NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

CompletedPhase 1

Sponsor: Hoffmann-La Roche

Conditions: Healthy Volunteers

Interventions: Balovaptan therapeutic dose Treatment A, Balovaptan supra-therapeutic dose Treatment B, Active control [moxifloxacin] on Day 2 Treatment C, Active control [Moxifloxacin] on Day 15 Treatment D, Placebo for Balovaptan Treatment C

Countries: United States

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 QTc interval in healthy subjects.

Eligibility overview

Sex: ALL

Age: 18 Years to 60 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Lenexa, Kansas, United States