Overview

A Safety and Pharmacokinetics Study of ASP0456 in Healthy Subjects

Status:
Completed
Trial end date:
2011-01-01
Target enrollment:
0
Participant gender:
Male
Summary
A study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending dose of ASP0456 in non-elderly healthy subjects.
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); ≥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