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OpenTrials
Completed

NCT Number: NCT03808298

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

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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Key information

Conditions

Healthy Volunteers

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRA International Clinical Pharmacology Center (EDS US Clinic)

Lenexa, Kansas, 66219, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Balovaptan therapeutic dose Treatment A

Drug

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

Balovaptan supra-therapeutic dose Treatment B

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

Drug

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

Active control [Moxifloxacin] on Day 15 Treatment D

Drug

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

Placebo for Balovaptan Treatment C

Drug

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

Placebo for Balovaptan Treatment D

Drug

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

Placebo for Moxifloxacin Treatment A

Drug

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

Placebo for Moxifloxacin Treatment B

Drug

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

Moxifloxacin Treatment C

Drug

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

Placebo for Moxifloxacin Treatment C

Drug

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

Placebo for Moxifloxacin Treatment D

Drug

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

Moxifloxacin Treatment D

Drug

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

Primary outcomes

  1. Change-From-Baseline QTcF at Dose Level B Measured on 12-Lead ECGs Extracted From Continuous Recordings

    Time frame: Baseline (Predose Day 1), Day 14. (Each treatment period is 15 days.)

    Change-from-baseline QTcF (ΔΔQTcF) at dose level B of balovaptan measured on 12-lead ECGs extracted from continuous recordings at the specified time points on Day 14.

Secondary outcomes

  1. Change-From-Baseline QTcF at Dose Level B Measured on 12-Lead ECGs Extracted From Continuous Recordings

    Time frame: Baseline (Predose Day 1), Day 1. (Each treatment period is 15 days.)

    Change-from-baseline QTcF (ΔΔQTcF) at dose level B of balovaptan measured on 12-lead ECGs extracted from continuous recordings at the specified time points on Day 1.

  2. Change-From-Baseline QTcF of Balovaptan at Dose Level A Measurred on 12-Lead ECGs Extracted From Continuous Recordings

    Time frame: Baseline (Predose Day 1), Day 1 and Day 14. (Each treatment period is 15 days.)

    Change-from-baseline QTcF (ΔΔQTcF) at dose level A of balovaptan measured on 12-lead ECGs extracted from continuous recordings at the specified time points on Days 1 and 14.

  3. Change-From-Baseline Heart Rate Measured on 12-Lead ECGs Extracted From Continuous Recordings

    Time frame: Baseline (Predose Day 1), Day 1 and Day 14. (Each treatment period is 15 days.)

    Change-from-baseline heart rate at dose level A and dose level B of balovaptan measured on 12-Lead ECGs extracted from continuous recordings on Days 1 and 14.

  4. Change-From-Baseline PR Interval Measured on 12-Lead ECGs Extracted From Continuous Recordings

    Time frame: Baseline (Predose Day 1), Day 1 and Day 14. (Each treatment period is 15 days.)

    Change-from-baseline PR interval at dose level A and dose level B of balovaptan measured on 12-Lead ECGs extracted from continuous recordings on Day 1 and 14.

  5. Change-From-Baseline QRS Interval Measured on 12-Lead ECGs Extracted From Continuous Recordings

    Time frame: Baseline (Predose Day 1), Day 1 and Day 14. (Each treatment period is 15 days.)

    Change-from-baseline QRS interval at dose level A and dose level B of balovapton measured on 12-Lead ECGs extracted from continuous recordings on Days 1 and 14.

  6. Number of Categorical Outliers for QTcF

    Time frame: Up to approximately 20 weeks

    The number (percentage) of categorical outliers were participants who had increases in absolute QTcF values > 450 and ≤ 480 ms, > 480 and ≤ 500 ms, or > 500 ms.

  7. Number of Categorical Outliers for HR

    Time frame: Up to approximately 20 weeks

    Number (percentage) of categorical outliers were participants with a decrease in HR from pre-dose baseline > 25% to a HR < 50 bpm; and increase in HR from pre-dose baseline > 25% to a HR > 100 bpm.

  8. Number of Categorical Outliers for PR

    Time frame: Up to approximately 20 weeks

    PR outliers criteria is as an increase of PR from baseline >25% resulting in PR >200 ms.

  9. Number of Categorical Outliers for QRS

    Time frame: Up to approximately 20 weeks

    QRS outlier criteria is an increase of QRS from baseline >25% resulting in QRS >120 ms.

  10. Number of Treatment Emergent Changes of T-Wave Morphology

    Time frame: Up to approximately 20 weeks

    Number (%) of participants falling into each of the T-wave categories: Normal (+), Flat, Notched (+), Biphasic, Normal (-), Notched (-).

  11. Number of Treatment Emergent Changes of U-Wave Presence

    Time frame: Up to approximately 20 weeks

    Number (percentage) of participants with treatment emergent changes of U-wave presence.

  12. Tmax of Balovaptan

    Time frame: Day 1 and Day 14. (Each treatment period is 15 days.)

  13. Tmax of M2 Metabolite

    Time frame: Day 1 and Day 14. (Each treatment period is 15 days.)

  14. Tmax M3 Metabolite

    Time frame: Day 1 and Day 14. (Each treatment period is 15 days.)

  15. Cmax of Balovaptan

    Time frame: Day 1 and Day 14. (Each treatment period is 15 days.)

  16. Cmax of M2 Metabolite

    Time frame: Day 1 and Day 14. (Each treatment period is 15 days.)

  17. Cmax of M3 Metabolite

    Time frame: Day 1 and Day 14. (Each treatment period is 15 days.)

  18. AUC0-24 of Balovaptan

    Time frame: Day 1 and Day 14 (Each treatment period is 15 days.)

  19. AUC0-24 of M2 Metabolite

    Time frame: Day 1 and Day 14 (Each treatment period is 15 days.)

  20. AUC0-24 of M3 Metabolite

    Time frame: Day 1 and Day 14 (Each treatment period is 15 days.)

  21. Tmax of Moxifloxacin

    Time frame: Days 2 (Treatment C) or 15 (Treatment D). (Each treatment period is 15 days.)

  22. Cmax of Moxifloxacin

    Time frame: Days 2 (Treatment C) or 15 (Treatment D) (Each treatment period is 15 days.)

  23. AUC0-24 of Moxifloxacin

    Time frame: Days 2 (Treatment C) or 15 (Treatment D) (Each treatment period is 15 days.)

  24. Predicted ΔΔQTcF Interval at Geometric Mean Peak Concentrations at Tmax of Balovaptan From Concentration-QTc Analysis

    Time frame: Baseline, Day 14. (Each treatment period is 15 days.)

  25. Predicted ΔΔQTcF Interval at Geometric Mean Peak Concentrations at Tmax of M2 From Concentration-QTc Analysis

    Time frame: Baseline, Day 14. (Each treatment period is 15 days.)

  26. Predicted ΔΔQTcF Interval at Geometric Mean Peak Concentration for M3 From Concentration-QTc Analysis

    Time frame: Baseline, Day 14. (Each treatment period is 15 days.)

  27. Change-From-Baseline QTcF Measured on 12 Lead ECGs Extracted From Continuous Records

    Time frame: Baseline, Day 15. (Each treatment period is 15 days.)

  28. Percentage of Participants With Treatment Emergent Adverse Events

    Time frame: Up to approximately 20 weeks.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 17, 2019
Registry last updated
Jul 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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