DRUG
ASP0456
oral
Status
Completed
Phase
Phase 1
Enrollment
32
Locations
1
Results
Not posted
Publications
0
Study summary
A study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending dose of ASP0456 in non-elderly healthy subjects.
Interventions
DRUG
oral
DRUG
oral
Timeline
First posted
Jan 20, 2011
Study start
Oct 2010
Primary completion
Jan 2011
Study completion
Jan 2011
Results posted
Not reported
Registry updated
Jan 20, 2011
Outcomes
Pharmacokinetics of ASP0456 assessed by its plasma concentration change
Time frame · For 48 hours after dosing
Safety assessed by the incidence of adverse events, vital signs, 12-lead ECGs and labo tests
Time frame · For 48 hours after dosing
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); ≥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 locations
Japan. Showing up to 24 locations stored in the fast local snapshot.
Facility not named
Kantou, Japan
Publications
No PMID-linked publications were present in this registry snapshot.
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