Pharmacokinetic Study of ASP1517 With Kremezin®

NCT02693613 | Completed Phase 1

• 1 other identifier: 1517-CL-0204
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Keywords

Drug-drug interaction; Kremezin; Pharmacokinetics; ASP1517

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• PK parameters of ASP1517: AUClast

  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

  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

  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

  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

  Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing

Study Arms (2)

Group 1

EXPERIMENTAL

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; Drug: Kremezin®

Group 2

EXPERIMENTAL

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; Drug: Kremezin®

Interventions

ASP1517 DRUG

Oral

Group 1; Group 2

Kremezin® DRUG

Oral

Group 1; Group 2

Eligibility Criteria

• Age: 20 Years - 44 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

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 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.

Sponsors & Collaborators

• Astellas Pharma Inc: lead
• Kyntra Bio: collaborator

Study Sites (1)

Site JP00001

Tokyo, Tokyo, Japan

Location

MeSH Terms

Interventions

AST 120

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 3, 2016
• First Posted: February 29, 2016
• Study Start: February 1, 2016
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: June 21, 2016

Record last verified: 2016-05

Locations

JP (1)