A Study Investigating the Absolute Oral Bioavailability of Balovaptan After Single and Multiple Daily Oral Doses of Balovaptan in Healthy Volunteers

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-10

Study Completion Date

2019-03-15

Brief Summary

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This study was a non-randomized, open-label, parallel group, two-treatment study in healthy volunteers to investigate the absolute oral bioavailability of balovaptan. The study was conducted at 1 site in the Netherlands.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1

Participants received the study drug at dose level A in 2 periods. There was a minimum of a 14-day wash out period between Day 1 of Period 1 and Day 1 of Period 2.

Group Type EXPERIMENTAL

Oral Balovaptan

Intervention Type DRUG

In Period 1, balovaptan was administered as a single oral dose.

In Period 2, balovaptan was administered as an oral dose once daily on Day 1 to Day 14.

IV Balovaptan

Intervention Type DRUG

In Period 1, IV infusion of balovaptan was administered after the balovaptan oral dose.

In Period 2, IV infusion of balovaptan was administered after the final oral dose of balovaptan.

Cohort 2

Participants received the study drug at dose level B in 2 periods. There was a minimum of a 14-day wash out period between Day 1 of Period 1 and Day 1 of Period 2.

Group Type EXPERIMENTAL

Oral Balovaptan

Intervention Type DRUG

In Period 1, balovaptan was administered as a single oral dose.

In Period 2, balovaptan was administered as an oral dose once daily on Day 1 to Day 14.

IV Balovaptan

Intervention Type DRUG

In Period 1, IV infusion of balovaptan was administered after the balovaptan oral dose.

In Period 2, IV infusion of balovaptan was administered after the final oral dose of balovaptan.

Interventions

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Oral Balovaptan

In Period 1, balovaptan was administered as a single oral dose.

In Period 2, balovaptan was administered as an oral dose once daily on Day 1 to Day 14.

Intervention Type DRUG

IV Balovaptan

In Period 1, IV infusion of balovaptan was administered after the balovaptan oral dose.

In Period 2, IV infusion of balovaptan was administered after the final oral dose of balovaptan.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female subjects. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, urinalysis, and serology.
* Body Mass Index of 18 to 30 kg/m2, inclusive.
* For women of childbearing potential: agreement to use at least 2 acceptable contraceptive methods during the treatment period and for 90 days after the last dose of study drug.
* For men: agreement to use contraceptive measures, and agreement to refrain from donating sperm until 90 days after the last dose of study drug.

Exclusion Criteria

* Female subjects who are pregnant or lactating.
* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes