Study to Investigate the Effect of Balovaptan on the QTC Interval in Healthy Subjects
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
1 other identifier
interventional
57
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy-volunteers
Started Feb 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 7, 2019
CompletedFirst Posted
Study publicly available on registry
January 17, 2019
CompletedStudy Start
First participant enrolled
February 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 14, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 13, 2019
CompletedResults Posted
Study results publicly available
July 24, 2020
CompletedJuly 24, 2020
July 1, 2020
4 months
January 7, 2019
June 2, 2020
July 8, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change-From-Baseline QTcF at Dose Level B Measured on 12-Lead ECGs Extracted From Continuous Recordings
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.
Baseline (Predose Day 1), Day 14. (Each treatment period is 15 days.)
Secondary Outcomes (28)
Change-From-Baseline QTcF at Dose Level B Measured on 12-Lead ECGs Extracted From Continuous Recordings
Baseline (Predose Day 1), Day 1. (Each treatment period is 15 days.)
Change-From-Baseline QTcF of Balovaptan at Dose Level A Measurred on 12-Lead ECGs Extracted From Continuous Recordings
Baseline (Predose Day 1), Day 1 and Day 14. (Each treatment period is 15 days.)
Change-From-Baseline Heart Rate Measured on 12-Lead ECGs Extracted From Continuous Recordings
Baseline (Predose Day 1), Day 1 and Day 14. (Each treatment period is 15 days.)
Change-From-Baseline PR Interval Measured on 12-Lead ECGs Extracted From Continuous Recordings
Baseline (Predose Day 1), Day 1 and Day 14. (Each treatment period is 15 days.)
Change-From-Baseline QRS Interval Measured on 12-Lead ECGs Extracted From Continuous Recordings
Baseline (Predose Day 1), Day 1 and Day 14. (Each treatment period is 15 days.)
- +23 more secondary outcomes
Study Arms (12)
Treatment Sequence 1: A, B, C
EXPERIMENTALTreatment Sequence 2: A, C, B
EXPERIMENTALTreatment Sequence 3: B, A, C
EXPERIMENTALTreatment Sequence 4: B, C, A
EXPERIMENTALTreatment Sequence 5: C, A, B
EXPERIMENTALTreatment Sequence 6: C, B, A
EXPERIMENTALTreatment Sequence 7: A, B, D
EXPERIMENTALTreatment Sequence 8: A, D, B
EXPERIMENTALTreatment Sequence 9: B, A, D
EXPERIMENTALTreatment Sequence 10: B, D, A
EXPERIMENTALTreatment Sequence 11: D, A, B
EXPERIMENTALTreatment Sequence 12: D, B, A
EXPERIMENTALInterventions
Days 1-14: A single once daily dose at dose level A of balovaptan for 14 days
Days 1-14: A single once daily oral dose at dose level B of balovaptan for 14 days.
Day 2: A single oral dose of 400 mg moxifloxacin capsule.
Day 15: A single oral dose of 400 mg moxifloxacin capsule.
Days 1-14: Matching placebo for balovaptan for 14 days.
Days 1-14: Matching placebo for balovaptan for 14 days.
Day 2 and 15: A single oral dose of a matching placebo capsule for moxifloxacin.
Days 2 and 15: Single oral dose of a matching placebo capsule of moxifloxacin.
Day 2: A single oral dose of 400 mg moxifloxacin capsule.
Day 15: A single oral dose of a matching placebo capsule for moxifloxacin.
Day 2: A single oral dose of a matching placebo capsule for moxifloxacin.
Day 15: A single oral dose of 400 mg moxifloxacin capsule.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PRA International Clinical Pharmacology Center (EDS US Clinic)
Lenexa, Kansas, 66219, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2019
First Posted
January 17, 2019
Study Start
February 7, 2019
Primary Completion
June 14, 2019
Study Completion
July 13, 2019
Last Updated
July 24, 2020
Results First Posted
July 24, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share