Phase I clinical study for safety and pharmacokinetic evaluation of NMB58 in Japanese healthy adult male
- Conditions
- Japanese healthy male subjects
- Registration Number
- jRCT2080224522
- Lead Sponsor
- Nihon Medi-Physics Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Male
- Target Recruitment
- 10
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.
- Be contracting a disease or having trauma that may affect pharmacokinetics.
- Have a history of prior allergic response to any drugs.
- Be presence of any contraindications (absolute or relative) to exercise stress testing. (For cohort 1subjects)
- Be presence of any contraindications to pharmacologic stress testing with adenosine or administration of aminophylline. (For cohort 2 subjects)
Study & Design
- Study Type
- Interventional
- Study Design
- non-randomized, open-label
- Primary Outcome Measures
Name Time Method - safety
AEs, vital signs, ECGs, clinical laboratory tests and physical examinations.
- Secondary Outcome Measures
Name Time Method radiokinetics of NMB58 To assess the radiokinetics of NMB58 in healthy subjects under rest and stress conditions.
radiation dosimetry of NMB58 To estimate the radiation dosimetry of NMB58 in healthy subjects under rest and stress conditions.
Trial Locations
- Locations (1)
Japan
Location not specified
Japan