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Muscle Malonyl Coa Biomarker Assay Development

Last updated on March 14, 2019

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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.
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- 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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[email protected]

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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