A Food Effect Study to Evaluate the Pharmacokinetics of ASP1517

ASP1517 Pharmacokinetic Study - Evaluation of Food Effect on the Pharmacokinetics of ASP1517

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: ASP1517

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Site JP00001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 44 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: ASP1517; Oral
EXPERIMENTAL: 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.	Drug: ASP1517; Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK) parameter of ASP1517 in Plasma: AUCinf	AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity	Up to Day 4 of each treatment period
PK parameter of ASP1517 in Plasma: Cmax	Cmax: Maximum concentration	Up to Day 4 of each treatment period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK parameter of ASP1517 in Plasma: AUClast	AUClast: Area under the concentration-time curve from the time of dosing to the last measurable concentration	Up to Day 4 of each treatment period
PK parameter of ASP1517 in Plasma: CL/F	CL/F: Apparent total systemic clearance	Up to Day 4 of each treatment period
PK parameter of ASP1517 in Plasma: λz	λz: Terminal rate constant	Up to Day 4 of each treatment period
PK parameter of ASP1517 in Plasma: MRTinf	MRTinf: Mean residence time extrapolated to infinity	Up to Day 4 of each treatment period
PK parameter of ASP1517 in Plasma: t1/2	t1/2: Terminal elimination half-life	Up to Day 4 of each treatment period
PK parameter of ASP1517 in Plasma: tmax	tmax: Time of Cmax	Up to Day 4 of each treatment period
PK parameter of ASP1517 in Plasma: tlag	tlag: Lag time	Up to Day 4 of each treatment period
PK parameter of ASP1517 in Plasma: Vz/F	Vz/F: Apparent volume of distribution during the terminal elimination phase	Up to Day 4 of each treatment period
PK parameter of ASP1517 in Urine: Ae	Ae: Cumulative amount of ASP1517 excreted into urine	Up to Day 4 of each treatment period
PK parameter of ASP1517 in Urine: CLR	CLR: Renal clearance	Up to Day 4 of each treatment period
Safety assessed by adverse events		Up to Day 9 of Period 2
Number of participants with abnormal vital signs and/or adverse events during treatment period		Up to Day 9 of Period 2
Number of participants with abnormal laboratory values and/or adverse events during treatment period		Up to Day 9 of Period 2
Number of participants with abnormal standard 12-Lead ECG and/or adverse events during treatment period	ECG: Electrocardiogram	Up to Day 9 of Period 2

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc
• Collaborators: FibroGen

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (ACTUAL): August 1, 2016
• Study Completion (ACTUAL): August 1, 2016

Study Registration Dates

• First Submitted: June 16, 2016
• First Submitted That Met QC Criteria: June 16, 2016
• First Posted (ESTIMATE): June 20, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): August 24, 2016
• Last Update Submitted That Met QC Criteria: August 22, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Food effect; ASP1517
• Other Study ID Numbers: 1517-CL-0202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED