Study to Investigate the Effect of Balovaptan on the QTC Interval in Healthy Subjects
NCT03808298 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 57
Last updated 2020-07-24
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.
Conditions
- Healthy Volunteers
Interventions
- DRUG
-
Balovaptan therapeutic dose Treatment A
Days 1-14: A single once daily dose at dose level A of balovaptan for 14 days
- DRUG
-
Balovaptan supra-therapeutic dose Treatment B
Days 1-14: A single once daily oral dose at dose level B of balovaptan for 14 days.
- DRUG
-
Active control [moxifloxacin] on Day 2 Treatment C
Day 2: A single oral dose of 400 mg moxifloxacin capsule.
- DRUG
-
Active control [Moxifloxacin] on Day 15 Treatment D
Day 15: A single oral dose of 400 mg moxifloxacin capsule.
- DRUG
-
Placebo for Balovaptan Treatment C
Days 1-14: Matching placebo for balovaptan for 14 days.
- DRUG
-
Placebo for Balovaptan Treatment D
Days 1-14: Matching placebo for balovaptan for 14 days.
- DRUG
-
Placebo for Moxifloxacin Treatment A
Day 2 and 15: A single oral dose of a matching placebo capsule for moxifloxacin.
- DRUG
-
Placebo for Moxifloxacin Treatment B
Days 2 and 15: Single oral dose of a matching placebo capsule of moxifloxacin.
- DRUG
-
Moxifloxacin Treatment C
Day 2: A single oral dose of 400 mg moxifloxacin capsule.
- DRUG
-
Placebo for Moxifloxacin Treatment C
Day 15: A single oral dose of a matching placebo capsule for moxifloxacin.
- DRUG
-
Placebo for Moxifloxacin Treatment D
Day 2: A single oral dose of a matching placebo capsule for moxifloxacin.
- DRUG
-
Moxifloxacin Treatment D
Day 15: A single oral dose of 400 mg moxifloxacin capsule.
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-02-07
- Primary Completion
- 2019-06-14
- Completion
- 2019-07-13
- FDA Drug
- Yes
Countries
- United States
Study Locations
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