Study to Investigate the Effect of Balovaptan on the QTC Interval in Healthy Subjects



Status:Recruiting
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 60
Updated:4/4/2019
Start Date:February 7, 2019
End Date:June 27, 2019
Contact:Reference Study ID Number: WP40734 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. and Canada)

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A Single-Center, Multiple-Dose, Randomized, Double-Blind, Placebo-Controlled, Cross-Over Study to Investigate the Effect of Balovaptan on the QTC Interval in Healthy Subjects

This will be a single-center, multiple-dose, randomized, double-blind, placebo-controlled,
positive-controlled, twelve sequence, 3-period cross-over study to investigate the effect of
balovaptan on the QTc interval in healthy subjects.


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 1 acceptable form of
contraception during the entire study and for 90 days following last dose of study
drug.

- For men: vasectomized, agreement to remain abstinent or use of a condom during
intercourse. Must also agree to refrain from donating sperm.

- Fluent in English.

Exclusion Criteria:

- If female, a positive pregnancy test at screening or prior to Day 1 of any Treatment
Period.

- Lactating women.

- 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 or designee.
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Lenexa, KS
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