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

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 - Balovaptan-itraconazole DDI study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46113

Enrollment

Registered

2018-06-05

Start date

2018-06-20

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

autisme spectrum stoornissen (ASS) Autism Spectrum Disorders (ASD)

Interventions

Balovaptan will be given once daily, at a dose of 5 mg, for the initial 4 volunteers (Group A). Based on the results from Group A, the dose of balovaptan may either: - remain at 5 mg once daily in

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
To investigate the effect of itraconazole treatment on the PK of balovaptan and its major metabolites M2 (as applicable) and M3, at steady state.	—

Secondary

Measure	Time frame
To explore the safety and tolerability of balovaptan when given alone and in combination with itraconazole in healthy subjects. Tertiary/Exploratory: Relationship between the CYP3A4 genotype, among others, and steady state balovaptan exposure, and the influence of the CYP3A4 genotype, among others, on the effect of itraconazole on balovaptan PK. The plasma exposure of itraconazole and hydroxy-itraconazole. The relationship between other genotypes and PK of balovaptan may also be explored	—

Measure

Time frame

To explore the safety and tolerability of balovaptan when given alone and in combination with itraconazole in healthy subjects. Tertiary/Exploratory: Relationship between the CYP3A4 genotype, among others*, and steady state balovaptan exposure, and the influence of the CYP3A4 genotype, among others, on the effect of itraconazole on balovaptan PK. The plasma exposure of itraconazole and hydroxy-itraconazole. * The relationship between other genotypes and PK of balovaptan may also be explored

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)