Phase I Study of OPC-61815
A Single-center, Randomized, Double-blind (for OPC-61815 and Placebo), Placebo- and Moxifloxacin Positive-controlled, 4-Period Crossover Trial to Evaluate the Effect of Single Intravenous Administration of OPC-61815 at 16 and 32 mg on QT/QTc Interval in Healthy Male Subjects
2 other identifiers
interventional
48
1 country
1
Brief Summary
To investigate the effects of intravenous administration of OPC-61815 at 16 and 32 mg on QT/QTc interval in healthy male 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
Started May 2018
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 18, 2018
CompletedFirst Posted
Study publicly available on registry
April 27, 2018
CompletedStudy Start
First participant enrolled
May 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 5, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 5, 2018
CompletedResults Posted
Study results publicly available
May 10, 2021
CompletedMay 10, 2021
April 1, 2021
2 months
April 18, 2018
March 12, 2021
April 13, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Time-matched Difference Between the OPC-61815/Moxifloxacin and Placebo Data in Change From Baseline for QTcF in 12-lead Holter Electrocardiogram (ECG)
For each OPC-61815 dose, the upper limit of the confidence interval (CI) for the time-matched difference in the least squares (LS) mean for the change in QT corrected for heart rate by Fridericia's formula (QTcF) from baseline compared to the placebo data was evaluated to determine if it was lower than 10 msec at all postdose time points. Using a linear mixed effect model with baseline QTcF in each treatment period as a covariate, treatment, sequence, treatment period, time point, and interaction between treatment and time point as fixed effects, and subject as a random effect, point estimates and CIs for the time-matched difference in the LS mean for the change in QTcF from baseline compared to the placebo data were calculated.
Baseline, 1h, 1.5h, 2h, 3h, 4h, 6h, 12h, 24h after dosing
Study Arms (4)
OPC-61815 16mg
EXPERIMENTALOPC-61815 16mg will be intravenously administered once a week.
OPC-61815 32mg
EXPERIMENTALOPC-61815 32mg will be intravenously administered once a week.
Moxifloxacin
ACTIVE COMPARATOR400mg tablet will be administrated once a week.
Placebo
PLACEBO COMPARATORPlacebo will be intravenously administered once a week.
Interventions
Eligibility Criteria
You may qualify if:
- Body mass index (BMI) \[body weight in kg / (height in m)2\] of at least 18.5 kg/m2 and less than 25.0 kg/m2 as a result of at the screening examination
- Judged by the investigator or subinvestigator to be capable of providing written informed consent prior to start of any trial-related procedures and capable of complying with the procedures for this trial
You may not qualify if:
- Subjects with a medical history of convulsive disorder, long QT syndrome (including family history), syncope during swimming, or any other type of syncope or cryptogenic loss of consciousness
- Subjects with a serum electrolyte abnormality (hypokalemia, hypomagnesemia, hypocalcemia, etc)
- Subjects with a family history of sudden death
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kyusyu Region
Fukuoka, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Clinical Trials
- Organization
- Otsuka Pharmaceutical Co., LTD.
Study Officials
- STUDY DIRECTOR
Osamu Sato
Otsuka Pharmaceutical Co., Ltd.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
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
April 18, 2018
First Posted
April 27, 2018
Study Start
May 8, 2018
Primary Completion
July 5, 2018
Study Completion
July 5, 2018
Last Updated
May 10, 2021
Results First Posted
May 10, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share