CClinicalTrials.gg
CompletedNCT00978198Updated Jun 22, 2010

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

A Phase 1 interventional study of ASP1517 and Placebo in Healthy Volunteers, sponsored by Astellas Pharma Inc. Completed at 1 site in Japan. Open to male participants aged 20 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-06-22.

Sponsored by Astellas Pharma Inc · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
20 Years to 44 Years
Sex
Male
01

Study summary

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.

Read the detailed description

The study consists of two parts, single and multiple dose. Within each part participants will be randomized to either ASP1517 or placebo.

02

Conditions studied

  • Healthy Volunteers

Keywords

  • Pharmacokinetics
  • Safety and tolerability
  • Plasma concentration
  • ASP1517
  • FG-4592
03

In context

Lead sponsor

Astellas Pharma Inc is the lead sponsor of 512 studies on the registry; 4 are open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 44 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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)
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Part 1

    single administration

    Drug: ASP1517 · Drug: Placebo

  • Experimental
    Part 2

    multiple administration

    Drug: ASP1517 · Drug: Placebo

Interventions

  • DrugASP1517

    oral

    Also known as: FG-4592

  • DrugPlacebo

    oral

06

What researchers measure

Primary outcomes

  1. Safety and tolerability of ASP1517

    Time frame: During 2 weeks

Secondary outcomes

  1. Pharmacokinetics of ASP1517

    Time frame: During 2 weeks

07

Study locations

1 site
  • Kantou, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00978198
Lead sponsor
Astellas Pharma Inc
First posted
Sep 16, 2009
Start date
Sep 2009
Primary completion
Jun 2010
Completion
Jun 2010
Last update
Jun 22, 2010

Study contacts

Use Central Contact
study chair · Astellas Pharma Inc

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion