Last updated: 11/07/2018 08:39:44

Study to compare the bioavailability of dutasteride novel formulation form to the soft gel capsule form in healthy male subjectsARI115148

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GSK study ID
115148
See study documents
Clinicaltrials.gov ID
NCT01577693
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An open-label, single dose, randomized, two-period crossover study to investigate the bioavailability of a novel dosage form of dutasteride in healthy male subjects
Trial description: The purpose of this study is to determine the bioavailability of 0.5mg dutasteride novel formulation compared to the currently marketed 0.5mg dutasteride soft gel capsule in fasted healthy male subjects.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Bioavailability

Timeframe: Change from Day 1 (session 1) compared to Day 29 (session 2), predose, .25, .5, .75, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72

Secondary outcomes:

Safety

Timeframe: Changes from screening to 3 months

Interventions:
  • Drug: dutasteride
    • Enrollment:
    35
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Prostatic Hyperplasia
    Product
    dutasteride
    Collaborators
    Not applicable
    Study date(s)
    May 2011 to August 2011
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Male
    Age
    20 - 45 years
    Accepts healthy volunteers
    Yes
    • Healthy as determined by a responsible and experienced physician.
    • Males between 20 and 45 years of age inclusive, at the time of signing the informed consent form.
    • History of postural hypotension, dizziness, poor hydration, vertigo, vaso-vagal reactions or any other signs and symptoms of orthostasis.
    • Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Healthy as determined by a responsible and experienced physician.
    • Males between 20 and 45 years of age inclusive, at the time of signing the informed consent form.
    • Male subjects with female partners of child-bearing potential must agree to use one of the contraception.
    • Body mass index within the range 18-30 kg/m2 (inclusive); weight range 55-95 kg (inclusive).
    • Capable of giving written informed consent.
    • Single QTcB < 450 msec.
    • Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, and bilirubin less than or equal to 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
    Exclusion criteria:
    • History of postural hypotension, dizziness, poor hydration, vertigo, vaso-vagal reactions or any other signs and symptoms of orthostasis.
    • Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
    • A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
    • A positive test for human immunodeficiency virus (HIV) antibody.
    • Subject is mentally or legally incapacitated.
    • Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements.
    • History of sensitivity to dutasteride, components thereof or drugs of this class or a history of drug or other allergy.
    • History of sensitivity to heparin or heparin-induced thrombocytopenia
    • The subject has participated in a clinical trial for 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
    • Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
    • A positive pre-study drug/alcohol screen.
    • History of regular alcohol consumption.
    • Consumption of red wine, grapefruit juice, grapefruit and related hybrids, and jufen grapes.
    • The subject has donated blood or blood products in excess of 500 mL within a 56 day period.
    • Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months.
    • Unwillingness or inability to follow the procedures outlined in the protocol.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Austin, Texas, United States, 78744
    Status
    Study Complete
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2011-31-08

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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    Additional information
    Results for study 115148 can be found on the GSK Clinical Study Register.
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