NCT01003444终止1 期
Muscle Biopsy Study In Healthy Subjects For Malonyl Coa Biomarker Assay Development
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Vastus lateralis skeletal muscle samples (>=100 mg but not to exceed 300 mg) will be collected from 12 healthy subjects for provision to the Diabetes Research Unit Translational Biomarker Laboratory.
研究概览
简要总结
Biopsies of the outer thigh muscle and serum samples will be collected from untreated healthy subjects. These biological samples will be provided to the Diabetes Research Unit Translational Biomarker Laboratory for use in developing and validating human muscle malonyl CoA and serum malonate biomarker assays.
详细描述
This non-drug method study was terminated on November 19, 2009. The decision to terminate was based on safety concerns (biopsy-related pain) observed in the first set of subjects. Four subjects were give a sample and did not tolerate it well. No data was collected to report.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests). Female subjects will be of non-childbearing potential.
- •An informed consent document signed and dated by the subject or a legally acceptable representative.
- •Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, allergic, (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing), muscle disease, diabetes, or severe uncontrolled hypertension.
- •Any significant bleeding diathesis which could preclude recovery from the biopsy procedure. ASA, ibuprofen, and any other oral anti platelet agent should be discontinued at least 7 days prior to procedure.
- •Prothrombin time (PT)/INR and/or activated partial thromboplastin time (aPTT) above the respective local laboratory normal ranges.
- •Abnormal CK as per CRU laboratory ranges.
- •Subjects with either a medical history of or physical evidence of keloid scar formation upon physical examination.
- •12 lead ECG demonstrating a clinically significant abnormality.
- •Females of child bearing potential, pregnant or nursing females or females less than 6 months postpartum from the scheduled date of collection.
- •Known hypersensitivity to lidocaine or any component of the study procedure.
- •Participation in non-routine rigorous exercise (eg, road races, heavy lifting, etc.) within one week prior to the muscle biopsy procedures.
- •Professional athletes.
结局指标
主要结局
Vastus lateralis skeletal muscle samples (>=100 mg but not to exceed 300 mg) will be collected from 12 healthy subjects for provision to the Diabetes Research Unit Translational Biomarker Laboratory.
时间窗: 1 day
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
进行中（未招募）
不适用
A study to evaluate muscle tissue, blood, urine and imaging assessments in patients with Late-Onset Pompe Disease treated with alglucosidase alfa.EUCTR2010-020611-36-NLGenzyme Europe B.V.15
进行中（未招募）
不适用
A study to evaluate muscle tissue, blood, urine and imaging assessments in patients with Late-Onset Pompe Disease treated with alglucosidase alfa.Pompe disease (acid alpha-glucosidase deficiency)MedDRA version: 14.1Level: LLTClassification code 10036143Term: Pompe's diseaseSystem Organ Class: 100000004850EUCTR2010-020611-36-DEGenzyme Europe B.V.16
进行中（未招募）
不适用
A study to evaluate muscle tissue, blood, urine and imaging assessments in patients with Late-Onset Pompe Disease treated with alglucosidase alfa.Pompe disease (acid alpha-glucosidase deficiency)MedDRA version: 14.1Level: LLTClassification code 10036143Term: Pompe's diseaseSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2010-020611-36-GBGenzyme Europe B.V.15
尚未招募
不适用
Feasibility of skeletal muscle biopsy and near-infrared spectrometry in post-ICU patients: the Powerhouse feasibility studyPost-Intensive Care SyndroomPost-Intensive Care SyndromeRecovery issues after Intensive Care admission10047635NL-OMON56670Ziekenhuisvoorzieningen Gelderse Vallei5
终止
不适用
Muscle Biopsies in Healthy VolunteersSarcopeniaFrailtyAgingNCT01431677National Institute on Aging (NIA)22