EUCTR2006-001001-28-DE进行中（未招募）不适用
Double-blind, placebo controlled, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of GTx-024 in Postmenopausal Females and Elderly Males
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- GTx Inc
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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
研究者
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