Type 2 Diabetes Mellitus (T2DM)Phase 1NCT01127308
A Radiolabeled Mass Balance Study of [14C]-Ertugliflozin (PF04971729, MK-8835) In Healthy Male Participants (MK-8835-038)
A Phase 1 study testing Ertugliflozin in people with Type 2 Diabetes Mellitus (T2DM), run by Merck Sharp & Dohme LLC.
Trial summary
This is single dose study of radiolabeled [14C]-ertugliflozin (PF04971729, MK-8835) in healthy male volunteers to study the absorption, distribution, metabolism and elimination of ertugliflozin. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Ertugliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to Jul 2010
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male participants with Body Mass Index of 17.5 to 30.5 kg/m2 and a total body weight >50 kg (110 lbs)
Who cannot join
- Female participants. Participants enrolled in a previous radionucleotide study or who have received radiotherapy or exposed to significant radiation within 12 months prior to screening
About this study
Official title: An Open Label, Single-Period, Phase 1 Study To Evaluate The Pharmacokinetics, Excretion Balance And Metabolism Of [14C]-PF04971729 In Healthy Adult Male Subjects
This is single dose study of radiolabeled [14C]-ertugliflozin (PF04971729, MK-8835) in healthy male volunteers to study the absorption, distribution, metabolism and elimination of ertugliflozin.
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- Ertugliflozin
- Keywords
- Absorption, Distribution, Metabolism, and Excretion, Mass Balance, Metabolic Profile, Radiolabel Study
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErtugliflozinDrug
Ertugliflozin 25 mg will be administered as a single oral suspension containing approximately 100 uCi of [14C]ertugliflozin
| Study group | Role | What they receive |
|---|---|---|
| [14C]Ertugliflozin | Experimental | Single dose - oral dosing suspension Receives: Drug: Ertugliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percent of Dose Recovered in Urine and Feces Following a Single Oral Dose of [^14C]Ertugliflozin (100 µCi).
Measured: Up to 7 Days
Area under the plasma concentration-time curve (AUC) from time 0 to time of the last quantifiable concentration (AUClast) for ertugliflozin
Measured: Up to 7 Days
AUC from Hour 0 to infinity (AUCinf) for ertugliflozin
Measured: Up to 7 Days
Maximum plasma concentration (Cmax) of ertugliflozin
Measured: Up to 7 Days
Time taken to reach the maximum observed plasma concentration (Tmax) of ertugliflozin
Measured: Up to 7 Days
Ertugliflozin half life (t1/2)
Measured: Up to 7 Days
Amount of Ertugliflozin and metabolites in plasma, urine, and feces
Measured: Up to 7 Days
Number of Participants Experiencing an Adverse Event (AE)
Measured: Up to 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2010 (estimated)
- Study startJun 2010
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01127308
- Sponsor's protocol ID
- 8835-038
- Status last verified
- Mar 2016
- First submitted
- 19 May 2010
- Last updated
- 23 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Fediuk DJ, Sahasrabudhe V, Dawra VK, Zhou S, Sweeney K. Population Pharmacokinetic Analyses of Ertugliflozin in Select Ethnic Populations. Clin Pharmacol Drug Dev. 2021 Nov;10(11):1297-1306. doi: 10.1002/cpdd.970. Epub 2021 Jul 2.
PubMed 34213819Marshall JC, Liang Y, Sahasrabudhe V, Tensfeldt T, Fediuk DJ, Zhou S, Krishna R, Dawra VK, Wood LS, Sweeney K. Meta-Analysis of Noncompartmental Pharmacokinetic Parameters of Ertugliflozin to Evaluate Dose Proportionality and UGT1A9 Polymorphism Effect on Exposure. J Clin Pharmacol. 2021 Sep;61(9):1220-1231. doi: 10.1002/jcph.1866. Epub 2021 Jun 19.
PubMed 33813736
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single-Period, Phase 1 Study To Evaluate The Pharmacokinetics, Excretion Balance And Metabolism Of [14C]-PF04971729 In Healthy Adult Male Subjects
- ClinicalTrials.gov ID
- NCT01127308
- Acronym / sponsor ID
- 8835-038
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Keywords
- Absorption, Distribution, Metabolism, and Excretion, Mass Balance, Metabolic Profile, Radiolabel Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- Jun 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 20 May 2010 (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.
This is single dose study of radiolabeled [14C]-ertugliflozin (PF04971729, MK-8835) in healthy male volunteers to study the absorption, distribution, metabolism and elimination of ertugliflozin.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]Ertugliflozin | Experimental | Drug: ErtugliflozinSingle dose - oral dosing suspension |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male participants with Body Mass Index of 17.5 to 30.5 kg/m2 and a total body weight >50 kg (110 lbs)
Key exclusion criteria (1 listed)
- Female participants. Participants enrolled in a previous radionucleotide study or who have received radiotherapy or exposed to significant radiation within 12 months prior to screening
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 |
|---|---|---|
| ErtugliflozinErtugliflozin 25 mg will be administered as a single oral suspension containing approximately 100 uCi of [14C]ertugliflozin | Drug | [14C]Ertugliflozin |
Primary outcome
Mean Percent of Dose Recovered in Urine and Feces Following a Single Oral Dose of [^14C]Ertugliflozin (100 µCi).
Time frame: Up to 7 Days
Area under the plasma concentration-time curve (AUC) from time 0 to time of the last quantifiable concentration (AUClast) for ertugliflozin
Time frame: Up to 7 Days
AUC from Hour 0 to infinity (AUCinf) for ertugliflozin
Time frame: Up to 7 Days
Maximum plasma concentration (Cmax) of ertugliflozin
Time frame: Up to 7 Days
Time taken to reach the maximum observed plasma concentration (Tmax) of ertugliflozin
Time frame: Up to 7 Days
Ertugliflozin half life (t1/2)
Time frame: Up to 7 Days
Amount of Ertugliflozin and metabolites in plasma, urine, and feces
Time frame: Up to 7 Days
Number of Participants Experiencing an Adverse Event (AE)
Time frame: Up to 7 Days
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 23 Mar 2016.
- Derived from this study: PubMed 34213819Fediuk DJ, Sahasrabudhe V, Dawra VK, Zhou S, Sweeney K. Population Pharmacokinetic Analyses of Ertugliflozin in Select Ethnic Populations. Clin Pharmacol Drug Dev. 2021 Nov;10(11):1297-1306. doi: 10.1002/cpdd.970. Epub 2021 Jul 2.
- Derived from this study: PubMed 33813736Marshall JC, Liang Y, Sahasrabudhe V, Tensfeldt T, Fediuk DJ, Zhou S, Krishna R, Dawra VK, Wood LS, Sweeney K. Meta-Analysis of Noncompartmental Pharmacokinetic Parameters of Ertugliflozin to Evaluate Dose Proportionality and UGT1A9 Polymorphism Effect on Exposure. J Clin Pharmacol. 2021 Sep;61(9):1220-1231. doi: 10.1002/jcph.1866. Epub 2021 Jun 19.
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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.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ertugliflozin in people with Type 2 Diabetes Mellitus (T2DM), run by Merck Sharp & Dohme LLC.
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 1 inclusion and 1 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 23 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Mean Percent of Dose Recovered in Urine and Feces Following a Single Oral Dose of [^14C]Ertugliflozin (100 µCi). (time frame: Up to 7 Days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01127308, which also lists 2 linked publications.
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 23 Mar 2016.