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

NCT00978198 | Completed Phase 1

• 1 other identifier: 1517-CL-0201
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

Pharmacokinetics; Safety and tolerability; Plasma concentration; ASP1517; FG-4592

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of ASP1517

  During 2 weeks

Secondary Outcomes (1)

• Pharmacokinetics of ASP1517

  During 2 weeks

Study Arms (2)

Part 1

EXPERIMENTAL

single administration

Drug: ASP1517; Drug: Placebo

Part 2

EXPERIMENTAL

multiple administration

Drug: ASP1517; Drug: Placebo

Interventions

ASP1517 DRUG

oral

Also known as: FG-4592

Part 1; Part 2

Placebo DRUG

oral

Part 1; Part 2

Eligibility Criteria

• Age: 20 Years - 44 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Unknown Facility

Kantou, Japan

Location

MeSH Terms

Interventions

roxadustat

Study Officials

• Use Central Contact

  Astellas Pharma Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 15, 2009
• First Posted: September 16, 2009
• Study Start: September 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: June 22, 2010

Record last verified: 2010-06

Locations

JP (1)