Japanese healthy male subjects
Conditions
Sponsors
Nihon Medi-Physics Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Have no history or symptoms of disease that would interfere with the evaluation the subjects, and no clinically significant deviation from normal ranges in screening tests (medical history, physical examination, ECG and clinical laboratory tests (hematology, biochemistry and urinalysis)). 2.Expected ability to perform a treadmill exercise stress testing sufficiently to achieve more than 85% of age-predicted maximum heart rate (APMHR). (For cohort 1 subjects) 3.Have a body mass index (BMI) of 18 to 28 at the time of screening.
Exclusion criteria
Exclusion criteria: 1. Be contracting a disease or having trauma that may affect pharmacokinetics. 2. Have a history of prior allergic response to any drugs. 3. Be presence of any contraindications (absolute or relative) to exercise stress testing. (For cohort 1subjects) 4. Be presence of any contraindications to pharmacologic stress testing with adenosine or administration of aminophylline. (For cohort 2 subjects)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety AEs, vital signs, ECGs, clinical laboratory tests and physical examinations. | — |
Secondary
| Measure | Time frame |
|---|---|
| other pharmacokinetics To assess the radiokinetics of NMB58 in healthy subjects under rest and stress conditions. To estimate the radiation dosimetry of NMB58 in healthy subjects under rest and stress conditions. | — |
Countries
Japan
Outcome results
None listed