ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
Adult Trials: 18+ Years
- 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.
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Muscle Malonyl Coa Biomarker Assay Development | |||
| Official Title ICMJE | Muscle Biopsy Study In Healthy Subjects For Malonyl Coa Biomarker Assay Development | |||
| 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. | |||
| 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 ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 1 | |||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Basic Science | |||
| Condition ICMJE | Healthy Volunteers | |||
| Intervention ICMJE | 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. | |||
| Study Arms ICMJE | Experimental: Cohort 1
Muscle biopsy in healthy volunteers Intervention: Procedure: Muscle biopsy | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Terminated | |||
| Actual Enrollment ICMJE | 4 | |||
| Original Estimated Enrollment ICMJE | 12 | |||
| Actual Study Completion Date ICMJE | November 2009 | |||
| Actual Primary Completion Date | November 2009 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years to 55 Years (Adult) | |||
| Accepts Healthy Volunteers ICMJE | Yes | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01003444 | |||
| Other Study ID Numbers ICMJE | B1501004 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | December 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||