Pharmacokinetics, Safety, and Tolerability of Ertugliflozin (MK-8835/PF-04971729) in Participants With Hepatic Impairment and in Healthy Participants (MK-8835-014)
NCT02115347
ABOUT THIS STUDY
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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
- 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
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
- 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
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Descriptive Information | |||||
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Brief Title ICMJE | Pharmacokinetics, Safety, and Tolerability of Ertugliflozin (MK-8835/PF-04971729) in Participants With Hepatic Impairment and in Healthy Participants (MK-8835-014) | ||||
Official Title ICMJE | 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 | ||||
Brief 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; depending on results in Part 1, Part 2 may be conducted and will enroll participants with mild hepatic impairment (Child-Pugh score 5-6). | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||
Condition ICMJE |
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Intervention ICMJE | Drug: Ertugliflozin 15 mg
Tablet | ||||
Study Arms ICMJE |
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Publications * | 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. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE | 16 | ||||
Original Estimated Enrollment ICMJE | 24 | ||||
Actual Study Completion Date ICMJE | January 19, 2015 | ||||
Actual Primary Completion Date | January 10, 2015 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria: ALL PARTICIPANTS:
Exclusion Criteria: ALL PARTICIPANTS
| ||||
Sex/Gender ICMJE |
| ||||
Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Not Provided | ||||
Removed Location Countries | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT02115347 | ||||
Other Study ID Numbers ICMJE | 8835-014 MK-8835-014 ( Other Identifier: Merck Study number ) B1521024 ( Other Identifier: Pfizer Study number ) | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Merck Sharp & Dohme Corp. | ||||
Study Sponsor ICMJE | Merck Sharp & Dohme Corp. | ||||
Collaborators ICMJE | Pfizer | ||||
Investigators ICMJE |
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PRS Account | Merck Sharp & Dohme Corp. | ||||
Verification Date | August 2018 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |