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

NCT01577693 | Completed Phase 1

• 1 other identifier: 115148
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostatic Hyperplasia

Keywords

dutasteride; cross over study; bioavailability

Outcome Measures

Primary Outcomes (1)

• Bioavailability

  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.

  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 (1)

• Safety

  Changes from screening to 3 months

Study Arms (2)

0.5 mg novel dose form (test)

EXPERIMENTAL

0.5 mg novel dose form (test)

Drug: dutasteride

0.5 mg Soft Gel Capsule

OTHER

0.5 mg Soft Gel Capsule (reference)

Drug: dutasteride

Interventions

dutasteride DRUG

novel dutasteride

0.5 mg novel dose form (test)

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Austin, Texas, 78744, United States

Location

Related Links

• Results for study 115148 can be found on the GSK Clinical Study Register.
• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Dutasteride

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Azasteroids; Steroids, Heterocyclic; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2011
• First Posted: April 16, 2012
• Study Start: May 12, 2011
• Primary Completion: August 31, 2011
• Study Completion: August 31, 2011
• Last Updated: June 19, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)