EUCTR2017-001148-37-GB进行中（未招募）1 期
A randomized, double-blind (sponsor unblind), placebo-controlled, multi-centered phase IIa study to evaluate the safety and efficacy of 13 weeks of once daily oral dosing of the selective androgen receptor modulator (SARM) GSK2881078 in older men and post menopausal women with COPD and muscle weakness, participating in home exercise.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 96
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
- •1. Participants must be 50 to 75 years of age inclusive, at the time of signing the informed consent.
- •2. Male and/or female:
- •a. Male participants: A male participant with a partner who is a woman of child bearing potential (WOCPB) must agree to use contraception as detailed below during the treatment period and for at least 5 half-lives of study medication have passed after the last ingested dose [125 days, corresponding to time needed to eliminate study treatment for both genotoxic and teratogenic study treatments plus an additional 90 days (a spermatogenesis cycle) for study treatments with genotoxic potential] after the last dose of study treatment and refrain from donating sperm during this period.
- •- Male participants with female partners of child-bearing potential are eligible to participate if they agree to ONE of the following during the protocol-defined time frame described above:
- •- Are abstinent from penile-vaginal intercourse as their usual and preferred lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception.
- •- Agree to use a male condom plus an additional method of contraception with a failure rate of <1% per year when having penilevaginal intercourse with a woman of childbearing potential
- •- Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile penetration during the protocol-defined time frame
- •- Refrain from donating sperm for duration of study and for 4 months from last dose
- •b. Female participants: A female participant is eligible to participate if she is post-menopausal and not a woman of childbearing potential (WOCBP) as defined below.
- •Woman of Childbearing Potential (WOCBP) A woman is considered fertile following menarche and until becoming post-menopausal unless permanently sterile.
- •Women in the following categories are not considered WOCBP
- •1.Premenarchal
- •2.Premenopausal female with ONE of the following:
- •- Documented hysterectomy
- •- Documented bilateral salpingectomy
- •- Documented bilateral oophorectomy
- •3.Postmenopausal female
- •-A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy (HRT). However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
- •-Females on HRT and whose menopausal status is in doubt will be required to use one of the non-hormonal highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status before study enrollment.
- •. Note: Postmenopausal is defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) levels consistent with menopause (refer to laboratory reference ranges for confirmatory levels), or be >60 years of age].
- •3. Confirmed diagnosis of COPD in accordance with the ATS/ERS criteria with a post-bronchodilator FEV1/ forced vital capacity (FVC) < 0.70 AND 30%= FEV1% predicted =65% of predicted norm
排除标准
- •1. Participants with a history of myocardial infarction, angina, congestive heart failure exacerbation, hospitalization for cardiac aetiology, stroke or transient ischemic attack in the past 12 months.
- •2. Neurologic, musculoskeletal, osteoarthritis, or any other condition that in the opinion of the investigator limits participant’s ability to complete study physical assessments.
- •3. Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- •4. Participants with a history of cholecystectomy.
- •5. Participants with a history of malignancy that is not in complete remission for at least 2 years or 1 year for non-melanoma skin carcinoma.
- •6. Participants with a family history of early onset prostate cancer or familial prostate cancer (multiple family members).
- •7. Diseases known to cause malabsorption of protein or energy, such as inflammatory
- •bowel disease, celiac disease, pancreatic insufficiency, etc.
- •8. Current or planned administration of cholestyramine or strong oral or injectable cytochrome P-450 isoenzyme 3A4 (CYP3A4) inducers.
- •9. Current or planned use of any prescription drugs known to affect muscle mass, including androgen supplements, anti-androgens (such as LHRH agonists), antiestrogens (tamoxifen, etc.), recombinant growth hormone, megesterol, etc.
- •10. Use of oral steroids concurrently or within 4 weeks preceding the screening visit.
- •11. The participant has participated in a clinical trial and has received an investigational product within the following time period prior to randomization in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- •12. Participants with values outside the specified ranges for the following Key Clinical Laboratory Tests must be excluded from the study:
- •Renal function: Glomerular Filtration Rate (GFR) <30 (mL/min/1.73 m2 ) using formulae provided in the Study Reference Manual (SRM). Note: Participants receiving dialysis are excluded from this study.
- •Metabolic – HbA1c >7.5%.
- •ALT >2xULN and bilirubin >1.5xULN (isolated bilirubin >1.5xULN is
- •acceptable if bilirubin is fractionated and direct bilirubin <35%).
- •Haematology – Haemoglobin <10.0 g/dL at screening
- •Prostate Specific Antigen >4.0 ng/mL
- •13. Presence of hepatitis B surface antigen, positive hepatitis C antibody test
- •result at screening or within 3 months prior to first dose of study treatment. NOTE: Participants with positive Hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C RNA PCR test is obtained.
- •14. QT interval corrected for heart rate by Bazett's formula or QT interval corrected for heart rate by Fridericia’s formula >450 msec or QT interval corrected for heart rate >480 msec in participants with Bundle Branch Block based on a single ECG.
- •15. A positive test for HIV antibody.
- •16. More than two moderate/severe COPD exacerbations within the past year
- •Exacerbation is defined as worsening of two or more of the following major
- •symptoms: dyspnoea, sputum volume, sputum purulence OR worsening of any one major symptom together with at least one of the following additional
- •symptoms: sore throat, colds (nasal discharge and/or nasal congestion), fever >37.5oC without any explained cause, increased cough, increased wheeze.
- •A moderate exacerbation is defined as an exacerbation that requires treatment with an
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