57
Participants
Start Date
February 7, 2019
Primary Completion Date
June 14, 2019
Study Completion Date
July 13, 2019
Balovaptan therapeutic dose Treatment A
Days 1-14: A single once daily dose at dose level A of balovaptan for 14 days
Balovaptan supra-therapeutic dose Treatment B
Days 1-14: A single once daily oral dose at dose level B of balovaptan for 14 days.
Active control [moxifloxacin] on Day 2 Treatment C
Day 2: A single oral dose of 400 mg moxifloxacin capsule.
Active control [Moxifloxacin] on Day 15 Treatment D
Day 15: A single oral dose of 400 mg moxifloxacin capsule.
Placebo for Balovaptan Treatment C
Days 1-14: Matching placebo for balovaptan for 14 days.
Placebo for Balovaptan Treatment D
Days 1-14: Matching placebo for balovaptan for 14 days.
Placebo for Moxifloxacin Treatment A
Day 2 and 15: A single oral dose of a matching placebo capsule for moxifloxacin.
Placebo for Moxifloxacin Treatment B
Days 2 and 15: Single oral dose of a matching placebo capsule of moxifloxacin.
Moxifloxacin Treatment C
Day 2: A single oral dose of 400 mg moxifloxacin capsule.
Placebo for Moxifloxacin Treatment C
Day 15: A single oral dose of a matching placebo capsule for moxifloxacin.
Placebo for Moxifloxacin Treatment D
Day 2: A single oral dose of a matching placebo capsule for moxifloxacin.
Moxifloxacin Treatment D
Day 15: A single oral dose of 400 mg moxifloxacin capsule.
PRA International Clinical Pharmacology Center (EDS US Clinic), Lenexa
Hoffmann-La Roche
INDUSTRY