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

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03808298

WP40734

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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57 participants in 12 patient groups

Treatment Sequence 1: A, B, C

Experimental group

Treatment:

Drug: Placebo for Moxifloxacin Treatment B

Drug: Balovaptan therapeutic dose Treatment A

Drug: Moxifloxacin Treatment C

Drug: Balovaptan supra-therapeutic dose Treatment B

Drug: Placebo for Moxifloxacin Treatment C

Drug: Placebo for Moxifloxacin Treatment A

Drug: Placebo for Balovaptan Treatment C

Drug: Active control [moxifloxacin] on Day 2 Treatment C

Treatment Sequence 2: A, C, B

Experimental group

Treatment:

Drug: Placebo for Moxifloxacin Treatment B

Drug: Balovaptan therapeutic dose Treatment A

Drug: Moxifloxacin Treatment C

Drug: Balovaptan supra-therapeutic dose Treatment B

Drug: Placebo for Moxifloxacin Treatment C

Drug: Placebo for Moxifloxacin Treatment A

Drug: Placebo for Balovaptan Treatment C

Drug: Active control [moxifloxacin] on Day 2 Treatment C

Treatment Sequence 3: B, A, C

Experimental group

Treatment:

Drug: Placebo for Moxifloxacin Treatment B

Drug: Balovaptan therapeutic dose Treatment A

Drug: Moxifloxacin Treatment C

Drug: Balovaptan supra-therapeutic dose Treatment B

Drug: Placebo for Moxifloxacin Treatment C

Drug: Placebo for Moxifloxacin Treatment A

Drug: Placebo for Balovaptan Treatment C

Drug: Active control [moxifloxacin] on Day 2 Treatment C

Treatment Sequence 4: B, C, A

Experimental group

Treatment:

Drug: Placebo for Moxifloxacin Treatment B

Drug: Balovaptan therapeutic dose Treatment A

Drug: Moxifloxacin Treatment C

Drug: Balovaptan supra-therapeutic dose Treatment B

Drug: Placebo for Moxifloxacin Treatment C

Drug: Placebo for Moxifloxacin Treatment A

Drug: Placebo for Balovaptan Treatment C

Drug: Active control [moxifloxacin] on Day 2 Treatment C

Treatment Sequence 5: C, A, B

Experimental group

Treatment:

Drug: Placebo for Moxifloxacin Treatment B

Drug: Balovaptan therapeutic dose Treatment A

Drug: Moxifloxacin Treatment C

Drug: Balovaptan supra-therapeutic dose Treatment B

Drug: Placebo for Moxifloxacin Treatment C

Drug: Placebo for Moxifloxacin Treatment A

Drug: Placebo for Balovaptan Treatment C

Drug: Active control [moxifloxacin] on Day 2 Treatment C

Treatment Sequence 6: C, B, A

Experimental group

Treatment:

Drug: Placebo for Moxifloxacin Treatment B

Drug: Balovaptan therapeutic dose Treatment A

Drug: Moxifloxacin Treatment C

Drug: Balovaptan supra-therapeutic dose Treatment B

Drug: Placebo for Moxifloxacin Treatment C

Drug: Placebo for Moxifloxacin Treatment A

Drug: Placebo for Balovaptan Treatment C

Drug: Active control [moxifloxacin] on Day 2 Treatment C

Treatment Sequence 7: A, B, D

Experimental group

Treatment:

Drug: Moxifloxacin Treatment D

Drug: Placebo for Moxifloxacin Treatment B

Drug: Balovaptan therapeutic dose Treatment A

Drug: Placebo for Moxifloxacin Treatment D

Drug: Placebo for Balovaptan Treatment D

Drug: Active control [Moxifloxacin] on Day 15 Treatment D

Drug: Balovaptan supra-therapeutic dose Treatment B

Drug: Placebo for Moxifloxacin Treatment A

Treatment Sequence 8: A, D, B

Experimental group

Treatment:

Drug: Moxifloxacin Treatment D

Drug: Placebo for Moxifloxacin Treatment B

Drug: Balovaptan therapeutic dose Treatment A

Drug: Placebo for Moxifloxacin Treatment D

Drug: Placebo for Balovaptan Treatment D

Drug: Active control [Moxifloxacin] on Day 15 Treatment D

Drug: Balovaptan supra-therapeutic dose Treatment B

Drug: Placebo for Moxifloxacin Treatment A

Treatment Sequence 9: B, A, D

Experimental group

Treatment:

Drug: Moxifloxacin Treatment D

Drug: Placebo for Moxifloxacin Treatment B

Drug: Balovaptan therapeutic dose Treatment A

Drug: Placebo for Moxifloxacin Treatment D

Drug: Placebo for Balovaptan Treatment D

Drug: Active control [Moxifloxacin] on Day 15 Treatment D

Drug: Balovaptan supra-therapeutic dose Treatment B

Drug: Placebo for Moxifloxacin Treatment A

Treatment Sequence 10: B, D, A

Experimental group

Treatment:

Drug: Moxifloxacin Treatment D

Drug: Placebo for Moxifloxacin Treatment B

Drug: Balovaptan therapeutic dose Treatment A

Drug: Placebo for Moxifloxacin Treatment D

Drug: Placebo for Balovaptan Treatment D

Drug: Active control [Moxifloxacin] on Day 15 Treatment D

Drug: Balovaptan supra-therapeutic dose Treatment B

Drug: Placebo for Moxifloxacin Treatment A

Treatment Sequence 11: D, A, B

Experimental group

Treatment:

Drug: Moxifloxacin Treatment D

Drug: Placebo for Moxifloxacin Treatment B

Drug: Balovaptan therapeutic dose Treatment A

Drug: Placebo for Moxifloxacin Treatment D

Drug: Placebo for Balovaptan Treatment D

Drug: Active control [Moxifloxacin] on Day 15 Treatment D

Drug: Balovaptan supra-therapeutic dose Treatment B

Drug: Placebo for Moxifloxacin Treatment A

Treatment Sequence 12: D, B, A

Experimental group

Treatment:

Drug: Moxifloxacin Treatment D

Drug: Placebo for Moxifloxacin Treatment B

Drug: Balovaptan therapeutic dose Treatment A

Drug: Placebo for Moxifloxacin Treatment D

Drug: Placebo for Balovaptan Treatment D

Drug: Active control [Moxifloxacin] on Day 15 Treatment D

Drug: Balovaptan supra-therapeutic dose Treatment B

Drug: Placebo for Moxifloxacin Treatment A