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

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 - Balovaptan - Rifampicin DDI study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46088

Enrollment

Registered

2018-06-21

Start date

2018-07-03

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

In Period 1, balovaptan will be given once daily for 10 consecutive days, at a dose of 10 mg. Balovaptan will be given as an oral tablet with 240 milliliters (mL) of water after consumption of a sta

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
To investigate the effect of multiple doses of rifampicin on the pharmacokinetics of balovaptan and its major metabolites at steady state in healthy subjects	—

Secondary

Measure	Time frame
To evaluate the safety and tolerability of balovaptan administered alone and in combination with rifampicin in healthy subjects. To investigate the effect of multiple doses of rifampicin on secondary PK parameters of multiple doses of balovaptan and its major metabolites at steady state in healthy subjects	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)