臨床研究等提出・公開システム

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.

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.

88

Part A The mean age ranged from 24.5 to 26.7 years in the different dose groups, and the mean body weight from 59.82 to 66.35 kg. No notable differences were found between dose groups. Part B The mean age ranged from 25.7 to 30.3 years in the different dose groups, and the mean body weight from 61.63 to 65.35 kg. No notable differences were found between dose groups. Part C Six women were included in the 4-mg group, with 4 women in the 40-mg group, and 5 women in the placebo group. The mean age ranged from 33.4 to 38.6 years in the different dose groups, which was higher than in healthy subjects in the other study parts. The mean body weight ranged from 59.74 to 61.25kg.

In Part A, subjects were treated with placebo or 4, 16, 40, 80, or 120 mg of DSP-6952 administered orally as a solution (4 mg/ml) (single dose) in fasting conditions and subjects were treated with placebo or 40-mg DSP-6952 administered orally (single dose) after a high-fat meal. In Part B, subjects were treated with placebo or 40, 80, or 120 mg of DSP-6952 administered orally, once daily, after a meal, for 7 days (multiple doses). In Part C, subjects were treated with placebo, or 4 or 40 mg of DSP-6952 administered orally, once daily, after a meal, for 7 days (multiple doses).

No deaths, serious AEs, or withdrawals due to AEs were observed. the most frequent TEAEs were gastrointestinal disorders (diarrhea, abnormal gastrointestinal sounds, and lower abdominal pain). No clinically notable changes or abnormalities were found in clinical laboratory data, vital signs, or 12-lead electrocardiography findings.

DSP-6952 was well tolerated at single and multiple doses up to 120 mg/day

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.

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.

Undecided

Sumitomo Dainippon Pharma Co.,Ltd.

cc@ds-pharma.co.jp

Sumitomo Dainippon Pharma Co.,Ltd.

cc@ds-pharma.co.jp

completed

Aug. 11, 2011

Interventional

(Single-dose administration, Multiple-dose administration) Double-blind, Randomized, Placebo-controlled (Food-effect study part) Double-blind, Randomized, Placebo-controlled

other

1

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.

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

Both

Part A and B
Healthy adult male subjects

Part C
Adult subjects with spontaneous bowel movements 3 times or less a week

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 for Investigational material : Oral administration

control material(s)
Generic name etc : Placebo
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : Oral administration

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

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.

-

Aug. 04, 2011