Safety, Tolerability and Pharmacokinetic Study of ASP1517 in Healthy Non-elderly Male Volunteers

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00978198
First received: September 15, 2009
Last updated: June 16, 2010
Last verified: June 2010
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00978198

Locations
Japan
Kantou, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc
  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 April 22, 2014