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

  • Healthy Volunteers
Trial Status:

Completed

This trial runs in
Countries
  • United States
Trial Identifier:

NCT03808298 WP40734

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      Trial 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.

      Hoffmann-La Roche Sponsor
      Phase 1 Phase
      NCT03808298 , WP40734 Trial Identifier
      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 Treatments
      Healthy Volunteers Condition
      Official Title

      A Single-Center, Multiple-Dose, Randomized, Double-Blind, Placebo-Controlled, Cross-Over Study to Investigate the Effect of Balovaptan on the QTC Interval in Healthy Subjects

      Eligibility Criteria

      All Gender
      ≥18 Years & ≤ 60 Years Age
      Accepts Healthy Volunteers 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.

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