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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01407276
Other study ID # 3102-009
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date August 8, 2011
Est. completion date March 23, 2012

Study information

Verified date August 2018
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 49
Est. completion date March 23, 2012
Est. primary completion date March 23, 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Intervention

Drug:
Omarigliptin
Single oral dose of 3 mg (3 x 1-mg capsules)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type Measure Description Time frame Safety issue
Primary Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-8) of Omarigliptin AUC0-8 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
Primary Maximum Concentration (Cmax) of Omarigliptin 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
Primary Area Under the Concentration-time Curve From Time 0 to 168 Hours Post Dose (AUC0-168h) of Omarigliptin 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
Primary Concentration at 168 Hours Post-dose (C168h) of Omarigliptin C168h is a measure of the plasma drug concentration 168 hours post-dose. 168 hours post-dose
Primary Apparent Volume of Distribution (Vd/F) of Omarigliptin 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
Primary Apparent Total Body Clearance (CL/F) of Omarigliptin 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
Primary Renal Clearance (CLr) of Omarigliptin 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
Primary Fraction of Dose Excreted Unchanged in Urine Through 48 Hours Post-dose (fe48h) of Omarigliptin 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
Primary Cumulative Amount of Drug Excreted in Urine Over 48 Hours (Ae0-48h) of Omarigliptin 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
Primary Time to Maximum Concentration (Tmax) of Omarigliptin 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
Primary Apparent Terminal Half-life (t1/2) of Omarigliptin 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 Number of Participants Experiencing an Adverse Event (AE) 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)
Secondary Number of Participants Withdrawn From Study Up to Day 15
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