HealthyPhase 1NCT01114568

Study To Estimate The Relative Bioavailability of Ertugliflozin (PF-04971729, MK-8835) in Healthy Adult Participants (MK-8835-039)

A Phase 1 study testing Ertugliflozin 10 mg tablet, Ertugliflozin OC Fast and Ertugliflozin OC Slow in people with Healthy, 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

The purpose of this study is to examine the rate and extent of absorption of three oral formulations of ertugliflozin (PF 04971729, MK-8835) administered in lean to obese healthy volunteers. Read more about this study

Who is it for?: Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Ertugliflozin 10 mg tablet, Ertugliflozin OC Fast and Ertugliflozin OC Slow
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: No sites listed yet
Study dates: May 2010to Jun 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 21 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy male and/or female subjects between the ages of 21 and 65 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests). Women must be of non childbearing potential
Body Mass Index (BMI) of 18.5 to 35.4 kg/m2; and a total body weight >50 kg (110 lbs).
An informed consent document signed and dated by the subject.
Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

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 screening).
Any condition possibly affecting drug absorption (eg, gastrectomy).
A positive urine drug screen at Screening or prior to dosing in Period 1.
History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.

About this study

Official title: A Phase 1, Cross-Over, Single-Dose, Open-Label Study To Estimate The Relative Bioavailability Of Three Different Formulations Of PF-04971729 in Lean To Obese, Otherwise Healthy Adult Subjects

The purpose of this study is to examine the rate and extent of absorption of three oral formulations of ertugliflozin (PF 04971729, MK-8835) administered in lean to obese healthy volunteers.

Conditions: Healthy
Being tested: Ertugliflozin 10 mg tablet, Ertugliflozin OC Fast, Ertugliflozin OC Slow
Keywords: Relative Bioavailability, Pharmacokinetics, Pharmacodynamics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ertugliflozin 10 mg tabletDrug
A single dose of 10 mg ertugliflozin administered as 2x5 mg material sparing formulation tablets.
Ertugliflozin OC FastDrug
Formulation B) Ertugliflozin 10 mg OC Fast
Ertugliflozin OC SlowDrug
Formulation C) Ertugliflozin 10 mg OC Slow

Study groups in NCT01114568
Study group	Role	What they receive
Ertugliflozin 10 mg: tablet→osmotic capsule (OC) fast→OC slow	Experimental	The three treatments are A) a single dose of 10 mg administered as 2x5 mg material sparing formulation tablets B) a single dose of 10 mg extemporaneously prepared osmotic capsule with target release rate of approximately 6 hours (EP-Osmotic Capsule-Fast) and C) a single dose of 10 mg extemporaneously prepared osmotic capsule with target release rate of approximately 14 hours (EP-Osmotic Capsule-Slow). Treatment are administered on Day 1, Hour 0 of each dosing period with a minimum of 7-days wash-out between treatments A, B, and C. Receives: Drug: Ertugliflozin 10 mg tablet; Drug: Ertugliflozin OC Fast; Drug: Ertugliflozin OC Slow
Ertugliflozin 10 mg: tablet→OC slow→OC fast	Experimental	The three treatments are A) a single dose of 10 mg administered as 2x5 mg material sparing formulation tablets B) a single dose of 10 mg EP-Osmotic Capsule-Fast and C) a single dose of 10 mg EP-Osmotic Capsule-Slow. Treatment are administered on Day 1, Hour 0 of each dosing period with a minimum of 7-days wash-out between treatments A, B, and C. Receives: Drug: Ertugliflozin 10 mg tablet; Drug: Ertugliflozin OC Fast; Drug: Ertugliflozin OC Slow
Ertugliflozin 10 mg: OC fast→tablet→OC slow	Experimental	The three treatments are A) a single dose of 10 mg administered as 2x5 mg material sparing formulation tablets B) a single dose of 10 mg EP-Osmotic Capsule-Fast and C) a single dose of 10 mg EP-Osmotic Capsule-Slow. Treatment are administered on Day 1, Hour 0 of each dosing period with a minimum of 7-days wash-out between treatments A, B, and C. Receives: Drug: Ertugliflozin 10 mg tablet; Drug: Ertugliflozin OC Fast; Drug: Ertugliflozin OC Slow
Ertugliflozin 10 mg: OC fast→OC slow→tablet	Experimental	The three treatments are A) a single dose of 10 mg administered as 2x5 mg material sparing formulation tablets B) a single dose of 10 mg EP-Osmotic Capsule-Fast and C) a single dose of 10 mg EP-Osmotic Capsule-Slow. Treatment are administered on Day 1, Hour 0 of each dosing period with a minimum of 7-days wash-out between treatments A, B, and C. Receives: Drug: Ertugliflozin 10 mg tablet; Drug: Ertugliflozin OC Fast; Drug: Ertugliflozin OC Slow
Ertugliflozin 10 mg: OC slow→tablet→OC fast	Experimental	The three treatments are A) a single dose of 10 mg administered as 2x5 mg material sparing formulation tablets B) a single dose of 10 mg EP-Osmotic Capsule-Fast and C) a single dose of 10 mg EP-Osmotic Capsule-Slow. Treatment are administered on Day 1, Hour 0 of each dosing period with a minimum of 7-days wash-out between treatments A, B, and C. Receives: Drug: Ertugliflozin 10 mg tablet; Drug: Ertugliflozin OC Fast; Drug: Ertugliflozin OC Slow
Ertugliflozin 10 mg: OC slow→OC fast→tablet	Experimental	The three treatments are A) a single dose of 10 mg administered as 2x5 mg material sparing formulation tablets B) a single dose of 10 mg EP-Osmotic Capsule-Fast and C) a single dose of 10 mg EP-Osmotic Capsule-Slow. Treatment are administered on Day 1, Hour 0 of each dosing period with a minimum of 7-days wash-out between treatments A, B, and C. Receives: Drug: Ertugliflozin 10 mg tablet; Drug: Ertugliflozin OC Fast; Drug: Ertugliflozin OC Slow

What is being measured

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

Area under the plasma concentration-time curve (AUC) from time 0 to time of the last quantifiable concentration (AUClast) for ertugliflozin
Measured: Up to 48 hr. postdose (Up to Day 3 in each dosing period)
AUC from Hour 0 to infinity (AUCinf) for ertugliflozin
Measured: Up to 48 hr. postdose (Up to Day 3 in each dosing period)
Maximum plasma concentration (Cmax) of ertugliflozin
Measured: Up to 48 hr. postdose (Up to Day 3 in each dosing period)
Time taken to reach the maximum observed plasma concentration (Tmax) of ertugliflozin
Measured: Up to 48 hr. postdose (Up to Day 3 in each dosing period)
Ertugliflozin half life (t1/2)
Measured: Up to 48 hr. postdose (Up to Day 3 in each dosing period)
Number of Participants Experiencing an Adverse Event (AE)
Measured: Up to 28 days postdose (Up to 49 days)
Number of Participants Discontinuing Study Drug Due to an AE
Measured: Up to Day 21
Urinary glucose excretion
Measured: Up to 48 hr. postdose (Up to Day 3 in each dosing period)

Timeline

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

May 2010Jun 2010

First posted3 May 2010 (estimated)
Study startMay 2010
Primary completionJun 2010
Study completionJun 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies 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
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01114568
Sponsor's protocol ID: 8835-039
Status last verified: Mar 2016
First submitted: 27 Apr 2010
Last updated: 17 Mar 2016
Results posted: No
Data monitoring committee: 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

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 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Cross-Over, Single-Dose, Open-Label Study To Estimate The Relative Bioavailability Of Three Different Formulations Of PF-04971729 in Lean To Obese, Otherwise Healthy Adult Subjects
ClinicalTrials.gov ID: NCT01114568
Acronym / sponsor ID: 8835-039
Conditions: Healthy
Keywords: Relative Bioavailability, Pharmacokinetics, Pharmacodynamics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Collaborators: Pfizer
Study start: May 2010
Primary completion: Jun 2010 (actual)
Study completion: Jun 2010 (actual)
First posted: 3 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.

The purpose of this study is to examine the rate and extent of absorption of three oral formulations of ertugliflozin (PF 04971729, MK-8835) administered in lean to obese healthy volunteers.

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Ertugliflozin 10 mg: tablet→osmotic capsule (OC) fast→OC slow	Experimental	Drug: Ertugliflozin 10 mg tablet, Drug: Ertugliflozin OC Fast, Drug: Ertugliflozin OC SlowThe three treatments are A) a single dose of 10 mg administered as 2x5 mg material sparing formulation tablets B) a single dose of 10 mg extemporaneously prepared osmotic capsule with target release rate of approximately 6 hours (EP-Osmotic Capsule-Fast) and C) a single dose of 10 mg extemporaneously prepared osmotic capsule with target release rate of approximately 14 hours (EP-Osmotic Capsule-Slow). Treatment are administered on Day 1, Hour 0 of each dosing period with a minimum of 7-days wash-out between treatments A, B, and C.
Ertugliflozin 10 mg: tablet→OC slow→OC fast	Experimental	Drug: Ertugliflozin 10 mg tablet, Drug: Ertugliflozin OC Fast, Drug: Ertugliflozin OC SlowThe three treatments are A) a single dose of 10 mg administered as 2x5 mg material sparing formulation tablets B) a single dose of 10 mg EP-Osmotic Capsule-Fast and C) a single dose of 10 mg EP-Osmotic Capsule-Slow. Treatment are administered on Day 1, Hour 0 of each dosing period with a minimum of 7-days wash-out between treatments A, B, and C.
Ertugliflozin 10 mg: OC fast→tablet→OC slow	Experimental	Drug: Ertugliflozin 10 mg tablet, Drug: Ertugliflozin OC Fast, Drug: Ertugliflozin OC SlowThe three treatments are A) a single dose of 10 mg administered as 2x5 mg material sparing formulation tablets B) a single dose of 10 mg EP-Osmotic Capsule-Fast and C) a single dose of 10 mg EP-Osmotic Capsule-Slow. Treatment are administered on Day 1, Hour 0 of each dosing period with a minimum of 7-days wash-out between treatments A, B, and C.
Ertugliflozin 10 mg: OC fast→OC slow→tablet	Experimental	Drug: Ertugliflozin 10 mg tablet, Drug: Ertugliflozin OC Fast, Drug: Ertugliflozin OC SlowThe three treatments are A) a single dose of 10 mg administered as 2x5 mg material sparing formulation tablets B) a single dose of 10 mg EP-Osmotic Capsule-Fast and C) a single dose of 10 mg EP-Osmotic Capsule-Slow. Treatment are administered on Day 1, Hour 0 of each dosing period with a minimum of 7-days wash-out between treatments A, B, and C.
Ertugliflozin 10 mg: OC slow→tablet→OC fast	Experimental	Drug: Ertugliflozin 10 mg tablet, Drug: Ertugliflozin OC Fast, Drug: Ertugliflozin OC SlowThe three treatments are A) a single dose of 10 mg administered as 2x5 mg material sparing formulation tablets B) a single dose of 10 mg EP-Osmotic Capsule-Fast and C) a single dose of 10 mg EP-Osmotic Capsule-Slow. Treatment are administered on Day 1, Hour 0 of each dosing period with a minimum of 7-days wash-out between treatments A, B, and C.
Ertugliflozin 10 mg: OC slow→OC fast→tablet	Experimental	Drug: Ertugliflozin 10 mg tablet, Drug: Ertugliflozin OC Fast, Drug: Ertugliflozin OC SlowThe three treatments are A) a single dose of 10 mg administered as 2x5 mg material sparing formulation tablets B) a single dose of 10 mg EP-Osmotic Capsule-Fast and C) a single dose of 10 mg EP-Osmotic Capsule-Slow. Treatment are administered on Day 1, Hour 0 of each dosing period with a minimum of 7-days wash-out between treatments A, B, and C.

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Healthy male and/or female subjects between the ages of 21 and 65 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests). Women must be of non childbearing potential
Body Mass Index (BMI) of 18.5 to 35.4 kg/m2; and a total body weight >50 kg (110 lbs).
An informed consent document signed and dated by the subject.
Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Key exclusion criteria (4 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 screening).
Any condition possibly affecting drug absorption (eg, gastrectomy).
A positive urine drug screen at Screening or prior to dosing in Period 1.
History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of 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
Ertugliflozin 10 mg tabletA single dose of 10 mg ertugliflozin administered as 2x5 mg material sparing formulation tablets.	Drug	Ertugliflozin 10 mg: OC fast→OC slow→tablet, Ertugliflozin 10 mg: OC fast→tablet→OC slow, Ertugliflozin 10 mg: OC slow→OC fast→tablet, Ertugliflozin 10 mg: OC slow→tablet→OC fast, Ertugliflozin 10 mg: tablet→OC slow→OC fast, Ertugliflozin 10 mg: tablet→osmotic capsule (OC) fast→OC slow
Ertugliflozin OC FastFormulation B) Ertugliflozin 10 mg OC Fast	Drug	Ertugliflozin 10 mg: OC fast→OC slow→tablet, Ertugliflozin 10 mg: OC fast→tablet→OC slow, Ertugliflozin 10 mg: OC slow→OC fast→tablet, Ertugliflozin 10 mg: OC slow→tablet→OC fast, Ertugliflozin 10 mg: tablet→OC slow→OC fast, Ertugliflozin 10 mg: tablet→osmotic capsule (OC) fast→OC slow
Ertugliflozin OC SlowFormulation C) Ertugliflozin 10 mg OC Slow	Drug	Ertugliflozin 10 mg: OC fast→OC slow→tablet, Ertugliflozin 10 mg: OC fast→tablet→OC slow, Ertugliflozin 10 mg: OC slow→OC fast→tablet, Ertugliflozin 10 mg: OC slow→tablet→OC fast, Ertugliflozin 10 mg: tablet→OC slow→OC fast, Ertugliflozin 10 mg: tablet→osmotic capsule (OC) fast→OC slow

Primary outcome

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 48 hr. postdose (Up to Day 3 in each dosing period)
AUC from Hour 0 to infinity (AUCinf) for ertugliflozin
Time frame: Up to 48 hr. postdose (Up to Day 3 in each dosing period)
Maximum plasma concentration (Cmax) of ertugliflozin
Time frame: Up to 48 hr. postdose (Up to Day 3 in each dosing period)
Time taken to reach the maximum observed plasma concentration (Tmax) of ertugliflozin
Time frame: Up to 48 hr. postdose (Up to Day 3 in each dosing period)
Ertugliflozin half life (t1/2)
Time frame: Up to 48 hr. postdose (Up to Day 3 in each dosing period)
Number of Participants Experiencing an Adverse Event (AE)
Time frame: Up to 28 days postdose (Up to 49 days)
Number of Participants Discontinuing Study Drug Due to an AE
Time frame: Up to Day 21
Urinary glucose excretion
Time frame: Up to 48 hr. postdose (Up to Day 3 in each dosing period)

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 17 Mar 2016.
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 10 mg tablet, Ertugliflozin OC Fast and Ertugliflozin OC Slow in people with Healthy, 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 4 inclusion and 4 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 17 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?

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 48 hr. postdose (Up to Day 3 in each dosing period)). 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 NCT01114568, which also lists 1 linked publication.

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 17 Mar 2016.