QT Interval Evaluation Study in Healthy Japanese Adult Male Subjects

Phase 1

• Conditions: atherosclerotic diseases

• Registration Number: JPRN-jRCT2080222322
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-10
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

1) Japanese

Exclusion Criteria

(Summary)
1) Subjects with hypersensitivity or a history of hypersensitivity to any drug (any prescription or over-the-counter drug)
2) Subjects who meet any of the following lipid criteria in the fasting state (at time of screening examination)
LDL cholesterol (LDL-C): 140 mg/dL and over 140 mg/dL
HDL cholesterol (HDL-C): less than 40 mg/dL
Triglyceride (TG): 150 mg/dL and over 150 mg/dL
3) Subjects with convulsive disorder, congenital long QT interval syndrome, or experience of syncope while swimming or history of syncope or loss of consciousness
4) Subjects with family history of sudden death
5) Subjects with serum electrolyte abnormality
6) Subjects with 12-lead ECG findings such as AV block, significant respiratory arrhythmia, frequent extrasystoles, or bundle branch block which may affect electrocardiographic analysis, or those with PR interval, QRS width, or QTcF interval with outside the following standard values
PR interval: between 100 msec to 220 msec
QRS width: 140 msec and under 140 msec
QTcF interval: between 330 msec to 440 msec

Study & Design

• Study Type: Interventional
• Study Design: Not specified