Phase 1
Completed N=48
Phase I Study of OPC-61815
Source: ClinicalTrials.gov NCT03510663 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
May 2021
Primary outcomePrimary: Time-matched Difference Between the OPC-61815/Moxifloxacin and Placebo Data in Change From Baseline for QTcF in 12-lead Holter Electrocardiogram (ECG) — 0.9; 0.0; 9.9; -0.9 msec
Summary
To investigate the effects of intravenous administration of OPC-61815 at 16 and 32 mg on QT/QTc interval in healthy male subjects
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time-matched Difference Between the OPC-61815/Moxifloxacin and Placebo Data in Change From Baseline for QTcF in 12-lead Holter Electrocardiogram (ECG) |
0.9; 0.0; 9.9; -0.9; 2.0; 1.3 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03510663). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.