A Food Effect Study to Evaluate the Pharmacokinetics of ASP1517

NCT ID: NCT02805374

Last Updated: 2016-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2016-08-31

Brief Summary

The objective of this study is to evaluate the effect of food on the pharmacokinetics of a single oral dose of ASP1517 in non-elderly healthy adult male subjects.

Conditions

Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

ASP1517 fasting then fed

Subjects will receive a single oral dose of ASP1517 under fasting conditions in period 1, then subjects will receive a single oral dose of ASP1517 under fed conditions in period 2.

Group Type: EXPERIMENTAL

ASP1517

Intervention Type: DRUG

Oral

ASP1517 fed then fasting

Subjects will receive a single oral dose of ASP1517 under fed conditions in period 1, then subjects will receive a single oral dose of ASP1517 under fasting conditions in period 2.

Group Type: EXPERIMENTAL

ASP1517

Intervention Type: DRUG

Oral

Interventions

ASP1517

Oral

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Body weight: ≥50.0 kg and <80.0 kg
• Body-mass index : ≥17.6 and <26.4 kg/m2
• Subject must agree to use two of the established contraceptive methods after informed consent acquisition through 84 days after the last administration of the study drug.
• Subject must agree not to donate sperm after informed consent acquisition through 84 days after the last administration of the study drug.

Exclusion Criteria

• Received or is scheduled to receive any investigational drugs in other clinical trials or post-marketing studies within 120 days before screening or during the period from screening to the hospital admission day of Period 1
• Received or is scheduled to receive medications (including over-the-counter [OTC] drugs) within 7 days before the hospital admission day of Period 1
• Received or is scheduled to receive supplements within 7 days before the hospital admission day of the Period 1
• Deviates from any of the normal range of blood pressure, pulse rate, body temperature and standard 12-lead electrocardiogram (ECG) at screening or the hospital admission day of Period 1
• Meets any of the criteria for laboratory tests at screening or the hospital admission day of Period 1. Normal ranges of each test specified at the test/assay organization will be used as the normal ranges in this study.
• Concurrent or previous drug allergies.
• Development of (an) upper gastrointestinal symptom(s) within seven days before the hospital admission day of Period 1.
• Concurrent or previous hepatic disease, heart disease, respiratory disease, gastrointestinal disease, renal disease, endocrine disease, cerebrovascular disorder, malignant tumor, retinal neovascular lesions and macular edema.
• A history of digestive tract excision.
• Previous use of hypoxia inducible factor-prolyl hydroxylase inhibitors (HIF-PHI) such as ASP1517 (FG-4592), YM311(FG-2216) or erythropoietin products.
• Excessive alcohol or smoking habit.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

FibroGen

INDUSTRY

Sponsor Role: collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Inc

Locations

Site JP00001

Tokyo, Tokyo, Japan

Countries

Japan

Other Identifiers

1517-CL-0202

Identifier Type: -

Identifier Source: org_study_id