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.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223728

Enrollment

Registered

2017-11-22

Start date

2011-08-11

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Part A and B Healthy adult male subjects Part C Adult subjects with spontaneous bowel movements 3 times or less a week

Interventions

investigational material(s) Generic name etc : DSP-6952 INN of investigational material : minesapride Therapeutic category code : 239 Other agents affecting digestive organs Dosage and Administration

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Subjects with any history of diseases that might be unsuitable for participation in the clinical study etc.

Design outcomes

Primary

Measure	Time frame
safety Adverse events, adverse drug reactions, vital signs (pulse rate, blood pressure and body temperature), laboratory tests, and 12-lead electrocardiography	—

Secondary

Measure	Time frame
pharmacodynamics pharmacokinetics Pharmacokinetic assessments 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 conditions. No abnormal drug accumulation was observed with repeated administration. Pharmacodynamic assessments 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 and higher than that for placebo. The results suggest that DSP-6952 has effects on bowel movement.	—

Measure

Time frame

pharmacodynamics pharmacokinetics Pharmacokinetic assessments 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 conditions. No abnormal drug accumulation was observed with repeated administration. Pharmacodynamic assessments 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 and higher than that for placebo. The results suggest that DSP-6952 has effects on bowel movement.

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Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026