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Completed

NCT Number: NCT02952040

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

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.

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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 (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.

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.
  • 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.

Treatment and study plan

ASP1517

Drug

Oral dose

Lanthanum carbonate hydrate

Drug

Oral dose

Other names: Fosrenol

Primary outcomes

  1. Pharmacokinetics (PK) parameter of ASP1517 in plasma: AUCINF

    Time frame: Up to 72hr after each dosing

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

  2. PK parameter of ASP1517 in plasma: AUC24h

    Time frame: Up to 72hr after each dosing

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

  3. PK parameter of ASP1517 in plasma: Cmax

    Time frame: Up to 72hr after each dosing

    Cmax: Maximum concentration

Secondary outcomes

  1. PK parameter of ASP1517 in plasma: AUClast

    Time frame: Up to 72hr after each dosing

    AUC last: 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 72hr after each dosing

    CL/F: Apparent total systemic clearance

  3. PK parameter of ASP1517 in plasma: t1/2

    Time frame: Up to 72hr after each dosing

    t1/2: Terminal elimination half-life

  4. PK parameter of ASP1517 in plasma: Lambda z

    Time frame: Up to 72hr after each dosing

    Lambda z: Terminal elimination rate constant

  5. PK parameter of ASP1517 in plasma: MRTinf

    Time frame: Up to 72hr after each dosing

    MRTinf: Mean residence time from the time of dosing extrapolated to time infinity

  6. PK parameter of ASP1517 in plasma: tmax

    Time frame: Up to 72hr after each dosing

    tmax : Time of Cmax

  7. PK parameter of ASP1517 in plasma: tlag

    Time frame: Up to 72hr after each dosing

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

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

    Time frame: Up to 72hr after each dosing

    Vz/F: Apparent volume of distribution during the terminal elimination phase after single extra-vascular dosing

  9. Safety assessed by incidence of adverse events

    Time frame: Up to 7 days after drug dosing of period 2

  10. Safety assessed by supine blood pressure

    Time frame: Up to 7 days after drug dosing of period 2

  11. Safety assessed by supine pulse rate

    Time frame: Up to 7 days after drug dosing of period 2

  12. Safety assessed by axillary body temperature

    Time frame: Up to 7 days after drug dosing of period 2

  13. Safety assessed by Laboratory tests: Hematology

    Time frame: Up to 7 days after drug dosing of period 2

  14. Safety assessed by Laboratory tests: Blood biochemistry

    Time frame: Up to 7 days after drug dosing of period 2

  15. Safety assessed by Laboratory tests: Urinalysis

    Time frame: Up to 7 days after drug dosing of period 2

  16. Safety assessed by 12-lead electrocardiogram

    Time frame: Up to 7 days after drug dosing of period 2

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 Lanthanum Carbonate Hydrate on the Pharmacokinetics of ASP1517 in Non-elderly Healthy Adult Male Subjects -

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Nov 2, 2016
Registry last updated
Jan 25, 2017

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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