- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01407276
A Study of Omarigliptin (MK-3102) in Participants With Impaired Renal Function (MK-3102-009)
August 8, 2018 updated by: Merck Sharp & Dohme LLC
An Open-Label, Two-Part, Single-Dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of MK-3102 in Patients With Impaired Renal Function
This is a 2-part study in participants with renal impairment and matched healthy participants to investigate the effect of impaired renal function on the plasma and urine levels of omarigliptin (MK-3102) after taking a single 3 mg dose by mouth.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
In Part I, three panels of 6 participants each will be enrolled with varying degrees of renal disease (mild, moderate, or severe renal impairment) based on their estimated glomerular filtration rate (eGFR).
Each of these panels will be matched with a corresponding panel of equal number of healthy, age-, race-, BMI- and gender-matched control participants.
All panels will receive a single oral dose of 3-mg omarigliptin, followed by plasma sampling and urine collection.
In Part II, 6 participants with end stage renal disease (ESRD) requiring hemodialysis will receive a single 3-mg oral dose of omarigliptin immediately following hemodialysis (HD) (Period 1) and 2 hours prior to HD (Period 2).There will be approximately 1 month between Period 1 and Period 2. A corresponding panel of equal number, healthy matched control subjects (age, race, BMI, gender) will also receive a single 3 mg dose by mouth.
Omarigliptin dose administration will be followed by plasma sampling for both panels.
Study Type
Interventional
Enrollment (Actual)
49
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
Impaired Renal Function Subjects:
- Females of reproductive potential must have a negative pregnancy test and agree to use 2 methods of birth control
- Diagnosis of renal insufficiency based on estimated glomerular filtration rate (eGFR) calculated using the Modification of Diet in Renal Disease (MDRD) equation
Healthy Subjects:
- Females of reproductive potential must have a negative pregnancy test and agree to use 2 methods of birth control;
- In general good health
Exclusion Criteria:
Impaired Renal Function Subjects:
- Is mentally or legally incapacitated
- Has rapidly fluctuating renal function or has demonstrated or suspected renal artery stenosis
- History of significant endocrine (other than Type 2 diabetes), gastrointestinal, cardiovascular, hematological, immunological, respiratory, or genitourinary diseases
- History of stroke, chronic seizures or major neurological disease
- Uncontrolled Type 2 diabetes or history of Type 1 diabetes or ketoacidosis
- History of cancer (Some exceptions apply)
- Regular user of barbiturates or sleep aides
- Consumes excessive amounts of alcohol (more than 2 drinks/day)
- Consumes excessive amounts of caffeinated beverages (more than 6/day)
- Has had major surgery or has lost or donated 1 unit of blood within 4 weeks
- Has a history of significant multiple and/or severe allergies
- Current or history of illicit drug abuse
- Nursing mothers
Healthy Subjects:
- Is mentally or legally incapacitated;
- Has a history of stroke, chronic seizures, or major neurological disorder
- Renal impairment
- History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, immunological, respiratory, or genitourinary diseases
- Hypoglycemia, glucose intolerance, Type 1 or Type 2 diabetes, or ketoacidosis
- History of cancer (Some exceptions apply)
- Regular user of barbiturates or sleep aides
- Consumes excessive amounts of alcohol (more than 2 drinks/day)
- Consumes excessive amounts of caffeinated beverages (more than 6/day)
- Has had major surgery or has lost or donated 1 unit of blood within 4 weeks
- Has a history of significant multiple and/or severe allergies
- Current or history of illicit drug abuse
- Nursing mothers
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Part 1: Mild Renal Impairment (Panel A)
|
Single oral dose of 3 mg (3 x 1-mg capsules)
Other Names:
|
Experimental: Part 1: Control to Match Panel A (Panel B)
|
Single oral dose of 3 mg (3 x 1-mg capsules)
Other Names:
|
Experimental: Part 1: Moderate Renal Impairment (Panel C)
|
Single oral dose of 3 mg (3 x 1-mg capsules)
Other Names:
|
Experimental: Part 1: Control to Match Panel C (Panel D)
|
Single oral dose of 3 mg (3 x 1-mg capsules)
Other Names:
|
Experimental: Part 1: Severe Renal Impairment (Panel E)
|
Single oral dose of 3 mg (3 x 1-mg capsules)
Other Names:
|
Experimental: Part 1: Control to Match Panel E (Panel F)
|
Single oral dose of 3 mg (3 x 1-mg capsules)
Other Names:
|
Experimental: Part 2: End-stage Renal Disease needing hemodialysis (Panel G)
|
Single oral dose of 3 mg (3 x 1-mg capsules)
Other Names:
|
Experimental: Part 2: Control to Match Panel G (Panel H)
|
Single oral dose of 3 mg (3 x 1-mg capsules)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) of Omarigliptin
Time Frame: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, 168, 240, and 336 hours post-dose
|
AUC0-∞ is a measure of the mean concentration levels of drug in the plasma after the dose.
|
Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, 168, 240, and 336 hours post-dose
|
Maximum Concentration (Cmax) of Omarigliptin
Time Frame: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, 168, 240, and 336 hours post-dose
|
Cmax is a measure of the maximum amount of drug in the plasma after the dose is given.
|
Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, 168, 240, and 336 hours post-dose
|
Area Under the Concentration-time Curve From Time 0 to 168 Hours Post Dose (AUC0-168h) of Omarigliptin
Time Frame: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, and 168 hours post-dose
|
AUC0-168h is a measure of the total amount of drug in the plasma from the dose to 168 hours after the dose.
|
Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, and 168 hours post-dose
|
Concentration at 168 Hours Post-dose (C168h) of Omarigliptin
Time Frame: 168 hours post-dose
|
C168h is a measure of the plasma drug concentration 168 hours post-dose.
|
168 hours post-dose
|
Apparent Volume of Distribution (Vd/F) of Omarigliptin
Time Frame: Up to 336 hours post-dose
|
Vd/F is defined as the distribution of a medication between the plasma and the rest of the body after the dose.
It is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of the drug.
|
Up to 336 hours post-dose
|
Apparent Total Body Clearance (CL/F) of Omarigliptin
Time Frame: Up to 336 hours post-dose
|
CL/F is a calculation of the rate at which a drug is removed from the body via renal, hepatic, and other clearance pathways, expressed as volume (milliliters) per unit of time (minutes).
|
Up to 336 hours post-dose
|
Renal Clearance (CLr) of Omarigliptin
Time Frame: Up to 336 hours post-dose
|
CLr is a calculation of the rate at which a drug is removed from the body via renal clearance pathways, expressed as volume (milliliters) per unit of time (minutes).
CLr was only determined for Panels A-F.
|
Up to 336 hours post-dose
|
Fraction of Dose Excreted Unchanged in Urine Through 48 Hours Post-dose (fe48h) of Omarigliptin
Time Frame: Up to 48 hours post-dose
|
fe48h is expressed as percentage of omarigliptin not metabolized and excreted in urine.
fe48h was only determined for Panels A-F.
|
Up to 48 hours post-dose
|
Cumulative Amount of Drug Excreted in Urine Over 48 Hours (Ae0-48h) of Omarigliptin
Time Frame: Up to 48 hours post-dose
|
Ae0-48h is a measure of the cumulative amount of drug excreted in the urine for 48 hours post-dose.
Ae0-48h was only determined for Panels A-F.
|
Up to 48 hours post-dose
|
Time to Maximum Concentration (Tmax) of Omarigliptin
Time Frame: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, 168, 240, and 336 hours post-dose
|
Tmax is a measure of the time to reach the maximum drug plasma concentration post-dose.
|
Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, 168, 240, and 336 hours post-dose
|
Apparent Terminal Half-life (t1/2) of Omarigliptin
Time Frame: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, 168, 240, and 336 hours post-dose
|
T1/2 is the time required for the maximum concentration of a drug in the plasma to decrease by 50%.
|
Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, 168, 240, and 336 hours post-dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Experiencing an Adverse Event (AE)
Time Frame: From pre-dose to 14 days post-dose (Up to Day 15)
|
An AE was defined as any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.
|
From pre-dose to 14 days post-dose (Up to Day 15)
|
Number of Participants Withdrawn From Study
Time Frame: Up to Day 15
|
Up to Day 15
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 8, 2011
Primary Completion (Actual)
March 23, 2012
Study Completion (Actual)
March 23, 2012
Study Registration Dates
First Submitted
July 29, 2011
First Submitted That Met QC Criteria
July 29, 2011
First Posted (Estimate)
August 2, 2011
Study Record Updates
Last Update Posted (Actual)
September 10, 2018
Last Update Submitted That Met QC Criteria
August 8, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3102-009
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Study Data/Documents
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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