HealthyPhase 1PBTNCT01807702
13C-Pyruvate Breath Test
A Phase 1 study testing 13C-Pyruvate 13C-lactate and dichloroacetate in people with Healthy, run by University of Florida at 1 site in United States.
Trial summary
The purpose of the test is to measure an enzyme called pyruvate. Subjects will fast for 12 hours and then undergo a breath test, have blood drawn, and cells from the inside of the mouth collected over a 12 hour period. The tests will be repeated at least a week later and subjects receive a dose of dichloroacetate (DCA) Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 13C-Pyruvate 13C-lactate and dichloroacetate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Jul 2013
- 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 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- normal history,
- normal physical
- normal baseline laboratory data.
Who cannot join
- Any illness
- Chronic health condition
- Use of street drugs
- Taking medication
- Abnormal labs Abnormal physical exam -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 13C-Pyruvate Breath Test Pilot Study
The purpose of the test is to measure an enzyme called pyruvate. Subjects will fast for 12 hours and then undergo a breath test, have blood drawn, and cells from the inside of the mouth collected over a 12 hour period. The tests will be repeated at least a week later and subjects receive a dose of dichloroacetate (DCA)
Read the detailed description
Subjects will be screened with a history and physical and have baseline laboratory values drawn to assure that the subject is healthy.Subjects will fast for 12 hours before the test. The next day they will receive a dose of 25mg of pyruvate dissolved in 80ml of Crystal Light. The pyruvate used in this study will be prepared with a nonradioactive form of carbon, called a stable isotope. It poses no hazard to the subject's health. About 50 mls of blood will be drawn over a 120 minute time period from an IV catheter placed in the arm. Subjects will also be asked to exhale into a plastic tube about 12 times in 120 minutes to collect 13C carbon dioxide (13CO2). Cells from inside of the mouth will be collected by subjects swishing a tablespoon of mouth wash for one minute and then spitting it into a sterile plastic tube. At least one week following the first admission subjects will return to repeat the above procedure and receive 25mg of dichloroacetate (DCA) one hour before receiving the pyruvate. Then the same samples will be collected. Subjects have the option of doing the tests 4 times receiving the DCA on the last visit.
- Conditions
- Healthy
- Being tested
- 13C-Pyruvate 13C-lactate and dichloroacetate
- Keywords
- dichloroacetate, pyruvate, lactate, pyruvate dehydrogenase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
13C-Pyruvate 13C-lactate and dichloroacetateDrug
Also called dichloroacetate, pyruvate, CO2 collection
Subjects will receive pyruvate and have blood,CO2, and buccal cell samples collected. The second visit the subjects will receive a dose of dichloroacetate before the pyruvate is given
| Study group | Role | What they receive |
|---|---|---|
| 13C-pyruvate,13C-Lactate and dichloroacetate | Experimental | During the first day of the subjects participation pyruvate will be given and blood, breath and buccal cell samples will be collected over a two hour period. On the last day DCA will be given. Receives: Drug: 13C-Pyruvate 13C-lactate and dichloroacetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of dichloroacetate on pyruvate dehydrogenase and 13C02 production.
Dichloroacetate is an activator of pyruvate dehydrogenase (PDH). It will be administered to the patient who will then undergo the pyruvate breath test to measure the amount of 13CO2 expressed. The activity of 13CO2 as measured by a concentration curve will reflect PDH activity.
Measured: Baseline to one year
Secondary outcomes (2)
Blood Lactate levels and 13CO2 Response to DCA
There will be a correlation between blood lactate levels and 13CO2 in response to DCA administration by comparing CO2 breath peaks in the concentration curve compared to serum lactate levels for same time period.
Measured: Baseline to one year
Conversion of 13C pyruvate to 13C pyruvate
There will be no reduction in the conversion of 13C-pyruvate to 13C-lactate in blood in response to DCA administration.
Measured: Baseline to One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter W. Stacpoole, PhD, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807702
- Sponsor's protocol ID
- IRB# 654-10
- Acronym
- PBT
- Status last verified
- Nov 2015
- First submitted
- 22 Feb 2013
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 13C-Pyruvate Breath Test Pilot Study
- ClinicalTrials.gov ID
- NCT01807702
- Acronym / sponsor ID
- PBT / IRB# 654-10
- Conditions
- Healthy
- Keywords
- dichloroacetate, pyruvate, lactate, pyruvate dehydrogenase
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 8 Mar 2013 (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.
The purpose of the test is to measure an enzyme called pyruvate. Subjects will fast for 12 hours and then undergo a breath test, have blood drawn, and cells from the inside of the mouth collected over a 12 hour period. The tests will be repeated at least a week later and subjects receive a dose of dichloroacetate (DCA)
Detailed description
Subjects will be screened with a history and physical and have baseline laboratory values drawn to assure that the subject is healthy.Subjects will fast for 12 hours before the test. The next day they will receive a dose of 25mg of pyruvate dissolved in 80ml of Crystal Light. The pyruvate used in this study will be prepared with a nonradioactive form of carbon, called a stable isotope. It poses no hazard to the subject's health. About 50 mls of blood will be drawn over a 120 minute time period from an IV catheter placed in the arm. Subjects will also be asked to exhale into a plastic tube about 12 times in 120 minutes to collect 13C carbon dioxide (13CO2). Cells from inside of the mouth will be collected by subjects swishing a tablespoon of mouth wash for one minute and then spitting it into a sterile plastic tube. At least one week following the first admission subjects will return to repeat the above procedure and receive 25mg of dichloroacetate (DCA) one hour before receiving the pyruvate. Then the same samples will be collected. Subjects have the option of doing the tests 4 times receiving the DCA on the last visit.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 13C-pyruvate,13C-Lactate and dichloroacetate | Experimental | Drug: 13C-Pyruvate 13C-lactate and dichloroacetateDuring the first day of the subjects participation pyruvate will be given and blood, breath and buccal cell samples will be collected over a two hour period. On the last day DCA will be given. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- normal history,
- normal physical
- normal baseline laboratory data.
Key exclusion criteria (5 listed)
- Any illness
- Chronic health condition
- Use of street drugs
- Taking medication
- Abnormal labs Abnormal physical exam -
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 |
|---|---|---|
| 13C-Pyruvate 13C-lactate and dichloroacetateAlso: dichloroacetate, pyruvate, CO2 collectionSubjects will receive pyruvate and have blood,CO2, and buccal cell samples collected. The second visit the subjects will receive a dose of dichloroacetate before the pyruvate is given | Drug | 13C-pyruvate,13C-Lactate and dichloroacetate |
Primary outcome
Effect of dichloroacetate on pyruvate dehydrogenase and 13C02 production.
Time frame: Baseline to one year
Dichloroacetate is an activator of pyruvate dehydrogenase (PDH). It will be administered to the patient who will then undergo the pyruvate breath test to measure the amount of 13CO2 expressed. The activity of 13CO2 as measured by a concentration curve will reflect PDH activity.
2 secondary outcomes
Blood Lactate levels and 13CO2 Response to DCA
Time frame: Baseline to one year
Conversion of 13C pyruvate to 13C pyruvate
Time frame: Baseline to One Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
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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.
Peter W. Stacpoole, PhD, MD principal investigator
University of Florida
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 13C-Pyruvate 13C-lactate and dichloroacetate in people with Healthy, run by University of Florida 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 5 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: finished, as of the sponsor's last update on 2 Dec 2015. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effect of dichloroacetate on pyruvate dehydrogenase and 13C02 production. (time frame: Baseline to one year). 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 2 Dec 2015.