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

Completed · Phase 1

Conditions studied: Prostatic Hyperplasia

In brief

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.

Key facts

Study ID

NCT01577693

Run by

GlaxoSmithKline

People needed

35

Starts

2011-05-12

Expected to finish

2011-08-31

Last updated by the study team

2018-06-19

Who can join

Age: 20 and older, up to 45. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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%).

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Austin, Texas, United States

Full record on ClinicalTrials.gov

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