A Study of Omarigliptin (MK-3102) in Participants With Im... | NCT01407276 | Trialant
NCT01407276
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Sep 10, 2018Actual
Enrollment
49Actual
Phase
Phase 1
Conditions
Chronic Renal Insufficiency
Type 2 Diabetes Mellitus
Interventions
Omarigliptin
Countries
Not provided
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT01407276
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
3102-009
Secondary IDs
Not provided
Brief Title
A Study of Omarigliptin (MK-3102) in Participants With Impaired Renal Function (MK-3102-009)
Official Title
An Open-Label, Two-Part, Single-Dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of MK-3102 in Patients With Impaired Renal Function
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Aug 2018
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 8, 2011Actual
Primary Completion Date
Mar 23, 2012Actual
Completion Date
Mar 23, 2012Actual
First Submitted Date
Jul 29, 2011
First Submission Date that Met QC Criteria
Jul 29, 2011
First Posted Date
Aug 2, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 29, 2015
Results First Submitted that Met QC Criteria
Oct 30, 2015
Results First Posted Date
Dec 3, 2015Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Aug 8, 2018
Last Update Posted Date
Sep 10, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief 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.
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.
Conditions Module
Conditions
Chronic Renal Insufficiency
Type 2 Diabetes Mellitus
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
49Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1: Mild Renal Impairment (Panel A)
Experimental
Drug: Omarigliptin
Part 1: Control to Match Panel A (Panel B)
Experimental
Drug: Omarigliptin
Part 1: Moderate Renal Impairment (Panel C)
Experimental
Drug: Omarigliptin
Part 1: Control to Match Panel C (Panel D)
Experimental
Drug: Omarigliptin
Part 1: Severe Renal Impairment (Panel E)
Experimental
Drug: Omarigliptin
Part 1: Control to Match Panel E (Panel F)
Experimental
Drug: Omarigliptin
Part 2: End-stage Renal Disease needing hemodialysis (Panel G)
Experimental
Drug: Omarigliptin
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Omarigliptin
Drug
Single oral dose of 3 mg (3 x 1-mg capsules)
Part 1: Control to Match Panel A (Panel B)
Part 1: Control to Match Panel C (Panel D)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) of Omarigliptin
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
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
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
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
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
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).
Secondary Outcomes
Measure
Description
Time Frame
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)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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
One healthy matched control participant withdrew consent for study participation on Day 15; this participant was replaced. Thus, a total of 49 participants were in the study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1: Mild Renal Impairment (Panel A)
Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
FG001
Part 1: Control to Match Panel A (Panel B)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
FG002
Part 1: Moderate Renal Impairment (Panel C)
Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
FG003
Part 1: Control to Match Panel C (Panel D)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
FG004
Part 1: Severe Renal Impairment (Panel E)
Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
FG005
Part 1: Control to Match Panel E (Panel F)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
FG006
Part 2: ESRD Requiring HD (Panel G)
Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD)
FG007
Part 2: Control to Match Panel G (Panel H)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel G.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG0006 subjects
FG0016 subjects
FG0026 subjects
FG0036 subjects
FG0046 subjects
FG0056 subjects
FG0066 subjects
FG0077 subjects
COMPLETED
FG0006 subjects
FG0016 subjects
FG0026 subjects
FG0036 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1: Mild Renal Impairment (Panel A)
Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
BG001
Part 1: Control to Match Panel A (Panel B)
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) of Omarigliptin
AUC0-∞ is a measure of the mean concentration levels of drug in the plasma after the dose.
All participants that received a single 3 mg dose of omarigliptin.
Posted
Geometric Mean
95% Confidence Interval
nM*hr
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
ID
Title
Description
OG000
Part 1: Mild Renal Impairment (Panel A)
Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
OG001
Part 1: Control to Match Panel A (Panel B)
Adverse Events Module
Frequency Threshold
5
Time Frame
From pre-dose to 14 days post-dose (up to Day 15)
Description
An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part 1: Mild Renal Impairment (Panel A)
Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
Serious Adverse Events
Not provided
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Laryngitis
Infections and infestations
MedDRA v.15.0
Systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Part 2: End-stage Renal Disease needing hemodialysis (Panel G)
MK-3102
Up to 336 hours post-dose
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
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
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
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
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
Number of Participants Withdrawn From Study
Up to Day 15
6 subjects
FG0056 subjects
FG0066 subjects
FG0076 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
BG002
Part 1: Moderate Renal Impairment (Panel C)
Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
BG003
Part 1: Control to Match Panel C (Panel D)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
BG004
Part 1: Severe Renal Impairment (Panel E)
Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
BG005
Part 1: Control to Match Panel E (Panel F)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
BG006
Part 2: ESRD Requiring HD (Panel G)
Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD)
BG007
Part 2: Control to Match Panel G (Panel H)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel G.
BG008
Total
Total of all reporting groups
6
BG0016
BG0026
BG0036
BG0046
BG0056
BG0066
BG0077
BG00849
Full Range
Years
Title
Denominators
Categories
Title
Measurements
BG00071(67 to 75)
BG00168(64 to 74)
BG00262(50 to 74)
BG00360(51 to 74)
BG00464(54 to 72)
BG00560(51 to 69)
BG00646(36 to 60)
BG00743(33 to 57)
BG00859(33 to 75)
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0004
BG0014
BG0022
BG0032
BG0042
BG0052
BG0062
BG0073
BG00821
Male
BG0002
BG0012
BG0024
BG0034
BG004
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
OG002
Part 1: Moderate Renal Impairment (Panel C)
Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
OG003
Part 1: Control to Match Panel C (Panel D)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
OG004
Part 1: Severe Renal Impairment (Panel E)
Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
OG005
Part 1: Control to Match Panel E (Panel F)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
OG006
Part 2: ESRD Requiring HD (Panel G) - Period 1
Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G. In Period 1, participants received MK-3102 3 mg immediately after HD. One participant did not have an estimable parameter.
OG007
Part 2: Control to Match Panel G (Panel H) - Period 1
Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from the participant that withdrew from study was not included.
OG008
Part 2: ESRD Requiring HD (Panel G) - Period 2
Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.
OG009
Part 2: Control to Match Panel G (Panel H) - Period 2
Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from the participant that withdrew from study was not included.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0036
OG0046
OG0056
OG0065
OG0076
OG0086
OG0096
Title
Denominators
Categories
Title
Measurements
OG0004703.16(4078.19 to 5423.92)
OG0014983.58(4321.34 to 5747.31)
OG0025785.21(4950.03 to 6761.31)
OG0034312.17(3689.64 to 5039.74)
OG0046466.65(5577.34 to 7497.76)
OG0054142.94(3573.19 to 4803.53)
OG0067257.17(5595.73 to 9411.93)
OG0073842.62(2964.77 to 4980.39)
OG0087585.94(5852.93 to 9832.07)
OG0093842.62(2964.77 to 4980.39)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Geometric mean ratio (GMR)
GMR of Panel A:Panel B
GMR
0.94
2-Sided
90
0.80
1.11
Superiority or Other
OG002
OG003
GMR of Panel C:Panel D
GMR of Panel C:Panel D
1.34
2-Sided
90
1.12
1.61
Superiority or Other
OG004
OG005
GMR of Panel E:Panel F
GMR of Panel E:Panel F
1.56
2-Sided
90
1.32
1.85
Superiority or Other
OG006
OG007
GMR of Panel G:Panel H
GMR or Panel G:Panel H
1.89
2-Sided
90
1.40
2.55
Superiority or Other
OG008
OG009
GMR of Panel G:Panel H
GMR of Panel G:Panel H
1.97
2-Sided
90
1.46
2.66
Superiority or Other
Primary
Maximum Concentration (Cmax) of Omarigliptin
Cmax is a measure of the maximum amount of drug in the plasma after the dose is given.
All participants that received a single 3 mg dose of omarigliptin.
Posted
Geometric Mean
95% Confidence Interval
nM
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
ID
Title
Description
OG000
Part 1: Mild Renal Impairment (Panel A)
Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
OG001
Part 1: Control to Match Panel A (Panel B)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
OG002
Part 1: Moderate Renal Impairment (Panel C)
Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
OG003
Part 1: Control to Match Panel C (Panel D)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
OG004
Part 1: Severe Renal Impairment (Panel E)
Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
OG005
Part 1: Control to Match Panel E (Panel F)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
OG006
Part 2: ESRD Requiring HD (Panel G) - Period 1
Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G. In Period 1, participants received MK-3102 3 mg immediately after HD.
OG007
Part 2: Control to Match Panel G (Panel H) - Period 1
Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
OG008
Part 2: ESRD Requiring HD (Panel G) - Period 2
Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.
OG009
Part 2: Control to Match Panel G (Panel H) - Period 2
Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG00060.37± 51.82(51.82 to 70.34)
OG00164.03(54.96 to 74.61)
OG00261.43(50.64 to 74.52)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
GMR of Panel A:Panel B
GMR of Panel A:Panel B
0.94
2-Sided
90
0.79
1.12
Superiority or Other
OG002
OG003
GMR of Panel C:Panel D
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.
All participants that received a single 3 mg dose of omarigliptin.
Posted
Geometric Mean
95% Confidence Interval
nM*hr
Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, and 168 hours post-dose
ID
Title
Description
OG000
Part 1: Mild Renal Impairment (Panel A)
Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
OG001
Part 1: Control to Match Panel A (Panel B)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
OG002
Part 1: Moderate Renal Impairment (Panel C)
Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
OG003
Part 1: Control to Match Panel C (Panel D)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
OG004
Part 1: Severe Renal Impairment (Panel E)
Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
OG005
Part 1: Control to Match Panel E (Panel F)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
OG006
Part 2: ESRD Requiring HD (Panel G) - Period 1
Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G. In Period 1, participants received MK-3102 3 mg immediately after HD.
OG007
Part 2: Control to Match Panel G (Panel H) - Period 1
Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
OG008
Part 2: ESRD Requiring HD (Panel G) - Period 2
Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.
OG009
Part 2: Control to Match Panel G (Panel H) - Period 2
Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0003055.48(2720.74 to 3431.42)
OG0013315.01(2951.83 to 3722.87)
OG0023674.50(3037.78 to 4444.68)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
GMR of Panel A:Panel B
GMR of Panel A:Panel B
0.92
2-Sided
90
0.81
1.05
Superiority or Other
OG002
OG003
GMR of Panel C:Panel D
Primary
Concentration at 168 Hours Post-dose (C168h) of Omarigliptin
C168h is a measure of the plasma drug concentration 168 hours post-dose.
All participants that received a single 3 mg dose of omarigliptin.
Posted
Geometric Mean
95% Confidence Interval
nM
168 hours post-dose
ID
Title
Description
OG000
Part 1: Mild Renal Impairment (Panel A)
Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
OG001
Part 1: Control to Match Panel A (Panel B)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
OG002
Part 1: Moderate Renal Impairment (Panel C)
Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
OG003
Part 1: Control to Match Panel C (Panel D)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
OG004
Part 1: Severe Renal Impairment (Panel E)
Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
OG005
Part 1: Control to Match Panel E (Panel F)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
OG006
Part 2: ESRD Requiring HD (Panel G) - Period 1
Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G. In Period 1, participants received MK-3102 3 mg immediately after HD.
OG007
Part 2: Control to Match Panel G (Panel H) - Period 1
Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
OG008
Part 2: ESRD Requiring HD (Panel G) - Period 2
Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.
OG009
Part 2: Control to Match Panel G (Panel H) - Period 2
Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0007.19(6.06 to 8.53)
OG0017.85(6.62 to 9.31)
OG0029.10(7.68 to 10.78)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
GMR of Panel A:Panel B
GMR of Panel A:Panel B
0.92
2-Sided
90
0.75
1.12
Superiority or Other
OG002
OG003
GMR of Panel C:Panel D
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.
All participants that received a single 3 mg dose of omarigliptin.
Posted
Geometric Mean
95% Confidence Interval
L
Up to 336 hours post-dose
ID
Title
Description
OG000
Part 1: Mild Renal Impairment (Panel A)
Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
OG001
Part 1: Control to Match Panel A (Panel B)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
OG002
Part 1: Moderate Renal Impairment (Panel C)
Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
OG003
Part 1: Control to Match Panel C (Panel D)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
OG004
Part 1: Severe Renal Impairment (Panel E)
Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
OG005
Part 1: Control to Match Panel E (Panel F)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
OG006
Part 2: ESRD Requiring HD (Panel G) - Period 1
Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G. In Period 1, participants received MK-3102 3 mg immediately after HD. One participant did not have an estimable parameter.
OG007
Part 2: Control to Match Panel G (Panel H) - Period 1
Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from the participant that withdrew from study was not included.
OG008
Part 2: ESRD Requiring HD (Panel G) - Period 2
Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.
OG009
Part 2: Control to Match Panel G (Panel H) - Period 2
Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from the participant that withdrew from the study was not included.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG000349.42(282.17 to 432.69)
OG001314.39(253.88 to 389.31)
OG002295.86(218.39 to 400.82)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
GMR of Panel A:Panel B
GMR of Panel A:Panel B
1.11
2-Sided
90
0.87
1.42
Superiority or Other
OG002
OG003
GMR of Panel C:Panel D
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).
All participants that received a single 3 mg dose of omarigliptin.
Posted
Geometric Mean
95% Confidence Interval
mL/min
Up to 336 hours post-dose
ID
Title
Description
OG000
Part 1: Mild Renal Impairment (Panel A)
Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
OG001
Part 1: Control to Match Panel A (Panel B)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
OG002
Part 1: Moderate Renal Impairment (Panel C)
Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
OG003
Part 1: Control to Match Panel C (Panel D)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
OG004
Part 1: Severe Renal Impairment (Panel E)
Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
OG005
Part 1: Control to Match Panel E (Panel F)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
OG006
Part 2: ESRD Requiring HD (Panel G) - Period 1
Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G. In Period 1, participants received MK-3102 3 mg immediately after HD. One participant did not have an estimable parameter.
OG007
Part 2: Control to Match Panel G (Panel H) - Period 1
Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from the participant that withdrew from study was not included.
OG008
Part 2: ESRD Requiring HD (Panel G) - Period 2
Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.
OG009
Part 2: Control to Match Panel G (Panel H) - Period 2
Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from the participant that withdrew from study was not included.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG00026.51(22.98 to 30.57)
OG00125.02(21.69 to 28.85)
OG00221.55(18.44 to 25.18)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
GMR of Panel A:Panel B
GMR of Panel A:Panel B
1.06
2-Sided
90
0.90
1.25
Superiority or Other
OG002
OG003
GMR of Panel C:Panel D
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.
All participants that received a single 3 mg dose of omarigliptin.
Posted
Geometric Mean
95% Confidence Interval
mL/min
Up to 336 hours post-dose
ID
Title
Description
OG000
Part 1: Mild Renal Impairment (Panel A)
Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
OG001
Part 1: Control to Match Panel A (Panel B)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
OG002
Part 1: Moderate Renal Impairment (Panel C)
Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
OG003
Part 1: Control to Match Panel C (Panel D)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
OG004
Part 1: Severe Renal Impairment (Panel E)
Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
OG005
Part 1: Control to Match Panel E (Panel F)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG00027.26(22.25 to 33.41)
OG00129.27(23.89 to 35.87)
OG00217.93(14.06 to 22.87)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
GMR of Panel A:Panel B
GMR of Panel A:Panel B
0.93
2-Sided
90
0.74
1.18
Superiority or Other
OG002
OG003
GMR of Panel C:Panel D
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.
All participants that received a single 3 mg dose of omarigliptin.
Posted
Geometric Mean
95% Confidence Interval
Percentage of total dose
Up to 48 hours post-dose
ID
Title
Description
OG000
Part 1: Mild Renal Impairment (Panel A)
Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
OG001
Part 1: Control to Match Panel A (Panel B)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
OG002
Part 1: Moderate Renal Impairment (Panel C)
Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
OG003
Part 1: Control to Match Panel C (Panel D)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
OG004
Part 1: Severe Renal Impairment (Panel E)
Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
OG005
Part 1: Control to Match Panel E (Panel F)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG00035(29 to 43)
OG00141(34 to 50)
OG00227(22 to 33)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
GMR of Panel A:Panel B
GMR of Panel A:Panel B
0.86
2-Sided
90
0.69
1.07
Superiority or Other
OG002
OG003
GMR of Panel C:Panel D
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.
All participants that received a single 3 mg dose of omarigliptin.
Posted
Least Squares Mean
95% Confidence Interval
mg
Up to 48 hours post-dose
ID
Title
Description
OG000
Part 1: Mild Renal Impairment (Panel A)
Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
OG001
Part 1: Control to Match Panel A (Panel B)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
OG002
Part 1: Moderate Renal Impairment (Panel C)
Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
OG003
Part 1: Control to Match Panel C (Panel D)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
OG004
Part 1: Severe Renal Impairment (Panel E)
Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
OG005
Part 1: Control to Match Panel E (Panel F)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.04(0.86 to 1.25)
OG0011.21(1.00 to 1.46)
OG0020.79(0.64 to 0.98)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
GMR of Panel A:Panel B
GMR of Panel A:Panel B
0.86
2-Sided
90
0.69
1.07
Superiority or Other
OG002
OG003
GMR of Panel C:Panel D
Primary
Time to Maximum Concentration (Tmax) of Omarigliptin
Tmax is a measure of the time to reach the maximum drug plasma concentration post-dose.
All participants that received a single 3 mg dose of omarigliptin.
Posted
Median
Full Range
hour
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
ID
Title
Description
OG000
Part 1: Mild Renal Impairment (Panel A)
Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
OG001
Part 1: Control to Match Panel A (Panel B)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
OG002
Part 1: Moderate Renal Impairment (Panel C)
Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
OG003
Part 1: Control to Match Panel C (Panel D)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
OG004
Part 1: Severe Renal Impairment (Panel E)
Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
OG005
Part 1: Control to Match Panel E (Panel F)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
OG006
Part 2: ESRD Requiring HD (Panel G) - Period 1
Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G. In Period 1, participants received MK-3102 3 mg immediately after HD.
OG007
Part 2: Control to Match Panel G (Panel H) - Period 1
Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
OG008
Part 2: ESRD Requiring HD (Panel G) - Period 2
Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.
OG009
Part 2: Control to Match Panel G (Panel H) - Period 2
Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0003.0(1.0 to 4.0)
OG0011.5(1.0 to 4.0)
OG0022.0(1.0 to 6.0)
OG003
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%.
All participants that received a single 3 mg dose of omarigliptin.
Posted
Mean
Standard Deviation
hour
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
ID
Title
Description
OG000
Part 1: Mild Renal Impairment (Panel A)
Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
OG001
Part 1: Control to Match Panel A (Panel B)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
OG002
Part 1: Moderate Renal Impairment (Panel C)
Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
OG003
Part 1: Control to Match Panel C (Panel D)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
OG004
Part 1: Severe Renal Impairment (Panel E)
Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
OG005
Part 1: Control to Match Panel E (Panel F)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
OG006
Part 2: ESRD Requiring HD (Panel G) - Period 1
Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G. In Period 1, participants received MK-3102 3 mg immediately after HD. One participant did not have an estimable parameter.
OG007
Part 2: Control to Match Panel G (Panel H) - Period 1
Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from the participant that withdrew from study was not included.
OG008
Part 2: ESRD Requiring HD (Panel G) - Period 2
Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.
OG009
Part 2: Control to Match Panel G (Panel H) - Period 2
Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from the participant that withdrew from study was not included.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG000148.3± 39.0
OG001143.7± 21.9
OG002156.2± 32.0
OG003
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.
All participants that received a single 3 mg dose of omarigliptin.
Posted
Number
Participants
From pre-dose to 14 days post-dose (Up to Day 15)
ID
Title
Description
OG000
Part 1: Mild Renal Impairment (Panel A)
Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
OG001
Part 1: Control to Match Panel A (Panel B)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
OG002
Part 1: Moderate Renal Impairment (Panel C)
Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
OG003
Part 1: Control to Match Panel C (Panel D)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
OG004
Part 1: Severe Renal Impairment (Panel E)
Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
OG005
Part 1: Control to Match Panel E (Panel F)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
OG006
Part 2: ESRD Requiring HD (Panel G) - Periods 1 and 2
Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G.
OG007
Part 2: Control to Match Panel G (Panel H) - Period 1
Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0001
OG0011
OG0024
OG003
Secondary
Number of Participants Withdrawn From Study
All participants that received a single 3 mg dose of omarigliptin.
Posted
Number
Participants
Up to Day 15
ID
Title
Description
OG000
Part 1: Mild Renal Impairment (Panel A)
Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
OG001
Part 1: Control to Match Panel A (Panel B)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
OG002
Part 1: Moderate Renal Impairment (Panel C)
Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
OG003
Part 1: Control to Match Panel C (Panel D)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
OG004
Part 1: Severe Renal Impairment (Panel E)
Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
OG005
Part 1: Control to Match Panel E (Panel F)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
OG006
Part 2: ESRD Requiring HD (Panel G) - Periods 1 and 2
Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G.
OG007
Part 2: Control to Match Panel G (Panel H) - Period 1
Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
0
6
1
6
EG001
Part 1: Control to Match Panel A (Panel B)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
0
6
1
6
EG002
Part 1: Moderate Renal Impairment (Panel C)
Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
0
6
4
6
EG003
Part 1: Control to Match Panel C (Panel D)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
0
6
1
6
EG004
Part 1: Severe Renal Impairment (Panel E)
Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
0
6
1
6
EG005
Part 1: Control to Match Panel E (Panel F)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
0
6
1
6
EG006
Part 2: ESRD Requiring HD (Panel G)
Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD)
0
6
0
6
EG007
Part 2: Control to Match Panel G (Panel H)
Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
0
7
1
7
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected7 at risk
Nasopharyngitis
Infections and infestations
MedDRA v.15.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected7 at risk
Arthropod bite
Injury, poisoning and procedural complications
MedDRA v.15.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected7 at risk
Alanine aminotransferase increased
Investigations
MedDRA v.15.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected7 at risk
Aspartate aminotransferase increased
Investigations
MedDRA v.15.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected7 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v.15.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected7 at risk
Headache
Nervous system disorders
MedDRA v.15.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected6 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected7 at risk
Pollakiuria
Renal and urinary disorders
MedDRA v.15.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected7 at risk
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v.15.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected7 at risk
Eccymosis
Skin and subcutaneous tissue disorders
MedDRA v.15.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected7 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.
D005261
Female Urogenital Diseases and Pregnancy Complications