Muscle Malonyl Coa Biomarker Assay Development

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01003444
First received: October 14, 2009
Last updated: November 23, 2010
Last verified: December 2009
  Purpose

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 Intervention Phase
Healthy Volunteers
Procedure: Muscle biopsy
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Muscle Biopsy Study In Healthy Subjects For Malonyl Coa Biomarker Assay Development

Further study details as provided by Pfizer:

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 ]

Enrollment: 4
Study Start Date: November 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01003444

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01003444     History of Changes
Other Study ID Numbers: B1501004
Study First Received: October 14, 2009
Last Updated: November 23, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Muscle biopsy Malonyl CoA Biomarker assay

ClinicalTrials.gov processed this record on August 26, 2014