Trial Outcomes & Findings for A Study of Omarigliptin (MK-3102) in Participants With Impaired Renal Function (MK-3102-009) (NCT NCT01407276)

NCT ID: NCT01407276

Last Updated: 2018-09-10

Results Overview

AUC0-∞ is a measure of the mean concentration levels of drug in the plasma after the dose.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 49 participants
• Primary outcome timeframe: 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
• Results posted on: 2018-09-10

Participant Flow

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.

Participant milestones

Measure	Part 2: ESRD Requiring HD (Panel G) Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD)	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.	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.	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.	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.	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.	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.	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.
Overall Study STARTED	6	6	6	6	6	6	6	7
Overall Study COMPLETED	6	6	6	6	6	6	6	6
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	1

Reasons for withdrawal

Measure	Part 2: ESRD Requiring HD (Panel G) Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD)	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.	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.	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.	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.	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.	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.	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.
Overall Study Withdrawal by Subject	0	0	0	0	0	0	0	1

Baseline Characteristics

A Study of Omarigliptin (MK-3102) in Participants With Impaired Renal Function (MK-3102-009)

Baseline characteristics by cohort

Measure	Part 1: Mild Renal Impairment (Panel A) n=6 Participants Participants with estimated glomerular filtration rate (eGFR) ≥60 - \<80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.	Part 1: Control to Match Panel A (Panel B) n=6 Participants 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.	Part 1: Moderate Renal Impairment (Panel C) n=6 Participants Participants with eGFR ≥30 - \<60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.	Part 1: Control to Match Panel C (Panel D) n=6 Participants 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.	Part 1: Severe Renal Impairment (Panel E) n=6 Participants Participants with eGFR \<30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.	Part 1: Control to Match Panel E (Panel F) n=6 Participants 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.	Part 2: ESRD Requiring HD (Panel G) n=6 Participants Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD)	Part 2: Control to Match Panel G (Panel H) n=7 Participants 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.	Total n=49 Participants Total of all reporting groups
Age, Continuous	71 Years n=5 Participants	68 Years n=7 Participants	62 Years n=5 Participants	60 Years n=4 Participants	64 Years n=21 Participants	60 Years n=8 Participants	46 Years n=8 Participants	43 Years n=24 Participants	59 Years n=42 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	2 Participants n=8 Participants	3 Participants n=24 Participants	21 Participants n=42 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	4 Participants n=8 Participants	4 Participants n=8 Participants	4 Participants n=24 Participants	28 Participants n=42 Participants

PRIMARY outcome

Timeframe: 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

Population: All participants that received a single 3 mg dose of omarigliptin.

AUC0-∞ is a measure of the mean concentration levels of drug in the plasma after the dose.

Outcome measures

Measure	Part 1: Mild Renal Impairment (Panel A) n=6 Participants Participants with estimated glomerular filtration rate (eGFR) ≥60 - \<80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.	Part 1: Control to Match Panel A (Panel B) n=6 Participants 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.	Part 1: Moderate Renal Impairment (Panel C) n=6 Participants Participants with eGFR ≥30 - \<60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.	Part 1: Control to Match Panel C (Panel D) n=6 Participants 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.	Part 1: Severe Renal Impairment (Panel E) n=6 Participants Participants with eGFR \<30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.	Part 1: Control to Match Panel E (Panel F) n=6 Participants 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.	Part 2: ESRD Requiring HD (Panel G) - Period 1 n=5 Participants 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.	Part 2: Control to Match Panel G (Panel H) - Period 1 n=6 Participants 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.	Part 2: ESRD Requiring HD (Panel G) - Period 2 n=6 Participants Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.	Part 2: Control to Match Panel G (Panel H) - Period 2 n=6 Participants 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.
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) of Omarigliptin	4703.16 nM*hr Interval 4078.19 to 5423.92	4983.58 nM*hr Interval 4321.34 to 5747.31	5785.21 nM*hr Interval 4950.03 to 6761.31	4312.17 nM*hr Interval 3689.64 to 5039.74	6466.65 nM*hr Interval 5577.34 to 7497.76	4142.94 nM*hr Interval 3573.19 to 4803.53	7257.17 nM*hr Interval 5595.73 to 9411.93	3842.62 nM*hr Interval 2964.77 to 4980.39	7585.94 nM*hr Interval 5852.93 to 9832.07	3842.62 nM*hr Interval 2964.77 to 4980.39

PRIMARY outcome

Timeframe: 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

Population: All participants that received a single 3 mg dose of omarigliptin.

Cmax is a measure of the maximum amount of drug in the plasma after the dose is given.

Outcome measures

Measure	Part 1: Mild Renal Impairment (Panel A) n=6 Participants Participants with estimated glomerular filtration rate (eGFR) ≥60 - \<80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.	Part 1: Control to Match Panel A (Panel B) n=6 Participants 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.	Part 1: Moderate Renal Impairment (Panel C) n=6 Participants Participants with eGFR ≥30 - \<60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.	Part 1: Control to Match Panel C (Panel D) n=6 Participants 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.	Part 1: Severe Renal Impairment (Panel E) n=6 Participants Participants with eGFR \<30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.	Part 1: Control to Match Panel E (Panel F) n=6 Participants 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.	Part 2: ESRD Requiring HD (Panel G) - Period 1 n=6 Participants 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.	Part 2: Control to Match Panel G (Panel H) - Period 1 n=7 Participants 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.	Part 2: ESRD Requiring HD (Panel G) - Period 2 n=6 Participants Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.	Part 2: Control to Match Panel G (Panel H) - Period 2 n=7 Participants 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.
Maximum Concentration (Cmax) of Omarigliptin	60.37 nM 95% Confidence Interval 51.82 • Interval 51.82 to 70.34	64.03 nM Interval 54.96 to 74.61	61.43 nM Interval 50.64 to 74.52	54.34 nM Interval 44.8 to 65.92	48.65 nM Interval 37.29 to 63.48	53.89 nM Interval 41.3 to 70.31	41.43 nM Interval 32.67 to 52.54	56.06 nM Interval 44.99 to 69.85	40.98 nM Interval 32.31 to 51.97	56.06 nM Interval 44.99 to 69.85

PRIMARY outcome

Timeframe: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, and 168 hours post-dose

Population: All participants that received a single 3 mg dose 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.

Outcome measures

Measure	Part 1: Mild Renal Impairment (Panel A) n=6 Participants Participants with estimated glomerular filtration rate (eGFR) ≥60 - \<80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.	Part 1: Control to Match Panel A (Panel B) n=6 Participants 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.	Part 1: Moderate Renal Impairment (Panel C) n=6 Participants Participants with eGFR ≥30 - \<60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.	Part 1: Control to Match Panel C (Panel D) n=6 Participants 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.	Part 1: Severe Renal Impairment (Panel E) n=6 Participants Participants with eGFR \<30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.	Part 1: Control to Match Panel E (Panel F) n=6 Participants 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.	Part 2: ESRD Requiring HD (Panel G) - Period 1 n=6 Participants 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.	Part 2: Control to Match Panel G (Panel H) - Period 1 n=7 Participants 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.	Part 2: ESRD Requiring HD (Panel G) - Period 2 n=6 Participants Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.	Part 2: Control to Match Panel G (Panel H) - Period 2 n=7 Participants 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.
Area Under the Concentration-time Curve From Time 0 to 168 Hours Post Dose (AUC0-168h) of Omarigliptin	3055.48 nM*hr Interval 2720.74 to 3431.42	3315.01 nM*hr Interval 2951.83 to 3722.87	3674.50 nM*hr Interval 3037.78 to 4444.68	2770.54 nM*hr Interval 2290.46 to 3351.25	3580.02 nM*hr Interval 3040.51 to 4215.27	2615.56 nM*hr Interval 2221.4 to 3079.67	3352.27 nM*hr Interval 2653.44 to 4235.17	2431.77 nM*hr Interval 1958.5 to 3019.41	3150.93 nM*hr Interval 2494.07 to 3980.8	2431.77 nM*hr Interval 1958.5 to 3019.41

PRIMARY outcome

Timeframe: 168 hours post-dose

Population: All participants that received a single 3 mg dose of omarigliptin.

C168h is a measure of the plasma drug concentration 168 hours post-dose.

Outcome measures

Measure	Part 1: Mild Renal Impairment (Panel A) n=6 Participants Participants with estimated glomerular filtration rate (eGFR) ≥60 - \<80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.	Part 1: Control to Match Panel A (Panel B) n=6 Participants 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.	Part 1: Moderate Renal Impairment (Panel C) n=6 Participants Participants with eGFR ≥30 - \<60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.	Part 1: Control to Match Panel C (Panel D) n=6 Participants 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.	Part 1: Severe Renal Impairment (Panel E) n=6 Participants Participants with eGFR \<30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.	Part 1: Control to Match Panel E (Panel F) n=6 Participants 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.	Part 2: ESRD Requiring HD (Panel G) - Period 1 n=6 Participants 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.	Part 2: Control to Match Panel G (Panel H) - Period 1 n=7 Participants 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.	Part 2: ESRD Requiring HD (Panel G) - Period 2 n=6 Participants Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.	Part 2: Control to Match Panel G (Panel H) - Period 2 n=7 Participants 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.
Concentration at 168 Hours Post-dose (C168h) of Omarigliptin	7.19 nM Interval 6.06 to 8.53	7.85 nM Interval 6.62 to 9.31	9.10 nM Interval 7.68 to 10.78	6.28 nM Interval 5.3 to 7.44	11.48 nM Interval 9.64 to 13.69	6.28 nM Interval 5.27 to 7.49	11.46 nM Interval 8.81 to 14.91	6.05 nM Interval 4.74 to 7.71	11.35 nM Interval 8.72 to 14.76	6.05 nM Interval 4.74 to 7.71

PRIMARY outcome

Timeframe: Up to 336 hours post-dose

Population: All participants that received a single 3 mg dose 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.

Outcome measures

Measure	Part 1: Mild Renal Impairment (Panel A) n=6 Participants Participants with estimated glomerular filtration rate (eGFR) ≥60 - \<80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.	Part 1: Control to Match Panel A (Panel B) n=6 Participants 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.	Part 1: Moderate Renal Impairment (Panel C) n=6 Participants Participants with eGFR ≥30 - \<60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.	Part 1: Control to Match Panel C (Panel D) n=6 Participants 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.	Part 1: Severe Renal Impairment (Panel E) n=6 Participants Participants with eGFR \<30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.	Part 1: Control to Match Panel E (Panel F) n=6 Participants 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.	Part 2: ESRD Requiring HD (Panel G) - Period 1 n=5 Participants 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.	Part 2: Control to Match Panel G (Panel H) - Period 1 n=6 Participants 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.	Part 2: ESRD Requiring HD (Panel G) - Period 2 n=6 Participants Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.	Part 2: Control to Match Panel G (Panel H) - Period 2 n=6 Participants 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.
Apparent Volume of Distribution (Vd/F) of Omarigliptin	349.42 L Interval 282.17 to 432.69	314.39 L Interval 253.88 to 389.31	295.86 L Interval 218.39 to 400.82	392.75 L Interval 289.9 to 532.08	280.58 L Interval 216.3 to 363.95	410.21 L Interval 316.24 to 532.11	334.57 L Interval 249.27 to 449.07	478.52 L Interval 357.04 to 641.32	383.12 L Interval 285.87 to 513.47	478.52 L Interval 357.04 to 641.32

PRIMARY outcome

Timeframe: Up to 336 hours post-dose

Population: All participants that received a single 3 mg dose 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).

Outcome measures

Measure	Part 1: Mild Renal Impairment (Panel A) n=6 Participants Participants with estimated glomerular filtration rate (eGFR) ≥60 - \<80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.	Part 1: Control to Match Panel A (Panel B) n=6 Participants 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.	Part 1: Moderate Renal Impairment (Panel C) n=6 Participants Participants with eGFR ≥30 - \<60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.	Part 1: Control to Match Panel C (Panel D) n=6 Participants 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.	Part 1: Severe Renal Impairment (Panel E) n=6 Participants Participants with eGFR \<30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.	Part 1: Control to Match Panel E (Panel F) n=6 Participants 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.	Part 2: ESRD Requiring HD (Panel G) - Period 1 n=5 Participants 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.	Part 2: Control to Match Panel G (Panel H) - Period 1 n=6 Participants 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.	Part 2: ESRD Requiring HD (Panel G) - Period 2 n=6 Participants Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.	Part 2: Control to Match Panel G (Panel H) - Period 2 n=6 Participants 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.
Apparent Total Body Clearance (CL/F) of Omarigliptin	26.51 mL/min Interval 22.98 to 30.57	25.02 mL/min Interval 21.69 to 28.85	21.55 mL/min Interval 18.44 to 25.18	28.91 mL/min Interval 24.74 to 33.79	19.28 mL/min Interval 16.63 to 22.35	30.09 mL/min Interval 25.95 to 34.89	17.18 mL/min Interval 13.25 to 22.28	32.44 mL/min Interval 25.03 to 42.05	16.43 mL/min Interval 12.68 to 21.3	32.44 mL/min Interval 25.03 to 42.05

PRIMARY outcome

Timeframe: Up to 336 hours post-dose

Population: All participants that received a single 3 mg dose 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.

Outcome measures

Measure	Part 1: Mild Renal Impairment (Panel A) n=6 Participants Participants with estimated glomerular filtration rate (eGFR) ≥60 - \<80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.	Part 1: Control to Match Panel A (Panel B) n=6 Participants 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.	Part 1: Moderate Renal Impairment (Panel C) n=6 Participants Participants with eGFR ≥30 - \<60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.	Part 1: Control to Match Panel C (Panel D) n=6 Participants 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.	Part 1: Severe Renal Impairment (Panel E) n=6 Participants Participants with eGFR \<30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.	Part 1: Control to Match Panel E (Panel F) n=6 Participants 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.	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.	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.	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.	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.
Renal Clearance (CLr) of Omarigliptin	27.26 mL/min Interval 22.25 to 33.41	29.27 mL/min Interval 23.89 to 35.87	17.93 mL/min Interval 14.06 to 22.87	24.71 mL/min Interval 19.37 to 31.52	12.18 mL/min Interval 9.79 to 15.14	28.84 mL/min Interval 23.19 to 35.86	—	—	—	—

PRIMARY outcome

Timeframe: Up to 48 hours post-dose

Population: All participants that received a single 3 mg dose of omarigliptin.

fe48h is expressed as percentage of omarigliptin not metabolized and excreted in urine. fe48h was only determined for Panels A-F.

Outcome measures

Measure	Part 1: Mild Renal Impairment (Panel A) n=6 Participants Participants with estimated glomerular filtration rate (eGFR) ≥60 - \<80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.	Part 1: Control to Match Panel A (Panel B) n=6 Participants 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.	Part 1: Moderate Renal Impairment (Panel C) n=6 Participants Participants with eGFR ≥30 - \<60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.	Part 1: Control to Match Panel C (Panel D) n=6 Participants 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.	Part 1: Severe Renal Impairment (Panel E) n=6 Participants Participants with eGFR \<30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.	Part 1: Control to Match Panel E (Panel F) n=6 Participants 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.	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.	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.	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.	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.
Fraction of Dose Excreted Unchanged in Urine Through 48 Hours Post-dose (fe48h) of Omarigliptin	35 Percentage of total dose Interval 29.0 to 43.0	41 Percentage of total dose Interval 34.0 to 50.0	27 Percentage of total dose Interval 22.0 to 33.0	30 Percentage of total dose Interval 24.0 to 37.0	15 Percentage of total dose Interval 12.0 to 20.0	31 Percentage of total dose Interval 24.0 to 40.0	—	—	—	—

PRIMARY outcome

Timeframe: Up to 48 hours post-dose

Population: All participants that received a single 3 mg dose 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.

Outcome measures

Measure	Part 1: Mild Renal Impairment (Panel A) n=6 Participants Participants with estimated glomerular filtration rate (eGFR) ≥60 - \<80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.	Part 1: Control to Match Panel A (Panel B) n=6 Participants 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.	Part 1: Moderate Renal Impairment (Panel C) n=6 Participants Participants with eGFR ≥30 - \<60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.	Part 1: Control to Match Panel C (Panel D) n=6 Participants 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.	Part 1: Severe Renal Impairment (Panel E) n=6 Participants Participants with eGFR \<30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.	Part 1: Control to Match Panel E (Panel F) n=6 Participants 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.	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.	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.	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.	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.
Cumulative Amount of Drug Excreted in Urine Over 48 Hours (Ae0-48h) of Omarigliptin	1.04 mg Interval 0.86 to 1.25	1.21 mg Interval 1.0 to 1.46	0.79 mg Interval 0.64 to 0.98	0.88 mg Interval 0.71 to 1.1	0.45 mg Interval 0.35 to 0.58	0.90 mg Interval 0.7 to 1.16	—	—	—	—

PRIMARY outcome

Timeframe: 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

Population: All participants that received a single 3 mg dose of omarigliptin.

Tmax is a measure of the time to reach the maximum drug plasma concentration post-dose.

Outcome measures

Measure	Part 1: Mild Renal Impairment (Panel A) n=6 Participants Participants with estimated glomerular filtration rate (eGFR) ≥60 - \<80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.	Part 1: Control to Match Panel A (Panel B) n=6 Participants 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.	Part 1: Moderate Renal Impairment (Panel C) n=6 Participants Participants with eGFR ≥30 - \<60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.	Part 1: Control to Match Panel C (Panel D) n=6 Participants 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.	Part 1: Severe Renal Impairment (Panel E) n=6 Participants Participants with eGFR \<30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.	Part 1: Control to Match Panel E (Panel F) n=6 Participants 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.	Part 2: ESRD Requiring HD (Panel G) - Period 1 n=6 Participants 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.	Part 2: Control to Match Panel G (Panel H) - Period 1 n=7 Participants 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.	Part 2: ESRD Requiring HD (Panel G) - Period 2 n=6 Participants Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.	Part 2: Control to Match Panel G (Panel H) - Period 2 n=7 Participants 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.
Time to Maximum Concentration (Tmax) of Omarigliptin	3.0 hour Interval 1.0 to 4.0	1.5 hour Interval 1.0 to 4.0	2.0 hour Interval 1.0 to 6.0	1.5 hour Interval 1.0 to 2.0	2.0 hour Interval 1.0 to 6.0	1.5 hour Interval 1.0 to 2.0	4.0 hour Interval 2.0 to 6.0	1.0 hour Interval 0.5 to 4.0	4.0 hour Interval 1.0 to 6.2	1.0 hour Interval 0.5 to 4.0

PRIMARY outcome

Timeframe: 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

Population: All participants that received a single 3 mg dose of omarigliptin.

T1/2 is the time required for the maximum concentration of a drug in the plasma to decrease by 50%.

Outcome measures

Measure	Part 1: Mild Renal Impairment (Panel A) n=6 Participants Participants with estimated glomerular filtration rate (eGFR) ≥60 - \<80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.	Part 1: Control to Match Panel A (Panel B) n=6 Participants 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.	Part 1: Moderate Renal Impairment (Panel C) n=6 Participants Participants with eGFR ≥30 - \<60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.	Part 1: Control to Match Panel C (Panel D) n=6 Participants 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.	Part 1: Severe Renal Impairment (Panel E) n=6 Participants Participants with eGFR \<30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.	Part 1: Control to Match Panel E (Panel F) n=6 Participants 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.	Part 2: ESRD Requiring HD (Panel G) - Period 1 n=5 Participants 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.	Part 2: Control to Match Panel G (Panel H) - Period 1 n=6 Participants 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.	Part 2: ESRD Requiring HD (Panel G) - Period 2 n=6 Participants Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.	Part 2: Control to Match Panel G (Panel H) - Period 2 n=6 Participants 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.
Apparent Terminal Half-life (t1/2) of Omarigliptin	148.3 hour Standard Deviation 39.0	143.7 hour Standard Deviation 21.9	156.2 hour Standard Deviation 32.0	147.0 hour Standard Deviation 65.4	159.8 hour Standard Deviation 55.7	155.0 hour Standard Deviation 33.5	215.4 hour Standard Deviation 38.7	162.6 hour Standard Deviation 53.7	263.7 hour Standard Deviation 62.7	162.6 hour Standard Deviation 53.7

SECONDARY outcome

Timeframe: From pre-dose to 14 days post-dose (Up to Day 15)

Population: All participants that received a single 3 mg dose of omarigliptin.

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.

Outcome measures

Measure	Part 1: Mild Renal Impairment (Panel A) n=6 Participants Participants with estimated glomerular filtration rate (eGFR) ≥60 - \<80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.	Part 1: Control to Match Panel A (Panel B) n=6 Participants 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.	Part 1: Moderate Renal Impairment (Panel C) n=6 Participants Participants with eGFR ≥30 - \<60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.	Part 1: Control to Match Panel C (Panel D) n=6 Participants 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.	Part 1: Severe Renal Impairment (Panel E) n=6 Participants Participants with eGFR \<30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.	Part 1: Control to Match Panel E (Panel F) n=6 Participants 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.	Part 2: ESRD Requiring HD (Panel G) - Period 1 n=6 Participants 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.	Part 2: Control to Match Panel G (Panel H) - Period 1 n=7 Participants 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.	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.	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.
Number of Participants Experiencing an Adverse Event (AE)	1 Participants	1 Participants	4 Participants	1 Participants	1 Participants	1 Participants	0 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: Up to Day 15

Population: All participants that received a single 3 mg dose of omarigliptin.

Outcome measures

Measure	Part 1: Mild Renal Impairment (Panel A) n=6 Participants Participants with estimated glomerular filtration rate (eGFR) ≥60 - \<80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.	Part 1: Control to Match Panel A (Panel B) n=6 Participants 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.	Part 1: Moderate Renal Impairment (Panel C) n=6 Participants Participants with eGFR ≥30 - \<60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.	Part 1: Control to Match Panel C (Panel D) n=6 Participants 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.	Part 1: Severe Renal Impairment (Panel E) n=6 Participants Participants with eGFR \<30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.	Part 1: Control to Match Panel E (Panel F) n=6 Participants 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.	Part 2: ESRD Requiring HD (Panel G) - Period 1 n=6 Participants 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.	Part 2: Control to Match Panel G (Panel H) - Period 1 n=7 Participants 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.	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.	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.
Number of Participants Withdrawn From Study	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—

Adverse Events

Part 1: Mild Renal Impairment (Panel A)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 1: Control to Match Panel A (Panel B)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 1: Moderate Renal Impairment (Panel C)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Part 1: Control to Match Panel C (Panel D)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 1: Severe Renal Impairment (Panel E)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 1: Control to Match Panel E (Panel F)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 2: ESRD Requiring HD (Panel G)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 2: Control to Match Panel G (Panel H)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Part 1: Mild Renal Impairment (Panel A) n=6 participants at risk Participants with estimated glomerular filtration rate (eGFR) ≥60 - \<80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.	Part 1: Control to Match Panel A (Panel B) n=6 participants at risk 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.	Part 1: Moderate Renal Impairment (Panel C) n=6 participants at risk Participants with eGFR ≥30 - \<60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.	Part 1: Control to Match Panel C (Panel D) n=6 participants at risk 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.	Part 1: Severe Renal Impairment (Panel E) n=6 participants at risk Participants with eGFR \<30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.	Part 1: Control to Match Panel E (Panel F) n=6 participants at risk 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.	Part 2: ESRD Requiring HD (Panel G) n=6 participants at risk Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD)	Part 2: Control to Match Panel G (Panel H) n=7 participants at risk 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.
Infections and infestations Laryngitis	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	16.7% 1/6 • Number of events 1 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/7 • From pre-dose to 14 days post-dose (up to Day 15) 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.
Infections and infestations Nasopharyngitis	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	16.7% 1/6 • Number of events 1 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/7 • From pre-dose to 14 days post-dose (up to Day 15) 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.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	16.7% 1/6 • Number of events 1 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/7 • From pre-dose to 14 days post-dose (up to Day 15) 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.
Investigations Alanine aminotransferase increased	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	16.7% 1/6 • Number of events 1 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/7 • From pre-dose to 14 days post-dose (up to Day 15) 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.
Investigations Aspartate aminotransferase increased	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	16.7% 1/6 • Number of events 2 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/7 • From pre-dose to 14 days post-dose (up to Day 15) 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.
Musculoskeletal and connective tissue disorders Back pain	16.7% 1/6 • Number of events 1 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/7 • From pre-dose to 14 days post-dose (up to Day 15) 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.
Nervous system disorders Headache	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	33.3% 2/6 • Number of events 2 • From pre-dose to 14 days post-dose (up to Day 15) 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.	16.7% 1/6 • Number of events 1 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	14.3% 1/7 • Number of events 1 • From pre-dose to 14 days post-dose (up to Day 15) 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.
Renal and urinary disorders Pollakiuria	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	16.7% 1/6 • Number of events 1 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/7 • From pre-dose to 14 days post-dose (up to Day 15) 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.
Respiratory, thoracic and mediastinal disorders Nasal congestion	16.7% 1/6 • Number of events 1 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/7 • From pre-dose to 14 days post-dose (up to Day 15) 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.
Skin and subcutaneous tissue disorders Eccymosis	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	16.7% 1/6 • Number of events 1 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/6 • From pre-dose to 14 days post-dose (up to Day 15) 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.	0.00% 0/7 • From pre-dose to 14 days post-dose (up to Day 15) 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.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER