A Food Effect Study to Evaluate the Pharmacokinetics of ASP1517

NCT02805374 | Completed Phase 1

• 1 other identifier: 1517-CL-0202
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Keywords

Pharmacokinetics; ASP1517; Food effect

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• PK parameter of ASP1517 in Plasma: AUClast

  Up to Day 4 of each treatment period

• PK parameter of ASP1517 in Plasma: CL/F

  Up to Day 4 of each treatment period

• PK parameter of ASP1517 in Plasma: λz

  Up to Day 4 of each treatment period

• PK parameter of ASP1517 in Plasma: MRTinf

  Up to Day 4 of each treatment period

• PK parameter of ASP1517 in Plasma: t1/2

  Up to Day 4 of each treatment period

Study Arms (2)

ASP1517 fasting then fed

EXPERIMENTAL

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

ASP1517 fed then fasting

EXPERIMENTAL

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

Interventions

ASP1517 DRUG

Oral

ASP1517 fasting then fed; ASP1517 fed then fasting

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Astellas Pharma Inc: lead
• Kyntra Bio: collaborator

Study Sites (1)

Site JP00001

Tokyo, Tokyo, Japan

Location

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: June 20, 2016
• Study Start: July 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 24, 2016

Record last verified: 2016-08

Locations

JP (1)