| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Healthy volunteers (Postmenopausal Females and Elderly Males) |
|
| MedDRA Classification |
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| To assess the efficacy of GTx-024 on the lean muscle mass |
|
| E.2.2 | Secondary objectives of the trial |
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
|
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal 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) <30
- agree to return to study center at least 10 times during the outpatient portion of this study
- White blood cell (WBC) Count ≥ 3,000/mm3
- Platelet count ≥ 100,000/mm3
- Serum Creatinine ≤1.5 mg/dL
- FEMALES – be clinically confirmed as postmenopausal
- MALES – over age 60 years of age
- MALES – Subjects must agree to use a double barrier method of contraception during the study and for 3 months after study completion. This may include the following; condom + spermicide, or condom + oral hormonal contraception.
- MALES – have a serum PSA of ≤ 4.0 ng/mL, or a negative prostate biopsy (no prostate cancer) within 6 months of evaluation
|
|
| E.4 | Principal 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
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| E.5 End points |
| E.5.1 | 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). |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Yes |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | Information not present in EudraCT |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | Yes |
| E.6.13.1 | Other scope of the trial description |
|
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | Information not present in EudraCT |
| E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
| E.7.1.3 | Other | Information not present in EudraCT |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | |
| E.8.9.1 | In the Member State concerned months | 6 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 6 |
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