Clinical Pharmacology of FYU-981 (Effect on QT/QTc Interval)

Fuji Yakuhin

Status and phase: Completed; Phase 2

Conditions: Healthy

Treatments: Drug: Placebo; Drug: FYU-981; Drug: Moxifloxacin Placebo; Drug: Moxifloxacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02515864

FYU-981-007

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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48 participants in 4 patient groups, including a placebo group

FYU-981 anticipated therapeutic dose

Experimental group

Description:

Drug: FYU-981, FYU-981 Placebo, Moxifloxacin Placebo (Oral)

Treatment:

Drug: FYU-981

Drug: Moxifloxacin Placebo

Drug: Placebo

FYU-981 supratherapeutic dose

Experimental group

Description:

Drug: FYU-981, Moxifloxacin Placebo (Oral)

Treatment:

Drug: FYU-981

Drug: Moxifloxacin Placebo

Placebo

Placebo Comparator group

Description:

Drug: FYU-981 Placebo, Moxifloxacin Placebo (Oral)

Treatment:

Drug: Moxifloxacin Placebo

Drug: Placebo

Moxifloxacin

Active Comparator group

Description:

Drug: Moxifloxacin, FYU-981 Placebo (Oral)

Treatment:

Drug: Placebo

Drug: Moxifloxacin