Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride

NCT00400335 | Completed Phase 1

• 1 other identifier: TDC106222
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The combination of testosterone and dutasteride is intended for use in hypogonadal men. This study will evaluate the bioavailability and pharmacokinetics of various doses of testosterone administered with and without dutasteride

Conditions

Hypogonadism; Hypogonadism, Male

Keywords

Testosterone; Men; Hypogonadism; Dutasteride; DHT; Androgen deficiency

Outcome Measures

Primary Outcomes (1)

• lab tests for relative bioavailability of testosterone and dutasteride,

  days 1, 2, 3, 19, 20, 21 & 26-31

Secondary Outcomes (2)

• safety lab tests of various testosterone/dutasteride formulations,

  days 1, 2, 3, 19, 20, 21 & 26-31.

• lab tests for additional pharmacokinetic parameters for testosterone & dutasteride,

  days 1, 2, 3, 19, 20, 21 & 26-31.

Interventions

Nanomilled testosterone DRUG

commercially available dutasteride DRUG

Nanomilled dutasteride DRUG

Also known as: commercially available dutasteride, Nanomilled testosterone

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Are healthy.
• Have a BMI within range of 19-32 kg/m2.
• Have not taken dutasteride for one year, or finasteride for the past 3 months.
• Have a screening PSA \< 2.0ng/mL.

You may not qualify if:

• Have had or have breast or prostate cancer, sleep apnea, psychiatric illness, or any other clinically significant current condition.
• Have a trigliceride level =500mg/dL.
• Have abnormal thyroid or hormone levels.
• Would donate more than 500 ML of blood over a 2 month period.
• Physician does not think it is a good idea for you to participate in the trial.
• Are unwilling to abstain from alcohol during the study.
• Have a positive urine drug screen test.
• Plan to change your smoking habits during the course of the trial.
• Have Hepatitis C, Hepatitis B, or HIV.
• Have a lab or ECG abnormality.
• Have high or low blood pressure.
• Have used of any investigational drug or device during the study or within 30 days prior to 1st dosing of study medication.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Tacoma, Washington, 98418, United States

Location

MeSH Terms

Conditions

Hypogonadism; Eunuchism; Multiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 14, 2006
• First Posted: November 16, 2006
• Study Start: October 1, 2006
• Last Updated: June 4, 2012

Record last verified: 2011-02

Locations

US (1)