Muscle Malonyl Coa Biomarker Assay Development

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01003444
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : October 28, 2009
Last Update Posted : November 24, 2010
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Procedure: Muscle biopsy Phase 1

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Muscle Biopsy Study In Healthy Subjects For Malonyl Coa Biomarker Assay Development
Study Start Date : November 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01003444

United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT01003444     History of Changes
Other Study ID Numbers: B1501004
First Posted: October 28, 2009    Key Record Dates
Last Update Posted: November 24, 2010
Last Verified: December 2009

Keywords provided by Pfizer:
Muscle biopsy Malonyl CoA Biomarker assay