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Type 2 Diabetes MellitusPhase 1NCT00989079

A Single Escalating Dose Study Of Ertugliflozin (PF-04971729, MK-8835) Under Fed and Fasted Conditons In Healthy Volunteers (MK-8835-036)

A Phase 1 study testing Ertugliflozin in people with Type 2 Diabetes Mellitus, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Ertugliflozin (PF-04971729, MK-8835) is a new compound proposed for the treatment of Type 2 diabetes mellitus. The primary purpose of this study is to evaluate the safety and tolerability along with the pharmacokinetics of single escalating doses of ertugliflozin under fed and fasted conditions in healthy volunteers. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Ertugliflozin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
No sites listed yet
Study dates
16 Oct 2009to 11 Dec 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 of non childbearing potential.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg

Who cannot join

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)

About this study

Official title: A Phase 1 Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of PF-04971729 After Administration of Single Escalating Oral Doses Under Fed and Fasted Conditions in Healthy Volunteers

Ertugliflozin (PF-04971729, MK-8835) is a new compound proposed for the treatment of Type 2 diabetes mellitus. The primary purpose of this study is to evaluate the safety and tolerability along with the pharmacokinetics of single escalating doses of ertugliflozin under fed and fasted conditions in healthy volunteers.

Being tested
Ertugliflozin, Placebo to Ertugliflozin
Keywords
Single Ascending Dose Study in healthy subjects
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 will be administered as an extemporaneously prepared suspension/solution for all doses within the initially planned range.

  • Placebo to ErtugliflozinDrug

    Correspondingly placebo doses to ertugliflozin will be administered as suspension/solution

Study groups in NCT00989079
Study groupRoleWhat they receive
Cohort 1 Sequence 1ExperimentalPeriod 1 (fasted) Placebo → Period 2 (fasted) ertugliflozin (E) 10 mg → Period 3 (fasted) E 100 mg → Period 4 (fed) E 100 mg. Each dose of study drug will be separated by a minimum of 7 days.
Receives: Drug: Ertugliflozin; Drug: Placebo to Ertugliflozin
Cohort 1 Sequence 2ExperimentalPeriod 1 (fasted) E 0.5 mg → Period 2 (fasted) Placebo → Period 3 (fasted) E 100 mg → Period 4 (fed) E 100 mg. Each dose of study drug will be separated by a minimum of 7 days.
Receives: Drug: Ertugliflozin; Drug: Placebo to Ertugliflozin
Cohort 1 Sequence 3ExperimentalPeriod 1 (fasted) E 0.5 mg → Period 2 (fasted) E 10 mg → Period 3 (fasted) Placebo → Period 4 (fed) E 100 mg. Each dose of study drug will be separated by a minimum of 7 days.
Receives: Drug: Ertugliflozin; Drug: Placebo to Ertugliflozin
Cohort 2 Sequence 1ExperimentalPeriod 1 (fasted) Placebo → Period 2 (fasted) E 30 mg → Period 3 (fasted) E 300 mg. Each dose of study drug will be separated by a minimum of 7 days.
Receives: Drug: Ertugliflozin; Drug: Placebo to Ertugliflozin
Cohort 2 Sequence 2ExperimentalPeriod 1 (fasted) E 2.5 mg → Period 2 (fasted) Placebo → Period 3 (fasted) E 300 mg. Each dose of study drug will be separated by a minimum of 7 days.
Receives: Drug: Ertugliflozin; Drug: Placebo to Ertugliflozin
Cohort 2 Sequence 3ExperimentalPeriod 1 (fasted) E 2.5 mg → Period 2 (fasted) E 30 mg → Period 3 (fasted) Placebo. Each dose of study drug will be separated by a minimum of 7 days.
Receives: Drug: Ertugliflozin; Drug: Placebo to Ertugliflozin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Experiencing an Adverse Event (AE)

    Measured: Up to Day 10 of each dosing period

  2. Number of Participants Discontinuing Study Drug Due to an AE

    Measured: Up to Day 8 of each dosing period

  3. Change from baseline in 24-hour urinary glucose excretion

    Measured: Baseline and 24 hours

  4. Area under the plasma concentration-time curve (AUC) from Time 0 to infinity (AUCinf) for ertugliflozin

    Measured: Up to Day 4 of each treatment period

  5. Area under the plasma concentration-time curve (AUC) from Time 0 to time of the last quantifiable concentration (AUClast) for ertugliflozin

    Measured: Up to Day 4 of each treatment period

  6. Maximum plasma concentration (Cmax) of ertugliflozin

    Measured: Up to Day 4 of each treatment period

  7. Time taken to reach the maximum observed plasma concentration (Tmax) of ertugliflozin

    Measured: Up to Day 4 of each treatment period

  8. Ertugliflozin half life (t1/2)

    Measured: Up to Day 4 of each treatment period

  9. Apparent clearance (CL/F) after a single dose of ertugliflozin

    Measured: Up to Day 4 of each treatment period

  10. Apparent volume of distribution (Vz/F)

    Measured: Up to Day 4 of each treatment period

Secondary outcomes (5)

  1. Urinary glucose excretion over 72 hours

    Measured: Up to 72 hours of each dosing period

  2. Change from baseline in 24-hour weighted mean glucose

    Measured: Baseline and 24 hours

  3. Inhibition of glucose reabsorption

    Measured: Up to 24 hours of each dosing period

  4. Renal clearance (CLr) of Ertugliflozin

    Measured: Up to 24 hours of each dosing period

  5. Urinary recovery of Ertugliflozin

    Measured: Up to 24 hours of each dosing period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2009 (estimated)
  2. Study start16 Oct 2009
  3. Primary completion11 Dec 2009
  4. Study completion11 Dec 2009

Resources

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
Other
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00989079
Sponsor's protocol ID
8835-036
Status last verified
May 2020
First submitted
1 Oct 2009
Last updated
29 May 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

  • Fediuk DJ, Nucci G, Dawra VK, Cutler DL, Amin NB, Terra SG, Boyd RA, Krishna R, Sahasrabudhe V. Overview of the Clinical Pharmacology of Ertugliflozin, a Novel Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitor. Clin Pharmacokinet. 2020 Aug;59(8):949-965. doi: 10.1007/s40262-020-00875-1.

    PubMed 32337660

  • 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 34213819

  • Marshall 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

  • Callegari E, Lin J, Tse S, Goosen TC, Sahasrabudhe V. Physiologically-Based Pharmacokinetic Modeling of the Drug-Drug Interaction of the UGT Substrate Ertugliflozin Following Co-Administration with the UGT Inhibitor Mefenamic Acid. CPT Pharmacometrics Syst Pharmacol. 2021 Feb;10(2):127-136. doi: 10.1002/psp4.12581. Epub 2020 Dec 30.

    PubMed 33314761

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ertugliflozin in people with Type 2 Diabetes Mellitus, 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 2 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 29 May 2020. 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?

Number of Participants Experiencing an Adverse Event (AE) (time frame: Up to Day 10 of each dosing period). The study lists 10 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 NCT00989079, which also lists 4 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 29 May 2020.

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