A Drug Interaction Study to Evaluate the Pharmacokinetics of ASP1517 and Lanthanum Carbonate Hydrate

NCT02952040 | Completed Phase 1

• 1 other identifier: 1517-CL-0205
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the effect of lanthanum carbonate hydrate on the pharmacokinetics (PK) of ASP1517 in non-elderly healthy male subjects.

Conditions

Healthy Subjects

Keywords

ASP1517; Pharmacokinetics; Drug-drug interaction

Outcome Measures

Primary Outcomes (3)

• 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 72hr after each dosing

• PK parameter of ASP1517 in plasma: AUC24h

  AUC24h: Area under the concentration-time curve from the time of dosing to 24h

  Up to 72hr after each dosing

• PK parameter of ASP1517 in plasma: Cmax

  Cmax: Maximum concentration

  Up to 72hr after each dosing

Secondary Outcomes (16)

• PK parameter of ASP1517 in plasma: AUClast

  Up to 72hr after each dosing

• PK parameter of ASP1517 in plasma: CL/F

  Up to 72hr after each dosing

• PK parameter of ASP1517 in plasma: t1/2

  Up to 72hr after each dosing

• PK parameter of ASP1517 in plasma: Lambda z

  Up to 72hr after each dosing

• PK parameter of ASP1517 in plasma: MRTinf

  Up to 72hr after each dosing

Study Arms (2)

ASP1517 alone period preceding group

EXPERIMENTAL

Subjects will receive a single oral dose of ASP1517 alone in period 1, then subjects will receive a single oral dose of ASP1517 with lanthanum carbonate hydrate in period 2.

Drug: ASP1517; Drug: Lanthanum carbonate hydrate

ASP1517+lanthanum period preceding group

EXPERIMENTAL

Subjects will receive a single oral dose of ASP1517 with lanthanum carbonate hydrate in period 1, then subjects will receive a single oral dose of ASP1517 alone in period 2.

Drug: ASP1517; Drug: Lanthanum carbonate hydrate

Interventions

ASP1517 DRUG

Oral dose

ASP1517 alone period preceding group; ASP1517+lanthanum period preceding group

Lanthanum carbonate hydrate DRUG

Oral dose

Also known as: Fosrenol

ASP1517 alone period preceding group; ASP1517+lanthanum period preceding group

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 (at screening): ≥17.6 and \<26.4 kg/m2 \[Body-mass index = Body weight (kg)/(Height (m))2\]
• Subject must agree to use contraception consisting of two established forms specified below starting at the time of informed consent and continuing throughout the treatment period and for 84 days after the last administration of ASP1517.
• 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.

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.
• Received or is scheduled to receive medications (including over-the-counter drugs) or 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 at screening or the hospital admission day of the Period 1.
• Meets any of the following criteria for laboratory tests at screening or the hospital admission day of the Period 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 symptom(s) within 7 days before the hospital admission day of the Period 1.
• Concurrent or previous hepatic disease, heart disease, respiratory disease, peritoneum inflammation.
• A history of abdominal surgery, digestive tract excision.
• Concurrent or previous renal disease, endocrine disease, cerebrovascular disorder, malignant tumor, retinal neovascular lesions.
• Previous use of hypoxia inducible factor-prolyl hydroxylase inhibitors (HIF-PHI) such as ASP1517 (FG-4592), YM311 (FG-2216), erythropoietin products or lanthanum carbonate hydrate.
• 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

lanthanum carbonate

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: October 31, 2016
• First Posted: November 2, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 25, 2017

Record last verified: 2017-01

Locations

JP (1)