Study to Compare the Bioavailability of Dutasteride Novel Formulation Form to the Soft Gel Capsule Form in Healthy Male Subjects
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostatic Hyperplasia
Intervention: dutasteride (Drug); dutasteride (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Summary
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Bioavailability
Secondary outcome: Safety
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
Minimum age: 20 Years.
Maximum age: 45 Years.
Gender(s): Male.
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.
Locations and Contacts
GSK Investigational Site, Austin, Texas 78744, United States
Additional Information
Starting date: May 2011
Last updated: April 12, 2012
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