Study to Compare the Bioavailability of Dutasteride Novel Formulation Form to the Soft Gel Capsule Form in Healthy Male Subjects (ARI115148)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01577693
First received: August 11, 2011
Last updated: April 12, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Prostatic Hyperplasia
Drug: dutasteride
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Bioavailability [ Time Frame: 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 ] [ Designated as safety issue: No ]
    To assess the dutasteride relative bioavailability of the of 0.5 mg novel formulation compared with the currently marketed 0.5 mg soft gelatin capsule.


Secondary Outcome Measures:
  • Safety [ Time Frame: Changes from screening to 3 months ] [ Designated as safety issue: No ]
    Changes in blood pressure and pulse rates, review of number of subjects with adverse events, and changes in clinical laboratory data.


Enrollment: 35
Study Start Date: May 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.5 mg novel dose form (test)
0.5 mg novel dose form (test)
Drug: dutasteride
novel dutasteride
0.5 mg Soft Gel Capsule
0.5 mg Soft Gel Capsule (reference)
Drug: dutasteride
dutasteride soft gel capsule

Detailed Description:

The purpose of this study is to determine the bioavailability of 0.5mg dutasteride in a novel formulation compared to the currently marketed 0.5mg dutasteride soft gel capsule in fasted healthy male subjects. This will be an open-label, single dose, randomized, two-period crossover study in healthy male subjects. Subjects will receive a single oral dose 0.5mg novel dutasteride formulation and a single oral dose 0.5mg dutasteride soft gel capsule in a fasted state. Each dose of the study medication will be separated by a 28-day washout period. Blood samples for pharmacokinetic analysis will be taken at regular intervals after dosing. Safety will be assessed by measurement of blood pressure, heart rate, laboratory data, and review of adverse events. The study will enrol approximately 35 healthy male subjects to ensure that 30 subjects complete the study. The study will be conducted in the USA.

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01577693

Locations
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78744
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01577693     History of Changes
Other Study ID Numbers: 115148
Study First Received: August 11, 2011
Last Updated: April 12, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
dutasteride
cross over study
bioavailability

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Dutasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014