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

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Linaclotide

Criteria

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