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

Healthy Clinical Trial

Official title:

Phase I Study of ASP0456 - A Double-blind, Placebo-controlled, Multiple Ascending Dose Study / Investigational Study for Dose Timing Selection in Non Elderly Healthy Subjects-

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01427387
• Other study ID #: 0456-CL-0012
• Status: Completed
• Phase: Phase 1
• First received: August 31, 2011
• Last updated: September 22, 2011
• Start date: June 2011
• Est. completion date: September 2011

Study information

• Verified date: September 2011
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 44 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Healthy
• Pharmacokinetics of ASP0456

Intervention

Drug:
• ASP0456
oral
• Placebo
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (such as Cmax, AUC and t1/2 etc.) of ASP0456 assessed by its plasma concentration change		For 48 hours after dosing	No
Secondary	Safety assessed by the incidence of adverse events, vital signs, 12-lead ECGs and labo tests		For 48 hours after dosing	No