Type 2 Diabetes MellitusPhase 1NCT02115347

Pharmacokinetics, Safety, and Tolerability of Ertugliflozin (MK-8835/PF-04971729) in Participants With Hepatic Impairment and in Healthy Participants (MK-8835-014)

A Phase 1 study testing Ertugliflozin 15 mg in people with Type 2 Diabetes Mellitus and Hepatic Impairment, 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

This is a study to assess the pharmacokinetics and safety of ertugliflozin (MK-8835, PF-04971729) in participants with hepatic impairment versus healthy participants. In Part 1 of the study, participants with moderate hepatic impairment (Child-Pugh score 7-9) and matched healthy participants will be enrolled… Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Type 2 Diabetes Mellitus, Hepatic Impairment
What is being tested?: Ertugliflozin 15 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: No sites listed yet
Study dates: 19 Sep 2014to 19 Jan 2015
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

ALL PARTICIPANTS:
Body Mass Index (BMI) of 18 to 40 kg/m^2; and a total body weight >50 kg (110 lbs)
Male or female not of reproductive potential
If a female of reproductive potential, agrees to remain abstinent from heterosexual activity or agree to use or have their partner use 2 methods of acceptable contraception to prevent pregnancy while the participant is receiving study medication and for 14 days after the last dose of study medication PARTICIPANTS WITH NORMAL HEPATIC FUNCTION
Healthy with normal hepatic function PARTICIPANTS WITH HEPATIC IMPAIRMENT
Satisfy the criteria for Child-Pugh classification [moderate (Part 1): Child-Pugh Scores 7-9 points, mild (Part 2): Child-Pugh Scores 5-6 points] within 14 days before administration of study medication

Show all 9Show fewer

A diagnosis of hepatic impairment due to primary liver disease and not secondary to other diseases
Stable hepatic impairment, defined as no clinically-significant change in disease status within the last 30 days
On a stable dose of medication and/or treatment regimen used to manage hepatic disease for at least 4 weeks prior to study start

Who cannot join

ALL PARTICIPANTS
A known hypersensitivity or intolerance to ertugliflozin or any other Sodium-Glucose co-Transporter 2 (SGLT2) inhibitor (i.e., canagliflozin [Invokana], dapagliflozin [Farxiga], empagliflozin, or ipragliflozin)
Febrile illness within 5 days prior to the first dose of study medication
Any clinically significant malabsorption condition
A positive urine drug screen for drugs of abuse or recreational drugs
Abuse of alcohol or binge drinking and/or any other illicit drug use or dependence within 6 months of study start

Show all 20Show fewer

Treatment with an investigational drug within 30 days preceding the first dose of study medication
Pregnant or breastfeeding females
Use of herbal supplements within 28 days prior to the first dose of study medication
Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to dosing
History of sensitivity to heparin or heparin-induced thrombocytopenia PARTICIPANTS WITH NORMAL HEPATIC FUNCTION
Use of prescription drugs (hormonal methods of birth control are allowed), vitamins, and dietary supplements within 7 days prior to the first dose of study medication
Positive serology for Hepatitis B or C PARTICIPANTS WITH HEPATIC IMPAIRMENT
Hepatic carcinoma and hepatorenal syndrome or life expectancy less than 1 year
Undergone portal-caval shunt surgery
History of gastrointestinal hemorrhage due to esophageal varices or peptic ulcers less than 1 month prior to study entry
Signs of significant hepatic encephalopathy
Severe ascites and/or pleural effusion
A transplanted kidney, heart or liver
Received any of the following medications within 7 days prior to the first dose of study medication or during the study: other SGLT2 inhibitors (eg, dapagliflozin, canagliflozin, empagliflozin, and ipragliflozin); any potent drug-metabolizing enzyme-inducing drug, including rifampin, phenytoin, and carbamazepine; probenecid, valproic acid, gemfibrozil

About this study

Official title: A Phase 1, Non-randomized, Open-label, Single Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Ertugliflozin (MK-8835/PF-04971729) in Subjects With Hepatic Impairment and the Healthy Subjects With Normal Hepatic Function

Conditions: Type 2 Diabetes Mellitus, Hepatic Impairment
Being tested: Ertugliflozin 15 mg
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.

Ertugliflozin 15 mgDrug
Tablet

Study groups in NCT02115347
Study group	Role	What they receive
Ertugliflozin 15 mg - Moderate Hepatic Impairment	Experimental	Participants receive a single 15 mg oral dose (tablet) of ertugliflozin Receives: Drug: Ertugliflozin 15 mg
Ertugliflozin 15 mg - Healthy Participants	Other	Participants receive a single 15 mg oral dose (tablet) of ertugliflozin Receives: Drug: Ertugliflozin 15 mg
Ertugliflozin 15 mg - Mild Hepatic Impairment	Experimental	Participants receive a single 15 mg oral dose (tablet) of ertugliflozin Receives: Drug: Ertugliflozin 15 mg

What is being measured

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

Area Under the Plasma Concentration-Time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUClast) for Ertugliflozin
Area under the plasma concentration-time profile from time zero to time of the last quantifiable concentration (AUClast).
Measured: Hour 0 (predose), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours
AUC From Hour 0 to Infinity (AUCinf) for Ertugliflozin
Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf).
Measured: Hour 0 (predose), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours

Secondary outcomes (5)

AUClast for Fraction of Ertugliflozin Unbound in Plasma (AUClast,u)
Area under the plasma concentration-time profile from time zero to time of the last quantifiable concentration (Clast) for unbound drug (ertugliflozin only).
Measured: Hour 0 (predose), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours
AUCinf for Fraction of Ertugliflozin Unbound in Plasma (AUCinf,u)
Area under the plasma concentration-time profile from time zero extrapolated to infinite time for unbound drug (ertugliflozin only) (AUCinf, u).
Measured: Hour 0 (predose), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours
Maximum Plasma Concentration (Cmax) of Ertugliflozin
Cmax is a measure of the maximum amount of drug in the plasma after the dose is given.
Measured: Hour 0 (predose), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours
Cmax for Fraction of Ertugliflozin Unbound in Plasma (Cmax,u)
Maximum plasma concentration for unbound drug (ertugliflozin only).
Measured: Hour 0 (predose), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours
Number of Participants Who Experienced an Adverse Event
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Measured: Up to 19 days

Timeline

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

19 Sep 201419 Jan 2015

First posted16 Apr 2014 (estimated)
Study start19 Sep 2014
Primary completion10 Jan 2015
Study completion19 Jan 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Type 2 Diabetes MellitusStudies 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: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02115347
Sponsor's protocol ID: 8835-014
Other IDs: MK-8835-014, B1521024
Status last verified: Aug 2018
First submitted: 14 Apr 2014
Last updated: 20 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

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
Sahasrabudhe V, Terra SG, Hickman A, Saur D, Raje S, Shi H, Matschke K, Zhou S, Cutler DL. Pharmacokinetics of Single-dose Ertugliflozin in Patients With Hepatic Impairment. Clin Ther. 2018 Oct;40(10):1701-1710. doi: 10.1016/j.clinthera.2018.06.015. Epub 2018 Sep 14.
PubMed 30224193

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Non-randomized, Open-label, Single Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Ertugliflozin (MK-8835/PF-04971729) in Subjects With Hepatic Impairment and the Healthy Subjects With Normal Hepatic Function
ClinicalTrials.gov ID: NCT02115347
Acronym / sponsor ID: 8835-014
Conditions: Type 2 Diabetes Mellitus, Hepatic Impairment
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Collaborators: Pfizer
Study start: 19 Sep 2014 (actual)
Primary completion: 10 Jan 2015 (actual)
Study completion: 19 Jan 2015 (actual)
First posted: 16 Apr 2014 (estimated)
Results: Posted 3 Aug 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Ertugliflozin 15 mg - Moderate Hepatic Impairment	Experimental	Drug: Ertugliflozin 15 mgParticipants receive a single 15 mg oral dose (tablet) of ertugliflozin
Ertugliflozin 15 mg - Healthy Participants	Other	Drug: Ertugliflozin 15 mgParticipants receive a single 15 mg oral dose (tablet) of ertugliflozin
Ertugliflozin 15 mg - Mild Hepatic Impairment	Experimental	Drug: Ertugliflozin 15 mgParticipants receive a single 15 mg oral dose (tablet) of ertugliflozin

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Body Mass Index (BMI) of 18 to 40 kg/m^2; and a total body weight >50 kg (110 lbs)
Male or female not of reproductive potential
If a female of reproductive potential, agrees to remain abstinent from heterosexual activity or agree to use or have their partner use 2 methods of acceptable contraception to prevent pregnancy while the participant is receiving study medication and for 14 days after the last dose of study medication PARTICIPANTS WITH NORMAL HEPATIC FUNCTION
Healthy with normal hepatic function PARTICIPANTS WITH HEPATIC IMPAIRMENT
Satisfy the criteria for Child-Pugh classification [moderate (Part 1): Child-Pugh Scores 7-9 points, mild (Part 2): Child-Pugh Scores 5-6 points] within 14 days before administration of study medication

Key exclusion criteria (20 listed)

ALL PARTICIPANTS
A known hypersensitivity or intolerance to ertugliflozin or any other Sodium-Glucose co-Transporter 2 (SGLT2) inhibitor (i.e., canagliflozin [Invokana], dapagliflozin [Farxiga], empagliflozin, or ipragliflozin)
Febrile illness within 5 days prior to the first dose of study medication
Any clinically significant malabsorption condition
A positive urine drug screen for drugs of abuse or recreational drugs

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
Ertugliflozin 15 mgTablet	Drug	Ertugliflozin 15 mg - Healthy Participants, Ertugliflozin 15 mg - Mild Hepatic Impairment, Ertugliflozin 15 mg - Moderate Hepatic Impairment

Primary outcome

Area Under the Plasma Concentration-Time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUClast) for Ertugliflozin
Time frame: Hour 0 (predose), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours
Area under the plasma concentration-time profile from time zero to time of the last quantifiable concentration (AUClast).
AUC From Hour 0 to Infinity (AUCinf) for Ertugliflozin
Time frame: Hour 0 (predose), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours
Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf).

5 secondary outcomes

AUClast for Fraction of Ertugliflozin Unbound in Plasma (AUClast,u)
Time frame: Hour 0 (predose), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours
AUCinf for Fraction of Ertugliflozin Unbound in Plasma (AUCinf,u)
Time frame: Hour 0 (predose), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours
Maximum Plasma Concentration (Cmax) of Ertugliflozin
Time frame: Hour 0 (predose), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours
Cmax for Fraction of Ertugliflozin Unbound in Plasma (Cmax,u)
Time frame: Hour 0 (predose), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours
Number of Participants Who Experienced an Adverse Event
Time frame: Up to 19 days

Results and safety

Results posted to the registry on 3 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ertugliflozin 15 mg (Moderate Hepatic Impairment)	8	8
Ertugliflozin 15 mg (Normal Hepatic Function)	8	8
Ertugliflozin 15 mg - Mild Hepatic Impairment	0	0

Primary outcome: Area Under the Plasma Concentration-Time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUClast) for Ertugliflozin

Time frame: Hour 0 (predose), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours. Geometric mean (Geometric Coefficient of Variation). Unit: ng•hr/mL

Measure	Ertugliflozin 15 mg (Moderate Hepatic Impairment) n = 8	Ertugliflozin 15 mg (Normal Hepatic Function) n = 8
Value	1413 (39)	1618 (14)

Ertugliflozin 15 mg (Moderate Hepatic Impairment) vs Ertugliflozin 15 mg (Normal Hepatic Function): Ratio (Test/Reference) of Adjusted Means: 87.31 (90% CI 68.01 to 112.08)

Population analysed: The analysis population was all treated participants who had at least 1 measurement of the AUClast parameter. Based on a statistical evaluation of the PK data from participants with moderate hepatic impairment and matched healthy volunteers, Part 2 of the study was not conducted and participants with mild hepatic impairment were not enrolled.

Primary outcome: AUC From Hour 0 to Infinity (AUCinf) for Ertugliflozin

Time frame: Hour 0 (predose), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours. Geometric mean (Geometric Coefficient of Variation). Unit: ng•hr/mL

Measure	Ertugliflozin 15 mg (Moderate Hepatic Impairment) n = 8	Ertugliflozin 15 mg (Normal Hepatic Function) n = 8
Value	1430 (39)	1636 (14)

Ertugliflozin 15 mg (Moderate Hepatic Impairment) vs Ertugliflozin 15 mg (Normal Hepatic Function): Ratio (Test/Reference) of Adjusted Means: 87.43 (90% CI 68.11 to 112.22)

Population analysed: The analysis population was all treated participants who had at least 1 measurement of the AUCinf parameter. Based on a statistical evaluation of the PK data from participants with moderate hepatic impairment and matched healthy volunteers, Part 2 of the study was not conducted and participants with mild hepatic impairment were not enrolled.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Day 19. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ertugliflozin 15 mg (Moderate Hepatic Impairment)	0 of 8 (0%)	2 of 8 (25%)	Not reported
Ertugliflozin 15 mg (Normal Hepatic Function)	0 of 8 (0%)	3 of 8 (37.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Derived from this study: PubMed 30224193Sahasrabudhe V, Terra SG, Hickman A, Saur D, Raje S, Shi H, Matschke K, Zhou S, Cutler DL. Pharmacokinetics of Single-dose Ertugliflozin in Patients With Hepatic Impairment. Clin Ther. 2018 Oct;40(10):1701-1710. doi: 10.1016/j.clinthera.2018.06.015. Epub 2018 Sep 14.

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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/Pfizer

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ertugliflozin 15 mg in people with Type 2 Diabetes Mellitus and Hepatic Impairment, 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 9 inclusion and 20 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 20 Aug 2018. 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?

Yes. Results are posted in the registry (first posted 3 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Area Under the Plasma Concentration-Time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUClast) for Ertugliflozin (time frame: Hour 0 (predose), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours). The study lists 2 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 NCT02115347, 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 20 Aug 2018.