Clinical Pharmacology of FYU-981 (Effect on QT/QTc Interval)
Phase 2
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT02515864
- Lead Sponsor
- Fuji Yakuhin Co., Ltd.
- Brief Summary
A Placebo-controlled, Four Way Crossover Study to Investigate the Effect on QT/QTc Interval of a Single Dose of FYU-981, Compared with Placebo, Using Moxifloxacin as a Positive Control, in Healthy Male and Female Volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
- Japanese adult subjects
- Body mass index: >=18.5 and <27.5
Exclusion Criteria
- Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Moxifloxacin Placebo Drug: FYU-981 Placebo, Moxifloxacin Placebo (Oral) FYU-981 anticipated therapeutic dose FYU-981 Drug: FYU-981, FYU-981 Placebo, Moxifloxacin Placebo (Oral) FYU-981 anticipated therapeutic dose Placebo Drug: FYU-981, FYU-981 Placebo, Moxifloxacin Placebo (Oral) FYU-981 anticipated therapeutic dose Moxifloxacin Placebo Drug: FYU-981, FYU-981 Placebo, Moxifloxacin Placebo (Oral) FYU-981 supratherapeutic dose FYU-981 Drug: FYU-981, Moxifloxacin Placebo (Oral) FYU-981 supratherapeutic dose Moxifloxacin Placebo Drug: FYU-981, Moxifloxacin Placebo (Oral) Placebo Placebo Drug: FYU-981 Placebo, Moxifloxacin Placebo (Oral) Moxifloxacin Placebo Drug: Moxifloxacin, FYU-981 Placebo (Oral) Moxifloxacin Moxifloxacin Drug: Moxifloxacin, FYU-981 Placebo (Oral)
- Primary Outcome Measures
Name Time Method QT/QTc Interval 24 hours
- Secondary Outcome Measures
Name Time Method