate the Effect of Itraconazole on the Pharmacokinetics of Multiple Doses of Balovaptan in Healthy Volunteers
Completed
- Conditions
- autisme spectrum stoornissen (ASS)Autism Spectrum Disorders (ASD)
- Registration Number
- NL-OMON46113
- Lead Sponsor
- F. Hoffmann-La Roche Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
Inclusion Criteria
-Healthy male and female subjects
-18 to 65 years, inclusive, at screening
-BMI: 18 to 30 kg/m2, inclusive, at screening
-Non-smoking
-Women of childbearing potential and men must use contraceptive methods
Exclusion Criteria
Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To investigate the effect of itraconazole treatment on the PK of balovaptan and<br /><br>its major metabolites M2 (as applicable) and M3, at steady state.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To explore the safety and tolerability of balovaptan when given alone and in<br /><br>combination with itraconazole in healthy subjects.<br /><br><br /><br><br /><br>Tertiary/Exploratory:<br /><br>Relationship between the CYP3A4 genotype, among others*, and steady state<br /><br>balovaptan exposure, and the influence of the CYP3A4 genotype, among others, on<br /><br>the effect of itraconazole on balovaptan PK.<br /><br><br /><br>The plasma exposure of itraconazole and hydroxy-itraconazole.<br /><br><br /><br>* The relationship between other genotypes and PK of balovaptan may also be<br /><br>explored</p><br>