A Thorough Corrected QT Interval Trial

Kowa

Status and phase: Completed; Phase 1

Conditions: Dyslipidemia

Treatments: Drug: K-877 High Dose; Drug: K-877 Low Dose; Drug: Moxifloxacin; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02073084

K-877-102

Details and patient eligibility

About

The purpose of this study is to determine the effects of K-877 on ECG parameters with a focus on cardiac repolarization compared with placebo in healthy adult subjects.

Enrollment: 56 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject provides written informed consent before any study specific evaluation is performed.
• Subject is a healthy adult male or female volunteer, of any race and ethnicity, between the ages of 18 and 45 years, inclusive.
• Subject has a body mass index of 18 to 30 kg/m2, inclusive.

Exclusion criteria

• Subject has clinically relevant abnormalities in the screening or check in assessments.
• Subject has a supine blood pressure after resting for at least 5 minutes that is higher than 140 mm Hg systolic or 90 mm Hg diastolic, or lower than 90 mm Hg systolic or 60 mm Hg diastolic.
• Subject has a supine Heart Rate (HR) (as measured at Screening or Check-in during collection of vital signs) after resting for at least 5 minutes that is outside the range of 40 to 90 beats per minute.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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56 participants in 4 patient groups

Sequence A

Other group

Description:

Sequence A

Treatment:

Drug: Moxifloxacin

Drug: K-877 Low Dose

Other: Placebo

Drug: K-877 High Dose

Sequence B

Other group

Description:

Sequence B

Treatment:

Drug: Moxifloxacin

Drug: K-877 Low Dose

Other: Placebo

Drug: K-877 High Dose

Sequence C

Other group

Description:

Sequence C

Treatment:

Drug: Moxifloxacin

Drug: K-877 Low Dose

Other: Placebo

Drug: K-877 High Dose

Sequence D

Other group

Description:

Sequence D

Treatment:

Drug: Moxifloxacin

Drug: K-877 Low Dose

Other: Placebo

Drug: K-877 High Dose