Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bioequivalence Evaluation of a New and Current Tablet of ASP015K

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02531191
Recruitment Status : Completed
First Posted : August 24, 2015
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Tracking Information
First Submitted Date  ICMJE July 30, 2015
First Posted Date  ICMJE August 24, 2015
Last Update Posted Date September 16, 2019
Actual Study Start Date  ICMJE June 21, 2015
Actual Primary Completion Date July 15, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2015)
  • Pharmacokinetics (PK) parameter of ASP015K: Area under the concentration-time curve (AUC) from the time of dosing to the time of the last sampling (AUCt) [ Time Frame: Up to 72 hours after each study drug dosing ]
  • Pharmacokinetics (PK) parameter of ASP015K: Maximum concentration (Cmax) [ Time Frame: Up to 72 hours after each study drug dosing ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02531191 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2015)
  • Safety assessed by Adverse Events (AEs) [ Time Frame: Up to 6 days after the study drug dosing of Period 2 ]
  • Safety assessed by Vital signs [ Time Frame: Up to 6 days after the study drug dosing of Period 2 ]
    Vital signs include systolic and diastolic blood pressures, pulse rate and temperature.
  • Safety assessed by Laboratory tests [ Time Frame: Up to 6 days after the study drug dosing of Period 2 ]
    Laboratory tests include hematology, biochemistry, urinalysis.
  • Safety assessed by 12-lead ECGs [ Time Frame: Up to 6 days after the study drug dosing of Period 2 ]
    12-lead ECG: 12-lead electrocardiogram
  • Pharmacokinetics (PK) profile of ASP015K: AUCinf [ Time Frame: Up to 72 hours after each study drug dosing ]
    AUCinf: AUC from the time of dosing extrapolated to time infinity
  • Pharmacokinetics (PK) profile of ASP015K: AUClast [ Time Frame: Up to 72 hours after each study drug dosing ]
    AUClast: AUC from the time of dosing to the last measurable concentration
  • Pharmacokinetics (PK) profile of ASP015K: CL/F [ Time Frame: Up to 72 hours after each study drug dosing ]
    CL/F: Apparent total systemic clearance
  • Pharmacokinetics (PK) profile of ASP015K: kel [ Time Frame: Up to 72 hours after each study drug dosing ]
    kel: Terminal elimination rate constant
  • Pharmacokinetics (PK) profile of ASP015K: MRTinf [ Time Frame: Up to 72 hours after each study drug dosing ]
    MRTinf: Mean residence time from the time of dosing extrapolated to time infinity
  • Pharmacokinetics (PK) profile of ASP015K: t1/2 [ Time Frame: Up to 72 hours after each study drug dosing ]
    t1/2: Terminal elimination half-life
  • Pharmacokinetics (PK) profile of ASP015K: tmax [ Time Frame: Up to 72 hours after each study drug dosing ]
    tmax: Time of Cmax (Maximum concentration)
  • Pharmacokinetics (PK) profile of ASP015K: Vz/F [ Time Frame: Up to 72 hours after each study drug dosing ]
    Apparent volume of distribution during the terminal elimination phase
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioequivalence Evaluation of a New and Current Tablet of ASP015K
Official Title  ICMJE ASP015K Pharmacokinetic Study - Bioequivalence Evaluation of a Small and Current Tablet of ASP015K
Brief Summary The objective of this study is to evaluate the bioequivalence of a new tablet versus a current tablet of ASP015K under fasting conditions after single oral administration in healthy male subjects.
Detailed Description This is an open-label, randomized, single dose, 2-way crossover designed study. Forty non-elderly healthy male subjects will receive an ASP015K small tablet or an ASP015K current tablet in each period under fasted conditions. If the bioequivalence between two tablets cannot be demonstrated because of an insufficient number, an add-on subject study will be conducted as needed. The design of the add-on subject study will be the same with that of the initial study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE Drug: peficitinib
oral
Other Name: ASP015K
Study Arms  ICMJE
  • Experimental: New Tablet Preceding Group
    Each subject received an ASP015K small tablet in period 1 and an ASP015K current tablet in period 2 under fasted conditions with 200 mL of water.
    Intervention: Drug: peficitinib
  • Experimental: Current Tablet Preceding Group
    Each subject received an ASP015K current tablet in period 1 and an ASP015K small tablet in period 2 under fasted conditions with 200 mL of water.
    Intervention: Drug: peficitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 20, 2015)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 15, 2015
Actual Primary Completion Date July 15, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 50.0 kg ≤ body weight at screening < 80.0 kg
  • 17.6 ≤ BMI at screening < 26.4 [BMI = Body weight (kg) / (Body height (m))2]
  • Subjects who agree to use the following highly effective contraception consisting of two forms of birth control (at least one of which must be a barrier method) starting at written informed consent through 90 days after the study drug administration in Period 2.
  • Subjects who agree not to donate sperm starting at informed consent through 90 days after the study drug administration in Period 2.
  • Subjects judged as healthy by investigator or sub-investigator based on physical examinations (subjective symptoms and objective findings) and all clinical tests obtained at screening and from check-in to immediately before the study drug administration in Period 1.

Exclusion Criteria:

  • Subjects who have received investigational drugs within 120 days prior to screening or who plan to receive investigational drugs from screening assessment to check-in in Period 1 (Day -1).
  • Any blood donation or blood drawing apply the following:

    • Whole blood collection (≥ 400 mL): from 90 days prior to screening to check-in in Period 1 (Day -1)
    • Whole blood collection (≥ 200 mL): from 30 days prior to screening to check-in in Period 1 (Day -1)
    • Platelet or plasma donation: from 30 days prior to screening to check-in in Period 1 (Day -1)
  • Subjects who had used or plan to use any prescribed or non-prescribed drugs within 7 days prior to check-in in Period 1 (Day -1).
  • Any deviation of blood pressure, pulse, body temperature, or 12-lead ECG at screening or check-in in Period 1 (Day -1) from the following normal range:

    • Supine pressure: Systolic: ≥ 90 mmHg, ≤ 140 mmHg; Diastolic: ≥ 40 mmHg, ≤ 90 mmHg
    • Supine pulse: ≥ 40 bpm, ≤ 99 bpm
    • Axillary temperature: ≥ 35.0 ºC, ≤ 37.0 ºC
    • 12-lead ECG: Normal or clinically irrelevant abnormality QTc interval: ≥ 330 msec, < 430 msec
  • Any deviation of laboratory tests at Screening or on Day -1 (check-in) in Period 1 from the following normal range. Normal range of each test at the test or assay site will be used.

    • Hematology: > 20% of upper limit or < 20% of lower limit.
    • Chemistry: deviation of ALT, AST, Cre, blood electrolytes (Na, K, Cl), or fasting blood glucose. > 20% of upper limit or < 20% of lower limit in other than above tests; however no lower limit is set with respect to ALT, AST, γ-GTP, T-Bil, ALP, LDH, CK, T-Cho, TG, Cre, and UA.
    • Urinalysis (qualitative): deviation in any of the urinalysis.
    • Urinary drug abuse test: positive for benzodiazepines, cocaine-based narcotics, analeptic drugs, cannabis, barbituric acid derivatives, morphine-based narcotics, phencyclidines, or tricyclic antidepressants.
    • Immunological test: positive for HBs antigen, HBc antibody, HCV antibody, HIV antigen or antibody, or syphilis.
  • Subjects who have any history or complication of drug allergies.
  • Subjects who have a history of upper gastrointestinal symptoms, i.e. nausea, vomit, stomach ache, etc. within 7 days prior to check-in in Period 1 (Day -1).
  • Subjects who have any history or complication of hepatic disease, i.e. viral hepatitis, drug induced liver injury, hepatic dysfunction, etc.
  • Subjects who have any history or complication of cardiac disease, i.e. congestive heart failure, angina, arrhythmia requires a treatment, etc.
  • Subjects who have any history or complication of respiratory disease, i.e. bronchial asthma, chronic bronchitis, pneumonitis, etc. (except for a history of asthma in childhood)
  • Subjects who have any history or complication of gastrointestinal disease, i.e. peptic ulcer, reflux esophagitis, etc. (except for a history of appendicitis)
  • Subjects who have any history of gastrointestinal resection (except for a history of appendectomy)
  • Subjects who have any history or complication of renal disease, i.e. acute renal failure, glomerulonephritis, intestinal nephritis, etc.
  • Subjects who have any history or complication of endocrine disease, i.e. hyperthyroidism, abnormality of growth hormone, etc.
  • Subjects who have any history or complication of cerebrovascular disorder, i.e. cerebral infarction.
  • Subjects who have any history or complication of malignant tumor.
  • Subjects who have any history or complication of congenital short QT syndrome.
  • Subjects who have any history or complication of lymphatic disease, i.e. lymphoproliferative disease.
  • Subjects any of the following apply regarding tuberculosis:

    • History of active tuberculosis
    • Abnormality in chest X-ray test at screening
    • Contact with patients with infectious tuberculosis
  • Subjects any of the following apply regarding infectious disease other than tuberculosis:

    • History or complication of serious herpes zoster or disseminated herpes zoster
    • More than once relapse of localized herpes zoster
    • Hospitalization due to serious infection within 90 days before check-in in Period 1 (Day -1)
    • I.V. antibiotics treatment within 90 days before check-in in Period 1 (Day -1) (except for prevention use)
    • Judged as prone to infections by investigator or sub-investigator, i.e. subjects with urethral catheterization.
  • Subjects who have any history of inoculation of live vaccine or attenuated live vaccine within 56 days prior to check-in in Period 1 (Day -1).
  • Subjects who have any history of clinically serious allergy (Clinically serious allergy; allergy induced systemic urticaria or anaphylactic shock require hospitalization when exposed to specific antigens or drugs).
  • Subjects who have any history or complication of heart failure classified as NYHA Class III or IV.
  • Subjects who have a history of ASP015K administration.
  • Subjects with excessive alcohol drinking or smoking.

    • Criteria for "excessive":

      1. Smoking: ≥ 20 cigarettes/day
      2. Alcohol drinking: ≥ 45 g/day (a large bottle of beer contains 25 g of alcohol, 1 gou of Japanese sake contains 22 g of alcohol)
  • Employee of the sponsor, CROs or study site involved in this study.
  • Subjects judged as inappropriate for the study by investigator or sub-investigators.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 44 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02531191
Other Study ID Numbers  ICMJE 015K-CL-PK27
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
Responsible Party Astellas Pharma Inc
Study Sponsor  ICMJE Astellas Pharma Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Astellas Pharma Inc
PRS Account Astellas Pharma Inc
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP