Phase 1
N=49
A Study of Omarigliptin (MK-3102) in Participants With Impaired Renal Function (MK-3102-009)
Chronic Renal Insufficiency · Type 2 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT01407276 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcome: Primary: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) of Omarigliptin — 4703.16; 4983.58; 5785.21; 4312.17 nM*hr
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Omarigliptin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) of Omarigliptin |
4703.16; 4983.58; 5785.21; 4312.17; 6466.65; 4142.94 | — |
| PRIMARY Maximum Concentration (Cmax) of Omarigliptin |
60.37; 64.03; 61.43; 54.34; 48.65; 53.89 | — |
| PRIMARY Area Under the Concentration-time Curve From Time 0 to 168 Hours Post Dose (AUC0-168h) of Omarigliptin |
3055.48; 3315.01; 3674.50; 2770.54; 3580.02; 2615.56 | — |
| PRIMARY Concentration at 168 Hours Post-dose (C168h) of Omarigliptin |
7.19; 7.85; 9.10; 6.28; 11.48; 6.28 | — |
| PRIMARY Apparent Volume of Distribution (Vd/F) of Omarigliptin |
349.42; 314.39; 295.86; 392.75; 280.58; 410.21 | — |
| PRIMARY Apparent Total Body Clearance (CL/F) of Omarigliptin |
26.51; 25.02; 21.55; 28.91; 19.28; 30.09 | — |
| PRIMARY Renal Clearance (CLr) of Omarigliptin |
27.26; 29.27; 17.93; 24.71; 12.18; 28.84 | — |
| PRIMARY Fraction of Dose Excreted Unchanged in Urine Through 48 Hours Post-dose (fe48h) of Omarigliptin |
35; 41; 27; 30; 15; 31 | — |
| PRIMARY Cumulative Amount of Drug Excreted in Urine Over 48 Hours (Ae0-48h) of Omarigliptin |
1.04; 1.21; 0.79; 0.88; 0.45; 0.90 | — |
| PRIMARY Time to Maximum Concentration (Tmax) of Omarigliptin |
3.0; 1.5; 2.0; 1.5; 2.0; 1.5 | — |
| PRIMARY Apparent Terminal Half-life (t1/2) of Omarigliptin |
148.3; 143.7; 156.2; 147.0; 159.8; 155.0 | — |
| SECONDARY Number of Participants Experiencing an Adverse Event (AE) |
1; 1; 4; 1; 1; 1 | — |
| SECONDARY Number of Participants Withdrawn From Study |
0; 0; 0; 0; 0; 0 | — |
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.
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
- Current or history of illicit drug abuse
- Nursing mothers
Data sourced from ClinicalTrials.gov (NCT01407276). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.