Safety, Tolerability and Pharmacokinetic Study of ASP1517 in Healthy Non-elderly Male Volunteers
This study has been completed.
Sponsor:
Astellas Pharma Inc
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00978198
First received: September 15, 2009
Last updated: June 16, 2010
Last verified: June 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Volunteers |
Drug: ASP1517 Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) |
| Official Title: | ASP1517 Phase 1 Clinical Study - Single and Multiple Oral Dosing of ASP1517 in Healthy Non-elderly Male Volunteers |
Further study details as provided by Astellas Pharma Inc:
Primary Outcome Measures:
- Safety and tolerability of ASP1517 [ Time Frame: During 2 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pharmacokinetics of ASP1517 [ Time Frame: During 2 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 100 |
| Study Start Date: | September 2009 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Part 1
single administration
|
Drug: ASP1517
oral
Other Name: FG-4592
Drug: Placebo
oral
|
|
Experimental: Part 2
multiple administration
|
Drug: ASP1517
oral
Other Name: FG-4592
Drug: Placebo
oral
|
Detailed Description:
The study consists of two parts, single and multiple dose. Within each part participants will be randomized to either ASP1517 or placebo.
Eligibility| Ages Eligible for Study: | 20 Years to 44 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
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)
Contacts and Locations More Information
No publications provided
| Responsible Party: | Director, Astellas Pharma , Inc |
| ClinicalTrials.gov Identifier: | NCT00978198 History of Changes |
| Other Study ID Numbers: | 1517-CL-0201 |
| Study First Received: | September 15, 2009 |
| Last Updated: | June 16, 2010 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Keywords provided by Astellas Pharma Inc:
|
Pharmacokinetics Safety and tolerability Plasma concentration ASP1517 FG-4592 |
ClinicalTrials.gov processed this record on May 16, 2013