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A Food Effect Study to Evaluate the Pharmacokinetics of ASP1517

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ClinicalTrials.gov Identifier: NCT02805374
Recruitment Status : Completed
First Posted : June 20, 2016
Last Update Posted : August 24, 2016
Sponsor:
Collaborator:
FibroGen
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: ASP1517 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: ASP1517 Pharmacokinetic Study - Evaluation of Food Effect on the Pharmacokinetics of ASP1517
Study Start Date : July 2016
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Arm Intervention/treatment
Experimental: ASP1517 fasting then fed
Subjects will receive a single oral dose of ASP1517 under fasting conditions in period 1, then subjects will receive a single oral dose of ASP1517 under fed conditions in period 2.
Drug: ASP1517
Oral

Experimental: ASP1517 fed then fasting
Subjects will receive a single oral dose of ASP1517 under fed conditions in period 1, then subjects will receive a single oral dose of ASP1517 under fasting conditions in period 2.
Drug: ASP1517
Oral




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   20 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805374


Locations
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Japan
Site JP00001
Tokyo, Japan
Sponsors and Collaborators
Astellas Pharma Inc
FibroGen
Investigators
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Study Director: Medical Director Astellas Pharma Inc
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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT02805374    
Other Study ID Numbers: 1517-CL-0202
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Astellas Pharma Inc:
Pharmacokinetics
ASP1517
Food effect