Healthy VolunteersPhase 1NCT01003444
Muscle Malonyl Coa Biomarker Assay Development
A Phase 1 study testing Muscle biopsy in people with Healthy Volunteers, run by Pfizer at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Muscle biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Nov 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
New Haven, Connecticut, 06511
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- Muscle biopsy
- Keywords
- Muscle biopsy Malonyl CoA Biomarker assay
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle biopsyProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Muscle biopsy in healthy volunteers Receives: Procedure: Muscle biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2009 (estimated)
- Study startNov 2009
- Primary completionNov 2009
- Study completionNov 2009
Why it stopped: See termination reason in detailed description.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01003444
- Sponsor's protocol ID
- B1501004
- Status last verified
- Dec 2009
- First submitted
- 14 Oct 2009
- Last updated
- 24 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Biopsy Study In Healthy Subjects For Malonyl Coa Biomarker Assay Development
- ClinicalTrials.gov ID
- NCT01003444
- Acronym / sponsor ID
- B1501004
- Conditions
- Healthy Volunteers
- Keywords
- Muscle biopsy Malonyl CoA Biomarker assay
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 28 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Procedure: Muscle biopsyMuscle biopsy in healthy volunteers |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscle biopsyCollection 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. | Procedure or surgery | Cohort 1 |
Primary outcome
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
Results and safety
The study was stopped early (reason given: See termination reason in detailed description.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2010.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Muscle biopsy in people with Healthy Volunteers, run by Pfizer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: See termination reason in detailed description.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2010.