Pharmacokinetic Study of ASP1517 With Kremezin®

Pharmacokinetic Study of ASP1517 - Evaluation of the Effect of Kremezin® on the Pharmacokinetics of ASP1517 in Non-elderly Healthy Adult Male Subjects, When Administered Concomitantly or in a Time Separated Manner.

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: ASP1517; Drug: Kremezin®

• Study Type: Interventional
• Enrollment (Actual): 34
• 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 (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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Drug: ASP1517; Oral; Drug: Kremezin®; Oral
Experimental: 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)	Drug: ASP1517; Oral; Drug: Kremezin®; Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK) parameter of ASP1517: AUCinf	AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity	Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing
PK parameter of ASP1517: Cmax	Cmax: Maximum concentration	Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK parameters of ASP1517: AUClast	AUClast: Area under the concentration-time curve from the time of dosing extrapolated to the last measurable concentration	Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing
PK parameters of ASP1517: CL/F	CL/F: Apparent total systemic clearance	Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing
PK parameters of ASP1517: t1/2	t1/2: Terminal elimination half-life	Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing
PK parameters of ASP1517: tmax	tmax: Time of Cmax	Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing
PK parameters of ASP1517: tlag	tlag: Time point prior to the time point corresponding to the first measurable (non-zero) concentration	Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing
PK parameters of ASP1517: Vz/F	Vz/F: Apparent volume of distribution during the terminal elimination phase	Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing
Safety assessed by Adverse events		Up to 72 hours after final study drug dosing
Safety assessed by Vital signs	Supine blood pressure, supine pulse rate and axillary body temperature	Up to 72 hours after each study drug dosing
Safety assessed by Laboratory tests	Hematology, blood biochemistry and urinalysis	Up to 72 hours after each study drug dosing
Safety assessed by Standard 12-lead ECG	ECG: Electrocardiogram	Up to 72 hours after each study drug dosing

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc
• Collaborators: FibroGen

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: February 3, 2016
• First Submitted That Met QC Criteria: February 23, 2016
• First Posted (Estimate): February 29, 2016

Study Record Updates

• Last Update Posted (Estimate): June 21, 2016
• Last Update Submitted That Met QC Criteria: June 17, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Drug-drug interaction; ASP1517; Kremezin
• Other Study ID Numbers: 1517-CL-0204

Plan for Individual participant data (IPD)

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