A Safety and Pharmacokinetics Study of ASP0456 in Healthy Subjects

Astellas

Status and phase: Completed; Phase 1

Conditions: Healthy; Pharmacokinetics of ASP0456

Treatments: Drug: ASP0456; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01279915

0456-CL-0011

Details and patient eligibility

About

A study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending dose of ASP0456 in non-elderly healthy subjects.

Enrollment: 32 patients

Sex: Male

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); ≥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

Trial design

32 participants in 2 patient groups, including a placebo group

ASP group

Experimental group

Description:

ASP0456 receiving group

Treatment:

Drug: ASP0456

Placebo group

Placebo Comparator group

Description:

Placebo treatment

Treatment:

Drug: Placebo