Pharmacokinetic Study of ASP1517 With Kremezin®

NCT ID: NCT02693613

Last Updated: 2016-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2016-04-30

Brief Summary

The objective of this study is to evaluate the effect of Kremezin® on the pharmacokinetics of single dose of ASP1517 in healthy non-elderly adult male subjects when administered concomitantly or in a time separated manner.

Conditions

Healthy Volunteers

Study Design

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

Study Groups

Group 1

Treatment arm includes 4 periods, single dose of ASP1517 alone, single dose of ASP1517 + Kremezin® without a time lag, single dose of ASP1517 + Kremezin® with a time lag (1 h before ASP1517 administration) and single dose of ASP1517 + Kremezin® with a time lag (1 h after ASP1517 administration)

Group Type: EXPERIMENTAL

ASP1517

Intervention Type: DRUG

Oral

Kremezin®

Intervention Type: DRUG

Oral

Group 2

Treatment arm includes 3 periods, single dose of ASP1517 alone, single dose of ASP1517 + Kremezin® with a time lag (2 h before ASP1517 administration) and single dose of ASP1517 + Kremezin® with a time lag (2 h after ASP1517 administration)

Group Type: EXPERIMENTAL

ASP1517

Intervention Type: DRUG

Oral

Kremezin®

Intervention Type: DRUG

Oral

Interventions

ASP1517

Oral

Intervention Type: DRUG

Kremezin®

Oral

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Body weight (at screening): ≥50.0 kg and <80.0 kg
• Body-mass index (BMI) (at screening): ≥17.6 and <26.4 kg/m2
• Subject must agree to use contraception consisting of two established forms (1 of which must be a barrier method) starting at the time of informed consent and continuing throughout the treatment period and for 84days after ASP1517 administration in the last period:
• Subject must agree not to donate sperm starting at the time of informed consent and continuing throughout 84 days after the last administration of ASP1517 in the last period.

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 the Period 1 (Day -1).
• Received or is scheduled to receive medications (including over-the-counter [OTC] drugs) within 7 days before the hospital admission day of the Period 1 (Day -1).
• Received or is scheduled to receive supplements within 7 days before the hospital admission day of the Period 1 (Day -1).
• Deviates from any of the normal range of blood pressure, pulse rate, body temperature and standard 12-lead electrocardiogram (ECG) specified at screening or the hospital admission day of the Period 1 (Day -1).
• Meets any of the following criteria for laboratory tests at screening or the hospital admission day of the Period 1 (Day -1). Normal ranges of each test specified at the study site or the test/assay organization will be used as the normal ranges in this study.
• Concurrent or previous drug allergies.
• Development of (an) upper gastrointestinal symptoms within seven days before the hospital admission day of the Period 1 (Day -1).
• Concurrent or previous hepatic disease, heart disease, respiratory disease, gastrointestinal disease, gastrointestinal obstruction,oesophageal varices, renal disease, endocrine disease, cerebrovascular disorder, malignant tumor, retinal neovascular lesions and macular edema.
• Concurrent chronic constipation or diarrhoea.
• 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-0204

Identifier Type: -

Identifier Source: org_study_id