atherosclerotic diseases
Conditions
Interventions
investigational material(s)
Generic name etc : LPC-01
INN of investigational material :
Therapeutic category code : 218 Agents for hyperlipidemias
Dosage and Administration for Investigational materi
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Japanese
Exclusion criteria
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
Outcome results
None listed