A Food Effect Study to Evaluate the Pharmacokinetics of ASP1517

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02805374
• Other study ID #: 1517-CL-0202
• Status: Completed
• Phase: Phase 1
• First received: June 16, 2016
• Last updated: August 22, 2016
• Start date: July 2016
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 44 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• ASP1517
Oral

Locations

Country	Name	City	State
Japan	Site JP00001	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	FibroGen

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	PK parameter of ASP1517 in Plasma: Cmax	Cmax: Maximum concentration	Up to Day 4 of each treatment period	No
Secondary	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	No
Secondary	PK parameter of ASP1517 in Plasma: CL/F	CL/F: Apparent total systemic clearance	Up to Day 4 of each treatment period	No
Secondary	PK parameter of ASP1517 in Plasma: ?z	?z: Terminal rate constant	Up to Day 4 of each treatment period	No
Secondary	PK parameter of ASP1517 in Plasma: MRTinf	MRTinf: Mean residence time extrapolated to infinity	Up to Day 4 of each treatment period	No
Secondary	PK parameter of ASP1517 in Plasma: t1/2	t1/2: Terminal elimination half-life	Up to Day 4 of each treatment period	No
Secondary	PK parameter of ASP1517 in Plasma: tmax	tmax: Time of Cmax	Up to Day 4 of each treatment period	No
Secondary	PK parameter of ASP1517 in Plasma: tlag	tlag: Lag time	Up to Day 4 of each treatment period	No
Secondary	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	No
Secondary	PK parameter of ASP1517 in Urine: Ae	Ae: Cumulative amount of ASP1517 excreted into urine	Up to Day 4 of each treatment period	No
Secondary	PK parameter of ASP1517 in Urine: CLR	CLR: Renal clearance	Up to Day 4 of each treatment period	No
Secondary	Safety assessed by adverse events		Up to Day 9 of Period 2	No
Secondary	Number of participants with abnormal vital signs and/or adverse events during treatment period		Up to Day 9 of Period 2	No
Secondary	Number of participants with abnormal laboratory values and/or adverse events during treatment period		Up to Day 9 of Period 2	No
Secondary	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	No