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Muscle Malonyl Coa Biomarker Assay Development

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01003444
Pfizer
Terminated
Muscle Malonyl Coa Biomarker Assay Development

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Muscle Malonyl Coa Biomarker Assay Development
Muscle Biopsy Study In Healthy Subjects For Malonyl Coa Biomarker Assay Development
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.
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.
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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.
Experimental: Cohort 1
Muscle biopsy in healthy volunteers
Intervention: Procedure: Muscle biopsy
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
November 2009
November 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01003444
B1501004
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

BY EMAIL

Contact

[email protected]



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