Muscle Malonyl Coa Biomarker Assay Development
This study has been terminated.
(See termination reason in detailed description.)
Information provided by:
First received: October 14, 2009
Last updated: November 23, 2010
Last verified: December 2009
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.
Procedure: Muscle biopsy
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
||Muscle Biopsy Study In Healthy Subjects For Malonyl Coa Biomarker Assay Development
Primary Outcome Measures:
- 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. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||November 2009 (Final data collection date for primary outcome measure)
Experimental: Cohort 1
Muscle biopsy in healthy volunteers
Procedure: Muscle biopsy
Collection of muscle biopsies of the vastus lateralis will be performed by a consulting specialist. The first muscle biopsy (Day 1, 2 hour) will be obtained from the vastus lateralis muscle of the non-dominant leg. The second biopsy (Day 1, 4 hour) will be obtained from the same vastus lateralis muscle on the same leg approximately 10 centimeters from the first muscle biopsy site.
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.
|Ages Eligible for Study:
||18 Years to 55 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01003444
|Pfizer Investigational Site
|New Haven, Connecticut, United States, 06511 |
||Pfizer CT.gov Call Center
No publications provided
||Director, Clinical Trial Disclosure Group, Pfizer, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 14, 2009
||November 23, 2010
||United States: Food and Drug Administration
Keywords provided by Pfizer:
ClinicalTrials.gov processed this record on December 09, 2013
Muscle biopsy Malonyl CoA Biomarker assay