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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 29, 2014