Healthy volunteers (Postmenopausal Females and Elderly Males)
Conditions
Interventions
Product Name: GTx-024
Pharmaceutical Form: Powder and solvent for oral solution
Current Sponsor code: GTx-024
Concentration unit: mg/ml milligram(s)/mil
Sponsors
GTx Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible for participation in this study, subjects must meet all of the following criteria: - give voluntary, signed informed consent in accordance with institutional policies - be non-obese as defined as body mass index (BMI) =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects with any of the following will NOT be eligible for enrollment in this study: - have evidence of cancer (local, regional and/or distant metastasis) - have a history of cancer (exceptions include non-melanoma skin cancer or other cancer that has no evidence of solid tumor reoccurrence 5 years after definitive treatment) - have a history of clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to the study drug or drugs similar to the study drug - have, in the judgment of the Investigator, a clinically significant concurrent illness or psychological, familial, sociological, geographical or other concomitant condition that would not permit adequate follow-up and compliance with the study protocol - concurrently being treated with other investigational agents or have participated in an investigational study involving drugs or devices within 60 days prior to screening - history of active chronic hepatitis, hepatic cirrhosis, or HIV infection - known hypersensitivity or allergy to testosterone-like drugs (excluding skin sensitivities do to gel or skin patch as well as injection site reactions) - Any disease or condition (medical or surgical) which might compromise the hematologic, cardiovascular, endocrine, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk - The presence of abnormal laboratory values which are considered clinically significant. In addition, no subject with liver enzymes (ALT/SGOT or AST/SGPT) above 1.25 times the upper limit of normal, total bilirubin above the upper limit of normal, or tests of hematologic function (hemoglobin, hematocrit, white blood cells or platelets) below the lower limit of normal will be admitted to the study. - Positive screen for Hepatitis B consisting of HBsAg (Hepatitis B Surface Antigen), anti-HCV (Hepatitis C Antibody), hepatitis A antibody IgM, or HIV - Have a history of drug or alcohol abuse [Alcohol consumption averaging > 2 drinks daily ( 1drink is 12 oz of beer, 4 oz of wine or 1.5 oz of spirits)], within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during screening and baseline procedures; - Currently taking testosterone, testosterone-like agents (such as DHEA, androstenedione, and other androgenic compounds, including herbals), or antiandrogens (Please note that previous therapy with testosterone and testosterone-like agents is acceptable with a 30 day wash-out. However, if the previous testosterone therapy was a long term depot, within the past 6 months, the site should call the medical monitor for this study to determine appropriate washout period.) - Females that have an occupation that a possible change of voice would be detrimental to that occupation. - Have a history of sleep apnea syndrome - Donated blood or blood products within 90 days prior to dosing - Received an investigational drug within a period of 90 days prior to dosing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of GTx-024 on the lean muscle mass; Secondary Objective: To assess the efficacy of GTx-024 on bone mineral density To assess the efficacy of GTx-024 on total body weight To assess the efficacy of GTx-024 on fat mass To assess the efficacy of GTx-024 on muscle function (performance) To assess the efficacy of GTx-024 on muscle function (movement) To assess the effect of GTx-024 on serum bone turnover markers To assess the effect of GTx-024 on sebum production To assess the effect of GTx-024 on glucose metabolism To assess the effect of GTx-024 on appetite To assess the effect of GTx-024 on lipids To assess the effect of GTx-024 on serum hormones To assess the effect of GTx-024 on hair growth in females (hirsutism) To assess the effect of GTx-024 on mRNA levels of ALT, AST, and 18S in a subset of the male and female population NOTE: The muscle biopsy assessment is optional for the study participants. To assess the safety and tolerability of GTx-024 To assess the single dose and multiple dose pharmacokinetics of GTx-024 ;Primary end point(s): To assess the efficacy of GTx-024 on the lean muscle mass as measured by dual energy x-ray absorptiometry (DEXA). | — |
Countries
Germany, United Kingdom
Outcome results
None listed