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Completed

NCT Number: NCT02693613

Pharmacokinetic Study of ASP1517 With Kremezin®

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.

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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 (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.

Treatment and study plan

ASP1517

Drug

Oral

Kremezin®

Drug

Oral

Primary outcomes

  1. Pharmacokinetics (PK) parameter of ASP1517: AUCinf

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

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

  2. PK parameter of ASP1517: Cmax

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

    Cmax: Maximum concentration

Secondary outcomes

  1. PK parameters of ASP1517: AUClast

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

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

  2. PK parameters of ASP1517: CL/F

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

    CL/F: Apparent total systemic clearance

  3. PK parameters of ASP1517: t1/2

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

    t1/2: Terminal elimination half-life

  4. PK parameters of ASP1517: tmax

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

    tmax: Time of Cmax

  5. PK parameters of ASP1517: tlag

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

    tlag: Time point prior to the time point corresponding to the first measurable (non-zero) concentration

  6. PK parameters of ASP1517: Vz/F

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

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

  7. Safety assessed by Adverse events

    Time frame: Up to 72 hours after final study drug dosing

  8. Safety assessed by Vital signs

    Time frame: Up to 72 hours after each study drug dosing

    Supine blood pressure, supine pulse rate and axillary body temperature

  9. Safety assessed by Laboratory tests

    Time frame: Up to 72 hours after each study drug dosing

    Hematology, blood biochemistry and urinalysis

  10. Safety assessed by Standard 12-lead ECG

    Time frame: Up to 72 hours after each study drug dosing

    ECG: Electrocardiogram

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Collaborators

  • Kyntra Bio

Registry information

Official study title

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.

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 29, 2016
Registry last updated
Jun 21, 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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