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
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
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
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Location
GSK Investigational Site
Austin, Texas, United States, 78744
Status
Study Complete
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Study documents

Scientific result summary
Available language(s): English
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If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
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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