Healthy VolunteerPhase 1NCT01018823
A Multiple Dose Study Of Ertugliflozin (PF-04971729, MK-8835) In Otherwise Healthy Overweight And Obese Volunteers (MK-8835-037)
A Phase 1 study testing Ertugliflozin in people with Healthy Volunteer, run by Merck Sharp & Dohme LLC.
Trial summary
Ertugliflozin (PF-04971729, MK-8835) is under development for the treatment of Type 2 Diabetes. The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics, of multiple oral doses of ertugliflozin. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Ertugliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 14 Dec 2009to 18 Mar 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
- 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.
- Body Mass Index (BMI) of 26.5 to 35.5 kg/m2; and a total body weight >50 kg (110 lbs).
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).
- Evidence of glycosuria, as defined by a positive urine dipstick test; Fasting (at least 10 hours) serum triglyceride >300 mg/dL; Fasting (at least 10 hours) LDL-cholesterol >190 mg/dL; Fasting (at least 10 hours) serum 25-OH Vitamin D concentration <20 ng/mL
About this study
Official title: A Phase 1, Randomized, Placebo-Controlled, Parallel Group, 14 Day Repeated Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-04971729 In Otherwise Healthy Overweight And Obese Adult Subjects
Ertugliflozin (PF-04971729, MK-8835) is under development for the treatment of Type 2 Diabetes. The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics, of multiple oral doses of ertugliflozin.
Read the detailed description
To evaluate the safety and tolerability, pharmacokinetics (PK), and pharmacodynamics, of multiple oral doses of ertugliflozin.
- Conditions
- Healthy Volunteer
- Being tested
- Ertugliflozin, Placebo to Ertugliflozin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErtugliflozinDrug
Also called PF-04971729, MK-8835
Ertugliflozin oral dosing 1 mg, 5 mg, 25 mg, or 100 mg solutions/suspensions administered once daily for 14 days immediately after breakfast
Placebo to ErtugliflozinDrug
Placebo oral dosing solutions/suspensions administered once daily for 14 days immediately after breakfast
| Study group | Role | What they receive |
|---|---|---|
| Ertugliflozin 1 mg | Experimental | Ertugliflozin 1 mg, oral, once daily for 14 days Receives: Drug: Ertugliflozin |
| Ertugliflozin up to 5 mg | Experimental | Ertugliflozin up to 5 mg, oral, once daily for 14 days Receives: Drug: Ertugliflozin |
| Ertugliflozin up to 25 mg | Experimental | Ertugliflozin up to 25 mg, oral, once daily for 14 days Receives: Drug: Ertugliflozin |
| Ertugliflozin up to 100 mg | Experimental | Ertugliflozin up to 100 mg, once daily for 14 days Receives: Drug: Ertugliflozin |
| Placebo | Placebo comparator | Placebo to Ertugliflozin once daily for 14 days Receives: Drug: Placebo to Ertugliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing an Adverse Event (AE)
Measured: Up to 28 days postdose (Up to 42 days)
Number of Participants Discontinuing Study Drug Due to an AE
Measured: Up to 14 days
Area under the plasma concentration-time curve (AUC) over the dosing interval tau (AUCtau) for ertugliflozin
Measured: Up to 17 days
Maximum plasma concentration (Cmax) of ertugliflozin
Measured: Up to 17 days
Time taken to reach the maximum observed plasma concentration (Tmax) of ertugliflozin
Measured: Up to 17 days
Ertugliflozin half life (t1/2)
Measured: Up to 17 Days
Apparent clearance (CL/F) after a single dose of ertugliflozin
Measured: Up to 17 days
Apparent volume of distribution (Vz/F)
Measured: Up to 17 days
Observed Accumulation Ratio of Area Under the Curve for the dosing interval of ertugliflozin (Rac[obs])
Measured: Up to 17 days
Change from baseline in 24-hour weighted mean glucose
Measured: Baseline and Day 14
Change from baseline in 24-hour urinary glucose excretion
Measured: Baseline and Day 14
Change from baseline in 24-hour plasma C-peptide
Measured: Baseline and Day 14
Inhibition of glucose reabsorption
Measured: Baseline and Day 14
Change from baseline in body weight
Measured: Baseline and Day 14
Area under the plasma concentration-time curve over 8 hours (AUC[0-8]) for serum intact parathyroid hormone
Measured: Up to 17 days
Area under the plasma concentration-time curve over 24 hours (AUC[0-24]) for serum intact parathyroid hormone
Measured: Up to 17 days
Trough concentration of serum intact parathyroid hormone (Ctrough)
Measured: Up to 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study start14 Dec 2009
- Primary completion18 Mar 2010
- Study completion18 Mar 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 Healthy VolunteerStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 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
- NCT01018823
- Sponsor's protocol ID
- 8835-037
- Status last verified
- May 2020
- First submitted
- 23 Nov 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 32337660Marshall 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 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Placebo-Controlled, Parallel Group, 14 Day Repeated Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-04971729 In Otherwise Healthy Overweight And Obese Adult Subjects
- ClinicalTrials.gov ID
- NCT01018823
- Acronym / sponsor ID
- 8835-037
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- 14 Dec 2009 (actual)
- Primary completion
- 18 Mar 2010 (actual)
- Study completion
- 18 Mar 2010 (actual)
- First posted
- 25 Nov 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.
Ertugliflozin (PF-04971729, MK-8835) is under development for the treatment of Type 2 Diabetes. The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics, of multiple oral doses of ertugliflozin.
Detailed description
To evaluate the safety and tolerability, pharmacokinetics (PK), and pharmacodynamics, of multiple oral doses of ertugliflozin.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Ertugliflozin 1 mg | Experimental | Drug: ErtugliflozinErtugliflozin 1 mg, oral, once daily for 14 days |
| Ertugliflozin up to 5 mg | Experimental | Drug: ErtugliflozinErtugliflozin up to 5 mg, oral, once daily for 14 days |
| Ertugliflozin up to 25 mg | Experimental | Drug: ErtugliflozinErtugliflozin up to 25 mg, oral, once daily for 14 days |
| Ertugliflozin up to 100 mg | Experimental | Drug: ErtugliflozinErtugliflozin up to 100 mg, once daily for 14 days |
| Placebo | Placebo comparator | Drug: Placebo to ErtugliflozinPlacebo to Ertugliflozin once daily for 14 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
- Body Mass Index (BMI) of 26.5 to 35.5 kg/m2; and a total body weight >50 kg (110 lbs).
Key exclusion criteria (2 listed)
- 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).
- Evidence of glycosuria, as defined by a positive urine dipstick test; Fasting (at least 10 hours) serum triglyceride >300 mg/dL; Fasting (at least 10 hours) LDL-cholesterol >190 mg/dL; Fasting (at least 10 hours) serum 25-OH Vitamin D concentration <20 ng/mL
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 |
|---|---|---|
| ErtugliflozinAlso: PF-04971729, MK-8835Ertugliflozin oral dosing 1 mg, 5 mg, 25 mg, or 100 mg solutions/suspensions administered once daily for 14 days immediately after breakfast | Drug | Ertugliflozin 1 mg, Ertugliflozin up to 100 mg, Ertugliflozin up to 25 mg, Ertugliflozin up to 5 mg |
| Placebo to ErtugliflozinPlacebo oral dosing solutions/suspensions administered once daily for 14 days immediately after breakfast | Drug | Placebo |
Primary outcome
Number of Participants Experiencing an Adverse Event (AE)
Time frame: Up to 28 days postdose (Up to 42 days)
Number of Participants Discontinuing Study Drug Due to an AE
Time frame: Up to 14 days
Area under the plasma concentration-time curve (AUC) over the dosing interval tau (AUCtau) for ertugliflozin
Time frame: Up to 17 days
Maximum plasma concentration (Cmax) of ertugliflozin
Time frame: Up to 17 days
Time taken to reach the maximum observed plasma concentration (Tmax) of ertugliflozin
Time frame: Up to 17 days
Ertugliflozin half life (t1/2)
Time frame: Up to 17 Days
Apparent clearance (CL/F) after a single dose of ertugliflozin
Time frame: Up to 17 days
Apparent volume of distribution (Vz/F)
Time frame: Up to 17 days
Observed Accumulation Ratio of Area Under the Curve for the dosing interval of ertugliflozin (Rac[obs])
Time frame: Up to 17 days
Change from baseline in 24-hour weighted mean glucose
Time frame: Baseline and Day 14
Change from baseline in 24-hour urinary glucose excretion
Time frame: Baseline and Day 14
Change from baseline in 24-hour plasma C-peptide
Time frame: Baseline and Day 14
Inhibition of glucose reabsorption
Time frame: Baseline and Day 14
Change from baseline in body weight
Time frame: Baseline and Day 14
Area under the plasma concentration-time curve over 8 hours (AUC[0-8]) for serum intact parathyroid hormone
Time frame: Up to 17 days
Area under the plasma concentration-time curve over 24 hours (AUC[0-24]) for serum intact parathyroid hormone
Time frame: Up to 17 days
Trough concentration of serum intact parathyroid hormone (Ctrough)
Time frame: Up to 17 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 29 May 2020.
- Results publication: PubMed 32337660Fediuk 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.
- 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.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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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 Healthy Volunteer, 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 2 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. Some participants in this study may receive a placebo. 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 28 days postdose (Up to 42 days)). The study lists 17 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 NCT01018823, 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 29 May 2020.