A Study to Evaluate Safety of Multiple Dose of ASP0456 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy; Pharmacokinetics of ASP0456
• Interventions: Drug: Placebo; Drug: ASP0456

• Registration Number: NCT01427387
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

A study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending dose of ASP0456 in non-elderly healthy subjects. Two dosing condition, pre-prandial and postprandial administrations, is compared.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-08-31
• Study First Submitted QC: 2011-08-31
• Status Verified: 2011-09
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Study First Posted: 2011-09-01
• Last Update Submitted: 2011-09-22
• Last Update Posted: 2011-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Healthy, as judged by the investigator/subinvestigator based on the results of physical examination and all tests obtained

• Body weight (at screening);

  • female ≥40.0 kg,<70.0 kg
  • male ≥50.0 kg,<80.0 kg

• BMI(at screening): ≥17.6,<26.4

Exclusion Criteria

• Received any investigational drugs in other clinical or post-marketing studies within 120 days before the study
• Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the study
• Received medication within 10 days before dose is administered or is scheduled to receive medication
• History of drug allergies
• Upper (e.g. nausea, vomiting, stomachache) and lower (e.g. abdominal pain) gastrointestinal disease within 7 days before the study
• Concurrent or previous hepatic disease
• Concurrent or previous heart disease
• Concurrent or previous renal disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part-1 Placebo group	Placebo	Placebo treatment
Part-2 group	ASP0456	cross-over study group to evaluate food effect on ASP0456 plasma concentration
Part-1 ASP group	ASP0456	ASP0456 receiving group

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (such as Cmax, AUC and t1/2 etc.) of ASP0456 assessed by its plasma concentration change	For 48 hours after dosing

Secondary Outcome Measures

Name	Time	Method
Safety assessed by the incidence of adverse events, vital signs, 12-lead ECGs and labo tests	For 48 hours after dosing