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A Single and Multiple Oral Dose Study and a Treatment Schedule-finding Study in Non-elderly, Healthy Subjects

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: NCT02500953
Recruitment Status : Completed
First Posted : July 17, 2015
Last Update Posted : July 17, 2015
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Tracking Information
First Submitted Date  ICMJE July 15, 2015
First Posted Date  ICMJE July 17, 2015
Last Update Posted Date July 17, 2015
Study Start Date  ICMJE July 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2015)
  • Safety developed by adverse events, Part 1 [ Time Frame: Up to Day 7 under Fasted and Fed Conditions ]
  • Safety developed by adverse events, Part 2 [ Time Frame: Up to Day 13 ]
  • Safety developed by adverse events, Part 3 [ Time Frame: Up to Day 8 in Period 4 ]
  • Safety developed by Vital signs, Part 1 [ Time Frame: Up to Day 7 ]
  • Safety developed by Vital signs, Part 2 [ Time Frame: Up to Day 13 ]
  • Safety developed by Vital signs, Part 3 [ Time Frame: Up to Day 8 in Period 4 ]
  • Safety developed by Laboratory Tests, Part 1 [ Time Frame: Up to Day 7 under Fasted and Fed Conditions ]
  • Safety developed by Laboratory Tests, Part 2 [ Time Frame: Up to Day 13 ]
  • Safety developed by Laboratory Tests, Part 3 [ Time Frame: Up to Day 8 in Period 4 ]
  • Safety developed by 12-Lead ECG, Part 1 [ Time Frame: Up to Day 7 under Fasted and Fed Conditions ]
    ECG = electrocardiogram
  • Safety developed by 12-Lead ECG, Part 2 [ Time Frame: Up to Day 13 ]
    ECG = electrocardiogram
  • Safety developed by 12-Lead ECG, Part 3 [ Time Frame: Up to Day 8 in Period 4 ]
    ECG = electrocardiogram
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2015)
  • 12-lead continuous ECG for QT assessment [ Time Frame: Up to Day 2 in examination only for administration under fasted condition in Part 1 and Part 2 ]
    ECG: Electrocardiogram
  • Standard 12-lead ECG for QT assessment [ Time Frame: Day -1 ~ 2 in Part 1 and from Day -1 ~1 and Day7~8 in Part 2 ]
    ECG: Electrocardiogram
  • Plasma concentration of ASP3325 [ Time Frame: Day 1, 2, 3 and 4 in Part 1 under Fasted and Fed Conditions, Day 1, 2, 4, 6, 7, 8, 9 and 10 in Part 2, Day 1, 2, 3, 4, 5 in Part 3 ]
  • Urinary concentration of ASP3325 [ Time Frame: Day 1, 2, 3 and 4 in Part 1 under Fasted and Fed Conditions, Day -1, 1, 2, 7, and 8 in Part 2, Day -1, 1, 2, 3, 4, 5 in Part 3 ]
  • Amount of phosphorus excreted in urine and FEP% [ Time Frame: Day 1, 2, 3 and 4 in Part 1 under Fasted Conditions ]
    FEP% = Fractional Phosphate Excretion
  • Amount of phosphorus excreted in urine [ Time Frame: Day -1, 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10 in Part 2 ]
  • Amount of calcium excreted in urine [ Time Frame: Day -1, 1, 2, 7, 8, 9, and 10 in Part 2 ]
  • Amount of phosphorus excreted in feces [ Time Frame: Day -1, 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10 in Part 2 ]
  • Amount of calcium excreted in feces [ Time Frame: Day -1, 1, 2, 7, 8, 9, and 10 in Part 2 ]
  • Amount of FEP% [ Time Frame: Day -1, 1, 2, 7, 8, 9, and 10 in Part 2 ]
    FEP%:Fractional phosphate excretion
  • Amount of phosphorus excreted in urine [ Time Frame: Day -1, 1, 2, 3, and 4 in Part 3 ]
  • Amount of calcium excreted in urine [ Time Frame: Day -1, 1, 2, 3, and 4 in Part 3 ]
  • Amount of phosphorus excreted in feces [ Time Frame: Day -1, 1, 2, 3, and 4 in Part 3 ]
  • Amount of calcium excreted in feces [ Time Frame: Day -1, 1, 2, 3, and 4 in Part 3 ]
  • Amount of FEP% [ Time Frame: Day -1, 1, 2, 3, and 4 in Part 3 ]
    FEP%: Fractional phosphate excretion
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 A Single and Multiple Oral Dose Study and a Treatment Schedule-finding Study in Non-elderly, Healthy Subjects
Official Title  ICMJE A Placebo-controlled, Double-blind, Single and Multiple Oral Dose Study and a Treatment Schedule-finding Study in Non-elderly, Healthy Japanese Male and Female Subjects and Caucasian Male Subjects
Brief Summary The objectives of this study are to evaluate the safety and tolerability of a single and multiple oral dose of ASP3325 and to evaluate the effect of administration timing on the pharmacodynamics of ASP3325 orally administered three times a day.
Detailed Description

<Part 1: Single ascending dose> Primary objective

  • To evaluate the safety and tolerability of a single oral dose of ASP3325 in non-elderly, healthy adult Japanese male and female, and Caucasian male subjects

Secondary objectives

  • To evaluate the pharmacokinetics and pharmacodynamics
  • To evaluate gender differences in the pharmacokinetics and pharmacodynamics
  • To evaluate ethnic differences in the pharmacokinetics and pharmacodynamics between Japanese and Caucasians

<Part 2: Multiple ascending dose> Primary objective

  • To evaluate the safety and tolerability of multiple oral doses of ASP3325 in non-elderly, healthy adult Japanese male and female subjects

Secondary objectives

  • To evaluate the pharmacokinetics and pharmacodynamics
  • To evaluate gender differences in the pharmacokinetics and pharmacodynamics

<Part 3: Evaluation of the effect of administration timing> Primary objective

  • To evaluate the effect of administration timing on the pharmacodynamics of ASP3325 orally administered three times a day at different administration timings of 30 minutes before a meal, during a meal, 30 minutes after a meal, and 2 hours after a meal in non-elderly, healthy adult Japanese male subjects in a crossover design

Secondary objective

  • To evaluate the safety and pharmacokinetics
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Condition  ICMJE Pharmacokinetics of ASP3325 in Non-elderly, Healthy Adult Japanese Male and Female, and Caucasian Male Subjects
Intervention  ICMJE
  • Drug: ASP3325
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Japanese male single fasted ASP dose-1
    ASP3325 will be administered as a single oral dose with 240 mL of water to subjects who have been fasting from 22:00 on the day before administration.
    Intervention: Drug: ASP3325
  • Experimental: Japanese male single fasted ASP dose-2
    ASP3325 will be administered as a single oral dose with 240 mL of water to subjects who have been fasting from 22:00 on the day before administration.
    Intervention: Drug: ASP3325
  • Experimental: Japanese male single fasted ASP dose-3
    ASP3325 will be administered as a single oral dose with 240 mL of water to subjects who have been fasting from 22:00 on the day before administration.
    Intervention: Drug: ASP3325
  • Experimental: Japanese male single fasted ASP dose-4
    ASP3325 will be administered as a single oral dose with 240 mL of water to subjects who have been fasting from 22:00 on the day before administration.
    Intervention: Drug: ASP3325
  • Experimental: Japanese male single fasted ASP dose-5
    ASP3325 will be administered as a single oral dose with 240 mL of water to subjects who have been fasting from 22:00 on the day before administration.
    Intervention: Drug: ASP3325
  • Experimental: Japanese male single fasted ASP dose-6
    ASP3325 will be administered as a single oral dose with 240 mL of water to subjects who have been fasting from 22:00 on the day before administration.
    Intervention: Drug: ASP3325
  • Experimental: Japanese male single fasted ASP dose-7
    ASP3325 will be administered as a single oral dose with 240 mL of water to subjects who have been fasting from 22:00 on the day before administration.
    Intervention: Drug: ASP3325
  • Experimental: Japanese female single fasted ASP dose-3
    ASP3325 will be administered as a single oral dose with 240 mL of water to subjects who have been fasting from 22:00 on the day before administration.
    Intervention: Drug: ASP3325
  • Experimental: Japanese female single fasted ASP dose-5
    ASP3325 will be administered as a single oral dose with 240 mL of water to subjects who have been fasting from 22:00 on the day before administration.
    Intervention: Drug: ASP3325
  • Experimental: Caucasian male single fasted ASP dose-3
    ASP3325 will be administered as a single oral dose with 240 mL of water to subjects who have been fasting from 22:00 on the day before administration.
    Intervention: Drug: ASP3325
  • Experimental: Caucasian male single fasted ASP dose-5
    ASP3325 will be administered as a single oral dose with 240 mL of water to subjects who have been fasting from 22:00 on the day before administration.
    Intervention: Drug: ASP3325
  • Experimental: Japanese male single fed ASP dose-5
    ASP3325 will be administered as a single oral dose with 240 mL of water to subjects after a meal.
    Intervention: Drug: ASP3325
  • Experimental: Japanese male single fasted placebo
    Placebo will be administered as a single oral dose with 240 mL of water to subjects who have been fasting from 22:00 on the day before administration.
    Intervention: Drug: Placebo
  • Experimental: Japanese female single fasted placebo
    Placebo will be administered as a single oral dose with 240 mL of water to subjects who have been fasting from 22:00 on the day before administration.
    Intervention: Drug: Placebo
  • Experimental: Caucasian male single fasted placebo
    Placebo will be administered as a single oral dose with 240 mL of water to subjects who have been fasting from 22:00 on the day before administration.
    Intervention: Drug: Placebo
  • Experimental: Japanese male single fed placebo
    Placebo will be administered as a single oral dose with 240 mL of water to subjects after a meal.
    Intervention: Drug: Placebo
  • Experimental: Japanese male multiple ASP dose-3
    ASP3325 will be administered as multiple oral doses with 240 mL of water, three times a day, just after a meal.
    Intervention: Drug: ASP3325
  • Experimental: Japanese male multiple ASP dose-4
    ASP3325 will be administered as multiple oral doses with 240 mL of water, three times a day, just after a meal.
    Intervention: Drug: ASP3325
  • Experimental: Japanese male multiple ASP dose-5
    ASP3325 will be administered as multiple oral doses with 240 mL of water, three times a day, just after a meal.
    Intervention: Drug: ASP3325
  • Experimental: Japanese female multiple ASP dose-3
    ASP3325 will be administered as multiple oral doses with 240 mL of water, three times a day, just after a meal.
    Intervention: Drug: ASP3325
  • Experimental: Japanese female multiple ASP dose-4
    ASP3325 will be administered as multiple oral doses with 240 mL of water, three times a day, just after a meal.
    Intervention: Drug: ASP3325
  • Experimental: Japanese female multiple ASP dose-5
    ASP3325 will be administered as multiple oral doses with 240 mL of water, three times a day, just after a meal.
    Intervention: Drug: ASP3325
  • Experimental: Japanese male multiple Placebo
    Placebo will be administered with 240 mL of water, three times a day, just after a meal.
    Intervention: Drug: Placebo
  • Experimental: Japanese female multiple Placebo
    Placebo will be administered with 240 mL of water, three times a day, just after a meal.
    Intervention: Drug: Placebo
  • Experimental: Japanese male ASP dose-5 before a meal
    ASP3325 will be administered with 240 mL of water, three times a day, for 2 days.
    Intervention: Drug: ASP3325
  • Experimental: Japanese male ASP dose-5 during a meal
    ASP3325 will be administered with 240 mL of water, three times a day, for 2 days.
    Intervention: Drug: ASP3325
  • Experimental: Japanese male ASP dose-5 after a meal
    ASP3325 will be administered with 240 mL of water, three times a day, for 2 days.
    Intervention: Drug: ASP3325
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: July 15, 2015)
124
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • body weight (at screening)

    • Japanese male: ≥50.0 kg, <80.0 kg
    • Japanese female: ≥40.0 kg, <70.0 kg
    • Caucasian male: ≥50.0 kg, <100.0 kg
  • BMI (at screening)

    • Japanese: ≥17.6 kg/m2, <26.4 kg/m2
    • Caucasians: ≥18.5 kg/m2, <30.0 kg/m2
  • Ethnicity

    • Japanese: (1) The investigator or subinvestigator will confirm the ethnicity based on appearance (skin color: yellow) and the fact that both parents and four grandparents are of the same race (lineage) based on an interview. (2) The subject has not resided outside Japan for 5 years or longer.
    • Caucasians: (1) The investigator or subinvestigator will confirm ethnicity based on appearance (skin color: white or brown) and the fact that both parents and four grandparents are of the same race (lineage) based on an interview. (2) The subject has not resided outside the subject's own country for 5 years or longer.
  • Healthy, as judged by the investigator or subinvestigator based on the results of a medical examination (subjective symptoms and objective findings) and all tests obtained at screening and during the period from hospitalization to immediately before administration.

Exclusion Criteria:

  • Received any investigational drugs in other clinical or post-marketing studies within 120 days before the screening or during the period from the screening to hospitalization (Day −2 [Part 1] or Day −3 [Part 2 and Part 3]) or is scheduled to receive any investigational drugs.
  • Donated more than or equal to 400 mL of whole blood within 90 days before the screening or during the period from the screening to hospitalization (Day −2 [Part 1] or Day −3 [Part 2 and Part 3]), more than or equal to 200 mL of whole blood within 30 days, or blood components within 14 days before the screening, or is scheduled to donate more than or equal to 400 mL of whole blood or blood components.
  • Received medications, vitamins including vitamin D, or supplements including calcium, iron, magnesium, or niacin (nicotinic acid or nicotinamide), or is scheduled to receive medications, within 7 days before hospitalization (Day −2 [Part 1] or Day −3 [Part 2 and Part 3]).
  • A deviation from the normal range of blood pressure, pulse rate, body temperature, or standard 12-lead electrocardiogram (ECG) at screening or Day −1.
  • Any deviation of the following criteria for laboratory tests at screening or Day −1. The normal ranges specified at the study site or the test/assay organization will be used as the normal ranges in this clinical study.

    • Hematology:

      1. A deviation of +20% from the upper limit or −20% lower limit of the normal range. However, if the WBC is within the normal range, each differential count of leukocytes will be ignored.
    • Biochemistry:

      1. A deviation from the normal range for AST, ALT, Cre, blood glucose, and serum electrolytes (Na, K, Cl, Mg, Ca, and P).
      2. A deviation of +20% from the upper limit or −20% lower limit of the normal range for other parameters than the above. However, the lower limit of the normal range will not be established for parameters for which a deviation from the lower limit is not considered clinically significant (AST, ALT, γ-GTP, T-Bil, D-Bil, I-Bil, ALP, LDH, CK, T-Cho, TG, TBA, BUN, Cre, and UA). TBA and iPTH will only be confirmed by laboratory tests at screening.
    • Urinalysis:

      1. A deviation from the normal range of each test parameter (female subjects in Part 2 who are menstruating at screening may be eligible even if urinary blood is positive).
    • Urinary drug abuse test:

      1. A positive result for benzodiazepines, cocaine-based narcotics, analeptic drugs, cannabis, barbituric acid derivatives, morphine-based narcotics, phencyclidines, or tricyclic antidepressants.

    • Immunological test (at screening only):

      1. A positive result for HBs antigen, HBc antibody, HAV antibody (IgM), HCV antibody, HIV antigen/antibody, or syphilis.

    • Pregnancy test:

      1. Female subjects who tested positive for pregnancy.
  • Failure to meet any criteria for 12-lead ECG for QT assessment at screening (Part 1 and Part 2 only).
  • Women who are or may be pregnant, lactating mothers, or women who wish to become pregnant during the study period.
  • Concurrent or history of drug allergies.
  • Upper gastrointestinal disease (e.g. nausea, vomiting, and stomachache) within 7 days before hospitalization (Day −2 [Part 1] or Day −3 [Part 2 and Part 3]).
  • Concurrent or previous hepatic disease (e.g. viral hepatitis and drug-induced liver injury).
  • Concurrent or previous heart disease (e.g. congestive heart failure, ischemic heart disease, and arrhythmia requiring treatment).
  • Concurrent respiratory disease (e.g. bronchial asthma and chronic bronchitis) or previous serious respiratory disease (except for a history of childhood asthma).
  • Concurrent gastrointestinal disease (e.g. peptic ulcer and gastroesophageal reflux esophagitis) or previous serious gastrointestinal disease (except for a history of appendicitis).
  • Previous operation of gut excision (except for a history of appendectomy).
  • Concurrent or previous renal disease (e.g. acute renal failure, glomerulonephritis, and interstitial nephritis; except for a history of calculus).
  • Concurrent or previous endocrine disease (e.g. hyperthyroid, hypothyroid, abnormality of growth hormone).
  • Concurrent or previous cerebrovascular disorder (e.g. cerebral infarction).
  • Concurrent or previous malignant tumor.
  • Excessive drinking or smoking habit. [Measure of "excessive"]:

    • Alcohol: ≥45 g/day [a large bottle of beer contains 25 g of alcohol, and 1 gou of Japanese sake contains 22 g of alcohol]
    • Smoking: ≥20 cigarettes/day
  • Irregular defecation pattern (less frequent than once a day) (Part 2 and Part 3 only).
  • Unable to consume or tolerate phosphorus- and calcium-controlled meals during hospitalization.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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 NCT02500953
Other Study ID Numbers  ICMJE 3325-CL-0001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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 July 2015

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