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Pharmacokinetics and Tolerability of Minodronic Acid and Food and Age Effects on the Pharmacokinetics

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
minodronic acid
Sponsored by
Wuhan Union Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Osteoporosis focused on measuring minodronic acid, pharmacokinetics, tolerability, food, age, Chinese subjects

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subjects were included based on the following criteria:

    • males or females aged 19 to 35 years for young subjects or aged 60 to 65 years for elderly subjects
    • body mass index between 19 and 24 kg/m2
    • thorax radiography and ECG with no abnormalities
    • normal blood pressure values
    • heart rate
    • laboratory test results (hematology, blood biochemistry, hepatic function, and urinalysis)
    • negative test results for HIV and hepatitis B.

Exclusion Criteria:

  • Subjects were excluded if they had a heart disease or disorder
  • A hepatic, renal, respiratory, immune system, or nervous system disorder

  • Any of the following conditions:

    • pregnancy
    • breast-feeding
    • hypocalcemia
    • prescription or over-the-counter medication use (including herbal products) within 2 weeks before the initiation of the study
    • blood donation or participation in other clinical trials within 3 months before enrollment in the study
    • alcohol or drug abuse
    • smoking more than 10 a day
    • clinically significant allergies to drugs or foods
    • sitting blood pressure <80/50 mm Hg or >140/100 mm Hg
    • A ventricular rate <60 beats/min or >100 beats/min at rest.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    1-mg group

    2-mg group

    4-mg group

    1-mg elderly group

    Arm Description

    Twelve healthy young subjects were administered a single oral dose of 1 mg minodronic acid tablets at day 1 and then received repeated oral doses of minodronic acid (1 mg) once daily for 7 days (day 3 to day 9).

    Twelve healthy young subjects were administered a single oral dose of 2 mg minodronic acid tablets.

    Twelve healthy young subjects were administered a single oral dose of 4 mg minodronic acid tablets under fasting state at period 1.After a washout period of 8 days, they received the same dosage under fed conditions (administrated 30 minutes before high-fat breakfast).

    Twelve healthy elderly subjects were administered a single oral dose of 1 mg minodronic acid tablets.

    Outcomes

    Primary Outcome Measures

    Cmax
    the maximum observed plasma concentration and
    AUC
    the area under the concentration-time curve

    Secondary Outcome Measures

    adverse events

    Full Information

    First Posted
    November 12, 2014
    Last Updated
    November 19, 2014
    Sponsor
    Wuhan Union Hospital, China
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02295436
    Brief Title
    Pharmacokinetics and Tolerability of Minodronic Acid and Food and Age Effects on the Pharmacokinetics
    Official Title
    Pharmacokinetics and Tolerability of Minodronic Acid Tablets in Healthy Chinese Subjects and Food and Age Effects on the Pharmacokinetics
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2014 (undefined)
    Primary Completion Date
    October 2014 (Actual)
    Study Completion Date
    October 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Wuhan Union Hospital, China

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The primary objective of the the study was to evaluate the pharmacokinetic properties of minodronic acid tablets following single and multiple oral administration in healthy Chinese subjects. Additionally, the effects of age and food on minodronic acid pharmacokinetics was also explored.
    Detailed Description
    This was a single-center, phase I study in healthy young (19-30 years) and elderly (60-65 years) volunteers, which was conducted in four parts. In Part 1, minodronic acid tablets were administered to young volunteers at doses of 1, 2, and 4 mg. In Part 2, after a single dose, young volunteers in the 1-mg dose group received repeated oral doses of minodronic acid once daily for 7 days. In Part 3, a single oral dose of minodronic acid 1 mg was administered to elderly volunteers. In part 4, after a washout period of 8 days, volunteers in the 4-mg dose group received a single dose of 4 mg minodronic acid under fed conditions (administrated 30 minutes before high-fat breakfast). Plasma samples were collected and plasma concentrations of minodronic acid were analyzed by LC-MS/MS. Tolerability was assessed throughout the study by physical examinations, vital signs measurement, laboratory analyses, and monitoring of adverse effects.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoporosis
    Keywords
    minodronic acid, pharmacokinetics, tolerability, food, age, Chinese subjects

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    48 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1-mg group
    Arm Type
    Experimental
    Arm Description
    Twelve healthy young subjects were administered a single oral dose of 1 mg minodronic acid tablets at day 1 and then received repeated oral doses of minodronic acid (1 mg) once daily for 7 days (day 3 to day 9).
    Arm Title
    2-mg group
    Arm Type
    Experimental
    Arm Description
    Twelve healthy young subjects were administered a single oral dose of 2 mg minodronic acid tablets.
    Arm Title
    4-mg group
    Arm Type
    Experimental
    Arm Description
    Twelve healthy young subjects were administered a single oral dose of 4 mg minodronic acid tablets under fasting state at period 1.After a washout period of 8 days, they received the same dosage under fed conditions (administrated 30 minutes before high-fat breakfast).
    Arm Title
    1-mg elderly group
    Arm Type
    Experimental
    Arm Description
    Twelve healthy elderly subjects were administered a single oral dose of 1 mg minodronic acid tablets.
    Intervention Type
    Drug
    Intervention Name(s)
    minodronic acid
    Other Intervention Name(s)
    YM529/ONO-5920
    Intervention Description
    comparison of different doses, ages and medication conditions
    Primary Outcome Measure Information:
    Title
    Cmax
    Description
    the maximum observed plasma concentration and
    Time Frame
    two months
    Title
    AUC
    Description
    the area under the concentration-time curve
    Time Frame
    two months
    Secondary Outcome Measure Information:
    Title
    adverse events
    Time Frame
    two months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Subjects were included based on the following criteria: males or females aged 19 to 35 years for young subjects or aged 60 to 65 years for elderly subjects body mass index between 19 and 24 kg/m2 thorax radiography and ECG with no abnormalities normal blood pressure values heart rate laboratory test results (hematology, blood biochemistry, hepatic function, and urinalysis) negative test results for HIV and hepatitis B. Exclusion Criteria: Subjects were excluded if they had a heart disease or disorder A hepatic, renal, respiratory, immune system, or nervous system disorder Any of the following conditions: pregnancy breast-feeding hypocalcemia prescription or over-the-counter medication use (including herbal products) within 2 weeks before the initiation of the study blood donation or participation in other clinical trials within 3 months before enrollment in the study alcohol or drug abuse smoking more than 10 a day clinically significant allergies to drugs or foods sitting blood pressure <80/50 mm Hg or >140/100 mm Hg A ventricular rate <60 beats/min or >100 beats/min at rest.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Weiyong Li, PhD
    Organizational Affiliation
    Tongji Medical College, Huazhong University of Science and Technology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25748293
    Citation
    Zhou Y, He X, Li H, Ni Y, Xu M, Sattar H, Chen H, Li W. Pharmacokinetics and tolerability of minodronic acid tablets in healthy Chinese subjects and food and age effects on the pharmacokinetics. Clin Ther. 2015 Apr 1;37(4):869-76. doi: 10.1016/j.clinthera.2015.01.015. Epub 2015 Mar 5.
    Results Reference
    derived

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    Pharmacokinetics and Tolerability of Minodronic Acid and Food and Age Effects on the Pharmacokinetics

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