Kantou, Japan
NCT Number: NCT00978198
Safety, Tolerability and Pharmacokinetic Study of ASP1517 in Healthy Non-elderly Male Volunteers
The purpose of the study is to evaluate the safety and tolerability of ASP1517 after single or multiple oral administration in healthy non-elderly adult male subjects.
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Notify MeKey information
Conditions
Age range
20 year–44 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Primary location
About this study
The study consists of two parts, single and multiple dose. Within each part participants will be randomized to either ASP1517 or placebo.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Body weight: ≥50.0 kg, <80.0 kg
- BMI: ≥18.5 kg/m2, <25.0 kg/m2
- Eligible, as judged by the investigator/subinvestigator based on the results of physical examinations (subjective symptoms and objective findings) and all tests obtained at screening and up to the timing immediately before study medication
- Supine blood pressure: Systolic blood pressure ≥90 mmHg, ≤130 mmHg; Diastolic blood pressure ≤85 mmHg
- Pulse rate at rest in supine position: ≥40 bpm, <100 bpm
Exclusion criteria
- Received any investigational drugs in other clinical or post-marketing studies within 120 days before the screening assessment
- 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 screening assessment
- Received medication within 7 days before hospital admission or is scheduled to receive medication
- History of drug allergies
- Upper gastrointestinal disease (e.g. nausea, vomiting, stomachache) within 7 days before the study
- Excessive smoking or drinking habit (measure of "excessive": alcohol: 45 g/day, smoking: 20 cigarettes/day)
Treatment and study plan
ASP1517
Drugoral
Other names: FG-4592
Placebo
Drugoral
Primary outcomes
-
Safety and tolerability of ASP1517
Time frame: During 2 weeks
Secondary outcomes
-
Pharmacokinetics of ASP1517
Time frame: During 2 weeks
Sponsors and collaborators
Lead sponsor
Astellas Pharma Inc
Industry
Registry information
Official study title
ASP1517 Phase 1 Clinical Study - Single and Multiple Oral Dosing of ASP1517 in Healthy Non-elderly Male Volunteers
Important dates
- Study start
- 2009
- Primary completion
- 2010
- Study completion
- 2010
- First posted
- Sep 16, 2009
- Registry last updated
- Jun 22, 2010
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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