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Completed

NCT Number: NCT02805374

A Food Effect Study to Evaluate the Pharmacokinetics of ASP1517

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.

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Key information

Conditions

Age range

20 year–44 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Site JP00001

Tokyo, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ASP1517

Drug

Oral

Primary outcomes

  1. Pharmacokinetics (PK) parameter of ASP1517 in Plasma: AUCinf

    Time frame: Up to Day 4 of each treatment period

    AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity

  2. PK parameter of ASP1517 in Plasma: Cmax

    Time frame: Up to Day 4 of each treatment period

    Cmax: Maximum concentration

Secondary outcomes

  1. PK parameter of ASP1517 in Plasma: AUClast

    Time frame: Up to Day 4 of each treatment period

    AUClast: Area under the concentration-time curve from the time of dosing to the last measurable concentration

  2. PK parameter of ASP1517 in Plasma: CL/F

    Time frame: Up to Day 4 of each treatment period

    CL/F: Apparent total systemic clearance

  3. PK parameter of ASP1517 in Plasma: λz

    Time frame: Up to Day 4 of each treatment period

    λz: Terminal rate constant

  4. PK parameter of ASP1517 in Plasma: MRTinf

    Time frame: Up to Day 4 of each treatment period

    MRTinf: Mean residence time extrapolated to infinity

  5. PK parameter of ASP1517 in Plasma: t1/2

    Time frame: Up to Day 4 of each treatment period

    t1/2: Terminal elimination half-life

  6. PK parameter of ASP1517 in Plasma: tmax

    Time frame: Up to Day 4 of each treatment period

    tmax: Time of Cmax

  7. PK parameter of ASP1517 in Plasma: tlag

    Time frame: Up to Day 4 of each treatment period

    tlag: Lag time

  8. PK parameter of ASP1517 in Plasma: Vz/F

    Time frame: Up to Day 4 of each treatment period

    Vz/F: Apparent volume of distribution during the terminal elimination phase

  9. PK parameter of ASP1517 in Urine: Ae

    Time frame: Up to Day 4 of each treatment period

    Ae: Cumulative amount of ASP1517 excreted into urine

  10. PK parameter of ASP1517 in Urine: CLR

    Time frame: Up to Day 4 of each treatment period

    CLR: Renal clearance

  11. Safety assessed by adverse events

    Time frame: Up to Day 9 of Period 2

  12. Number of participants with abnormal vital signs and/or adverse events during treatment period

    Time frame: Up to Day 9 of Period 2

  13. Number of participants with abnormal laboratory values and/or adverse events during treatment period

    Time frame: Up to Day 9 of Period 2

  14. Number of participants with abnormal standard 12-Lead ECG and/or adverse events during treatment period

    Time frame: Up to Day 9 of Period 2

    ECG: Electrocardiogram

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Collaborators

  • Kyntra Bio

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 20, 2016
Registry last updated
Aug 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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