Status:
COMPLETED
Study to Investigate the Effect of Balovaptan on the QTC Interval in Healthy Subjects
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
This was 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 QT...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 13 2019
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT03808298
Start Date
February 7 2019
End Date
July 13 2019
Last Update
July 24 2020
Active Locations (1)
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1
PRA International Clinical Pharmacology Center (EDS US Clinic)
Lenexa, Kansas, United States, 66219