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

Astellas

Status and phase

Completed

Phase 1

Conditions

Healthy

Pharmacokinetics of ASP0456

Treatments

Drug: Placebo

Drug: ASP0456

Study type

Interventional

Funder types

Industry

Identifiers

NCT01427387

0456-CL-0012

Details and patient eligibility

About

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.

Enrollment

44 patients

Sex

All

Ages

20 to 44 years old

Volunteers

Accepts Healthy Volunteers

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