Study to Investigate the Effect of Balovaptan on the QTC Interval in Healthy Subjects
Condition: Healthy Volunteers
Intervention: 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; Placebo for Balovaptan Treatment D; Placebo for Moxifloxacin Treatment A; Placebo for Moxifloxacin Treatment B; Moxifloxacin Treatment C; Placebo for Moxifloxacin Treatment C; Placebo for Moxifloxacin Treatment D; Moxifloxacin Treatment D
Intervention description: Days 1-14: A single once daily dose at dose level A of balovaptan for 14 days; Days 1-14: A single once daily oral dose at dose level B of balovaptan for 14 days.; Day 2: A single oral dose of 400 mg moxifloxacin capsule.; Day 15: A single oral dose of 400 mg moxifloxacin capsule.; Days 1-14: Matching placebo for balovaptan for 14 days.; Days 1-14: Matching placebo for balovaptan for 14 days.; Day 2 and 15: A single oral dose of a matching placebo capsule for moxifloxacin.; Days 2 and 15: Single oral dose of a matching placebo capsule of moxifloxacin.; Day 2: A single oral dose of 400 mg moxifloxacin capsule.; Day 15: A single oral dose of a matching placebo capsule for moxifloxacin.; Day 2: A single oral dose of a matching placebo capsule for moxifloxacin.; Day 15: A single oral dose of 400 mg moxifloxacin capsule.
Intervention MeSH terms: Moxifloxacin; Balovaptan; Norgestimate, ethinyl estradiol drug combination
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

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 QTc interval in healthy subjects.
    

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.