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

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

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.

Study Overview

• Status: Completed
• Conditions: Prostatic Hyperplasia
• Intervention / Treatment: Drug: dutasteride; Drug: dutasteride

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78744
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0.5 mg novel dose form (test)	Drug: dutasteride; novel dutasteride; Drug: dutasteride; dutasteride soft gel capsule
Other: 0.5 mg Soft Gel Capsule; 0.5 mg Soft Gel Capsule (reference)	Drug: dutasteride; novel dutasteride; Drug: dutasteride; dutasteride soft gel capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	Changes in blood pressure and pulse rates, review of number of subjects with adverse events, and changes in clinical laboratory data.	Changes from screening to 3 months

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2011
• Primary Completion (Actual): August 31, 2011
• Study Completion (Actual): August 31, 2011

Study Registration Dates

• First Submitted: August 11, 2011
• First Submitted That Met QC Criteria: April 12, 2012
• First Posted (Estimate): April 16, 2012

Study Record Updates

• Last Update Posted (Actual): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: bioavailability; dutasteride; cross over study
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Steroid Synthesis Inhibitors; 5-alpha Reductase Inhibitors; Dutasteride
• Other Study ID Numbers: 115148

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Clinical Study Report
   Information identifier: 115148
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Informed Consent Form
   Information identifier: 115148
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Individual Participant Data Set
   Information identifier: 115148
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Study Protocol
   Information identifier: 115148
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Annotated Case Report Form
   Information identifier: 115148
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Dataset Specification
   Information identifier: 115148
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Statistical Analysis Plan
   Information identifier: 115148
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register