A single-dose ascending study and a multiple-dose study in healthy male subjects and a multiple-dose study in subjects who have no more than 3 spontaneous bowel movements per week to investigate the tolerability, safety, pharmacokinetics, and pharmacodynamics of DSP-6952, and a single-dose study in healthy male subjects to examine the effect of food.
Phase 1
Completed
- Conditions
- Part A and BHealthy adult male subjects Part CAdult subjects with spontaneous bowel movements 3 times or less a week
- Registration Number
- JPRN-jRCT2080223728
- Lead Sponsor
- Sumitomo Dainippon Pharma Co., Ltd.
- Brief Summary
DSP-6952 was well tolerated when administered as a single dose of 4 to 120 mg or multiple doses of 4 to 120 mg/day administered for 7 days with a dose-proportional pharmacokinetic profile. The PD assessments results suggested that DSP-6952 has effects on bowel movement.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 88
Inclusion Criteria
Part A and B
Healthy adult male subjects
Subjects who were aged 20 through 39 years at informed consent etc.
Part C
Adult male or female subjects with spontaneous bowel movements 3 times or less a week
Subjects who were aged 20 through 64 years at informed consent etc.
Exclusion Criteria
Subjects with any history of diseases that might be unsuitable for participation in the clinical study etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>Adverse events, adverse drug reactions, vital signs (pulse rate, blood pressure<br>and body temperature), laboratory tests, and 12-lead electrocardiography
- Secondary Outcome Measures
Name Time Method pharmacodynamics<br>pharmacokinetics<br>Pharmacokinetic assessments<br>Cmax and AUC of DSP-6952 were dose-proportional within a range of 4-120mg. Under fed conditions, the Cmax and AUC of DSP-6952 were approximately half those of fasting<br>conditions. No abnormal drug accumulation was observed with repeated administration.<br><br>Pharmacodynamic assessments<br>During multiple-dose administration to volunteers with spontaneous bowel movements under or equal to 3 times a week (Part C),the frequency of bowel movements increased for DSP-6952 and placebo. The increase for 4 and 40 mg of DSP-6952 was similar<br>and higher than that for placebo. The results suggest that DSP-6952 has<br>effects on bowel movement.