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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-07

Study Completion Date

2019-07-13

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Treatment Sequence 1: A, B, C

Group Type EXPERIMENTAL

Balovaptan therapeutic dose Treatment A

Intervention Type DRUG

Days 1-14: A single once daily dose at dose level A of balovaptan for 14 days

Balovaptan supra-therapeutic dose Treatment B

Intervention Type DRUG

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

Intervention Type DRUG

Day 2: A single oral dose of 400 mg moxifloxacin capsule.

Placebo for Balovaptan Treatment C

Intervention Type DRUG

Days 1-14: Matching placebo for balovaptan for 14 days.

Placebo for Moxifloxacin Treatment A

Intervention Type DRUG

Day 2 and 15: A single oral dose of a matching placebo capsule for moxifloxacin.

Placebo for Moxifloxacin Treatment B

Intervention Type DRUG

Days 2 and 15: Single oral dose of a matching placebo capsule of moxifloxacin.

Moxifloxacin Treatment C

Intervention Type DRUG

Day 2: A single oral dose of 400 mg moxifloxacin capsule.

Placebo for Moxifloxacin Treatment C

Intervention Type DRUG

Day 15: A single oral dose of a matching placebo capsule for moxifloxacin.

Treatment Sequence 2: A, C, B

Group Type EXPERIMENTAL

Balovaptan therapeutic dose Treatment A

Intervention Type DRUG

Days 1-14: A single once daily dose at dose level A of balovaptan for 14 days

Balovaptan supra-therapeutic dose Treatment B

Intervention Type DRUG

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

Intervention Type DRUG

Day 2: A single oral dose of 400 mg moxifloxacin capsule.

Placebo for Balovaptan Treatment C

Intervention Type DRUG

Days 1-14: Matching placebo for balovaptan for 14 days.

Placebo for Moxifloxacin Treatment A

Intervention Type DRUG

Day 2 and 15: A single oral dose of a matching placebo capsule for moxifloxacin.

Placebo for Moxifloxacin Treatment B

Intervention Type DRUG

Days 2 and 15: Single oral dose of a matching placebo capsule of moxifloxacin.

Moxifloxacin Treatment C

Intervention Type DRUG

Day 2: A single oral dose of 400 mg moxifloxacin capsule.

Placebo for Moxifloxacin Treatment C

Intervention Type DRUG

Day 15: A single oral dose of a matching placebo capsule for moxifloxacin.

Treatment Sequence 3: B, A, C

Group Type EXPERIMENTAL

Balovaptan therapeutic dose Treatment A

Intervention Type DRUG

Days 1-14: A single once daily dose at dose level A of balovaptan for 14 days

Balovaptan supra-therapeutic dose Treatment B

Intervention Type DRUG

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

Intervention Type DRUG

Day 2: A single oral dose of 400 mg moxifloxacin capsule.

Placebo for Balovaptan Treatment C

Intervention Type DRUG

Days 1-14: Matching placebo for balovaptan for 14 days.

Placebo for Moxifloxacin Treatment A

Intervention Type DRUG

Day 2 and 15: A single oral dose of a matching placebo capsule for moxifloxacin.

Placebo for Moxifloxacin Treatment B

Intervention Type DRUG

Days 2 and 15: Single oral dose of a matching placebo capsule of moxifloxacin.

Moxifloxacin Treatment C

Intervention Type DRUG

Day 2: A single oral dose of 400 mg moxifloxacin capsule.

Placebo for Moxifloxacin Treatment C

Intervention Type DRUG

Day 15: A single oral dose of a matching placebo capsule for moxifloxacin.

Treatment Sequence 4: B, C, A

Group Type EXPERIMENTAL

Balovaptan therapeutic dose Treatment A

Intervention Type DRUG

Days 1-14: A single once daily dose at dose level A of balovaptan for 14 days

Balovaptan supra-therapeutic dose Treatment B

Intervention Type DRUG

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

Intervention Type DRUG

Day 2: A single oral dose of 400 mg moxifloxacin capsule.

Placebo for Balovaptan Treatment C

Intervention Type DRUG

Days 1-14: Matching placebo for balovaptan for 14 days.

Placebo for Moxifloxacin Treatment A

Intervention Type DRUG

Day 2 and 15: A single oral dose of a matching placebo capsule for moxifloxacin.

Placebo for Moxifloxacin Treatment B

Intervention Type DRUG

Days 2 and 15: Single oral dose of a matching placebo capsule of moxifloxacin.

Moxifloxacin Treatment C

Intervention Type DRUG

Day 2: A single oral dose of 400 mg moxifloxacin capsule.

Placebo for Moxifloxacin Treatment C

Intervention Type DRUG

Day 15: A single oral dose of a matching placebo capsule for moxifloxacin.

Treatment Sequence 5: C, A, B

Group Type EXPERIMENTAL

Balovaptan therapeutic dose Treatment A

Intervention Type DRUG

Days 1-14: A single once daily dose at dose level A of balovaptan for 14 days

Balovaptan supra-therapeutic dose Treatment B

Intervention Type DRUG

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

Intervention Type DRUG

Day 2: A single oral dose of 400 mg moxifloxacin capsule.

Placebo for Balovaptan Treatment C

Intervention Type DRUG

Days 1-14: Matching placebo for balovaptan for 14 days.

Placebo for Moxifloxacin Treatment A

Intervention Type DRUG

Day 2 and 15: A single oral dose of a matching placebo capsule for moxifloxacin.

Placebo for Moxifloxacin Treatment B

Intervention Type DRUG

Days 2 and 15: Single oral dose of a matching placebo capsule of moxifloxacin.

Moxifloxacin Treatment C

Intervention Type DRUG

Day 2: A single oral dose of 400 mg moxifloxacin capsule.

Placebo for Moxifloxacin Treatment C

Intervention Type DRUG

Day 15: A single oral dose of a matching placebo capsule for moxifloxacin.

Treatment Sequence 6: C, B, A

Group Type EXPERIMENTAL

Balovaptan therapeutic dose Treatment A

Intervention Type DRUG

Days 1-14: A single once daily dose at dose level A of balovaptan for 14 days

Balovaptan supra-therapeutic dose Treatment B

Intervention Type DRUG

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

Intervention Type DRUG

Day 2: A single oral dose of 400 mg moxifloxacin capsule.

Placebo for Balovaptan Treatment C

Intervention Type DRUG

Days 1-14: Matching placebo for balovaptan for 14 days.

Placebo for Moxifloxacin Treatment A

Intervention Type DRUG

Day 2 and 15: A single oral dose of a matching placebo capsule for moxifloxacin.

Placebo for Moxifloxacin Treatment B

Intervention Type DRUG

Days 2 and 15: Single oral dose of a matching placebo capsule of moxifloxacin.

Moxifloxacin Treatment C

Intervention Type DRUG

Day 2: A single oral dose of 400 mg moxifloxacin capsule.

Placebo for Moxifloxacin Treatment C

Intervention Type DRUG

Day 15: A single oral dose of a matching placebo capsule for moxifloxacin.

Treatment Sequence 7: A, B, D

Group Type EXPERIMENTAL

Balovaptan therapeutic dose Treatment A

Intervention Type DRUG

Days 1-14: A single once daily dose at dose level A of balovaptan for 14 days

Balovaptan supra-therapeutic dose Treatment B

Intervention Type DRUG

Days 1-14: A single once daily oral dose at dose level B of balovaptan for 14 days.

Active control [Moxifloxacin] on Day 15 Treatment D

Intervention Type DRUG

Day 15: A single oral dose of 400 mg moxifloxacin capsule.

Placebo for Balovaptan Treatment D

Intervention Type DRUG

Days 1-14: Matching placebo for balovaptan for 14 days.

Placebo for Moxifloxacin Treatment A

Intervention Type DRUG

Day 2 and 15: A single oral dose of a matching placebo capsule for moxifloxacin.

Placebo for Moxifloxacin Treatment B

Intervention Type DRUG

Days 2 and 15: Single oral dose of a matching placebo capsule of moxifloxacin.

Placebo for Moxifloxacin Treatment D

Intervention Type DRUG

Day 2: A single oral dose of a matching placebo capsule for moxifloxacin.

Moxifloxacin Treatment D

Intervention Type DRUG

Day 15: A single oral dose of 400 mg moxifloxacin capsule.

Treatment Sequence 8: A, D, B

Group Type EXPERIMENTAL

Balovaptan therapeutic dose Treatment A

Intervention Type DRUG

Days 1-14: A single once daily dose at dose level A of balovaptan for 14 days

Balovaptan supra-therapeutic dose Treatment B

Intervention Type DRUG

Days 1-14: A single once daily oral dose at dose level B of balovaptan for 14 days.

Active control [Moxifloxacin] on Day 15 Treatment D

Intervention Type DRUG

Day 15: A single oral dose of 400 mg moxifloxacin capsule.

Placebo for Balovaptan Treatment D

Intervention Type DRUG

Days 1-14: Matching placebo for balovaptan for 14 days.

Placebo for Moxifloxacin Treatment A

Intervention Type DRUG

Day 2 and 15: A single oral dose of a matching placebo capsule for moxifloxacin.

Placebo for Moxifloxacin Treatment B

Intervention Type DRUG

Days 2 and 15: Single oral dose of a matching placebo capsule of moxifloxacin.

Placebo for Moxifloxacin Treatment D

Intervention Type DRUG

Day 2: A single oral dose of a matching placebo capsule for moxifloxacin.

Moxifloxacin Treatment D

Intervention Type DRUG

Day 15: A single oral dose of 400 mg moxifloxacin capsule.

Treatment Sequence 9: B, A, D

Group Type EXPERIMENTAL

Balovaptan therapeutic dose Treatment A

Intervention Type DRUG

Days 1-14: A single once daily dose at dose level A of balovaptan for 14 days

Balovaptan supra-therapeutic dose Treatment B

Intervention Type DRUG

Days 1-14: A single once daily oral dose at dose level B of balovaptan for 14 days.

Active control [Moxifloxacin] on Day 15 Treatment D

Intervention Type DRUG

Day 15: A single oral dose of 400 mg moxifloxacin capsule.

Placebo for Balovaptan Treatment D

Intervention Type DRUG

Days 1-14: Matching placebo for balovaptan for 14 days.

Placebo for Moxifloxacin Treatment A

Intervention Type DRUG

Day 2 and 15: A single oral dose of a matching placebo capsule for moxifloxacin.

Placebo for Moxifloxacin Treatment B

Intervention Type DRUG

Days 2 and 15: Single oral dose of a matching placebo capsule of moxifloxacin.

Placebo for Moxifloxacin Treatment D

Intervention Type DRUG

Day 2: A single oral dose of a matching placebo capsule for moxifloxacin.

Moxifloxacin Treatment D

Intervention Type DRUG

Day 15: A single oral dose of 400 mg moxifloxacin capsule.

Treatment Sequence 10: B, D, A

Group Type EXPERIMENTAL

Balovaptan therapeutic dose Treatment A

Intervention Type DRUG

Days 1-14: A single once daily dose at dose level A of balovaptan for 14 days

Balovaptan supra-therapeutic dose Treatment B

Intervention Type DRUG

Days 1-14: A single once daily oral dose at dose level B of balovaptan for 14 days.

Active control [Moxifloxacin] on Day 15 Treatment D

Intervention Type DRUG

Day 15: A single oral dose of 400 mg moxifloxacin capsule.

Placebo for Balovaptan Treatment D

Intervention Type DRUG

Days 1-14: Matching placebo for balovaptan for 14 days.

Placebo for Moxifloxacin Treatment A

Intervention Type DRUG

Day 2 and 15: A single oral dose of a matching placebo capsule for moxifloxacin.

Placebo for Moxifloxacin Treatment B

Intervention Type DRUG

Days 2 and 15: Single oral dose of a matching placebo capsule of moxifloxacin.

Placebo for Moxifloxacin Treatment D

Intervention Type DRUG

Day 2: A single oral dose of a matching placebo capsule for moxifloxacin.

Moxifloxacin Treatment D

Intervention Type DRUG

Day 15: A single oral dose of 400 mg moxifloxacin capsule.

Treatment Sequence 11: D, A, B

Group Type EXPERIMENTAL

Balovaptan therapeutic dose Treatment A

Intervention Type DRUG

Days 1-14: A single once daily dose at dose level A of balovaptan for 14 days

Balovaptan supra-therapeutic dose Treatment B

Intervention Type DRUG

Days 1-14: A single once daily oral dose at dose level B of balovaptan for 14 days.

Active control [Moxifloxacin] on Day 15 Treatment D

Intervention Type DRUG

Day 15: A single oral dose of 400 mg moxifloxacin capsule.

Placebo for Balovaptan Treatment D

Intervention Type DRUG

Days 1-14: Matching placebo for balovaptan for 14 days.

Placebo for Moxifloxacin Treatment A

Intervention Type DRUG

Day 2 and 15: A single oral dose of a matching placebo capsule for moxifloxacin.

Placebo for Moxifloxacin Treatment B

Intervention Type DRUG

Days 2 and 15: Single oral dose of a matching placebo capsule of moxifloxacin.

Placebo for Moxifloxacin Treatment D

Intervention Type DRUG

Day 2: A single oral dose of a matching placebo capsule for moxifloxacin.

Moxifloxacin Treatment D

Intervention Type DRUG

Day 15: A single oral dose of 400 mg moxifloxacin capsule.

Treatment Sequence 12: D, B, A

Group Type EXPERIMENTAL

Balovaptan therapeutic dose Treatment A

Intervention Type DRUG

Days 1-14: A single once daily dose at dose level A of balovaptan for 14 days

Balovaptan supra-therapeutic dose Treatment B

Intervention Type DRUG

Days 1-14: A single once daily oral dose at dose level B of balovaptan for 14 days.

Active control [Moxifloxacin] on Day 15 Treatment D

Intervention Type DRUG

Day 15: A single oral dose of 400 mg moxifloxacin capsule.

Placebo for Balovaptan Treatment D

Intervention Type DRUG

Days 1-14: Matching placebo for balovaptan for 14 days.

Placebo for Moxifloxacin Treatment A

Intervention Type DRUG

Day 2 and 15: A single oral dose of a matching placebo capsule for moxifloxacin.

Placebo for Moxifloxacin Treatment B

Intervention Type DRUG

Days 2 and 15: Single oral dose of a matching placebo capsule of moxifloxacin.

Placebo for Moxifloxacin Treatment D

Intervention Type DRUG

Day 2: A single oral dose of a matching placebo capsule for moxifloxacin.

Moxifloxacin Treatment D

Intervention Type DRUG

Day 15: A single oral dose of 400 mg moxifloxacin capsule.

Interventions

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Balovaptan therapeutic dose Treatment A

Days 1-14: A single once daily dose at dose level A of balovaptan for 14 days

Intervention Type 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.

Intervention Type DRUG

Active control [moxifloxacin] on Day 2 Treatment C

Day 2: A single oral dose of 400 mg moxifloxacin capsule.

Intervention Type DRUG

Active control [Moxifloxacin] on Day 15 Treatment D

Day 15: A single oral dose of 400 mg moxifloxacin capsule.

Intervention Type DRUG

Placebo for Balovaptan Treatment C

Days 1-14: Matching placebo for balovaptan for 14 days.

Intervention Type DRUG

Placebo for Balovaptan Treatment D

Days 1-14: Matching placebo for balovaptan for 14 days.

Intervention Type DRUG

Placebo for Moxifloxacin Treatment A

Day 2 and 15: A single oral dose of a matching placebo capsule for moxifloxacin.

Intervention Type DRUG

Placebo for Moxifloxacin Treatment B

Days 2 and 15: Single oral dose of a matching placebo capsule of moxifloxacin.

Intervention Type DRUG

Moxifloxacin Treatment C

Day 2: A single oral dose of 400 mg moxifloxacin capsule.

Intervention Type DRUG

Placebo for Moxifloxacin Treatment C

Day 15: A single oral dose of a matching placebo capsule for moxifloxacin.

Intervention Type DRUG

Placebo for Moxifloxacin Treatment D

Day 2: A single oral dose of a matching placebo capsule for moxifloxacin.

Intervention Type DRUG

Moxifloxacin Treatment D

Day 15: A single oral dose of 400 mg moxifloxacin capsule.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes