Trial Outcomes & Findings for A Single-Dose Study to Investigate the Pharmacokinetics of MK-7655 in Participants With Impaired Renal Function (MK-7655-005) (NCT NCT01275170)

Results Overview

AUC0-∞ is a measure of the mean (extrapolated) plasma drug concentration after dosing to infinity.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

49 participants

Primary outcome timeframe

Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose

Results posted on

2020-06-11

Participant Flow

Participants with varying degrees of renal impairment, or with end-stage renal disease (ESRD) requiring hemodialysis (HD) \[based on estimated glomerular filtration rate (eGFR)\], or healthy matched controls were enrolled at 2 study sites in the United States.

All panels participated in Part 1 of the study. Panels E to H also participated in Part 2 of the study.

Participant milestones

Participant milestones
Measure	Panel A: Mild Renal Impairment Participants with an eGFR of \>50 to \<80 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel B: Healthy Controls to Panel A Healthy control participants were matched specifically to participants in Panel A and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel C: Moderate Renal Impairment Participants with an eGFR of 30 to 50 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel D: Healthy Controls to Panel C Healthy control participants were matched specifically to participants in Panel C and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel E: Severe Renal Impairment Participants with an eGFR \<30 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1. In Part 2, participants receive an oral cocktail containing caffeine 200 mg, midazolam 2 mg, and omeprazole 40 mg.	Panel F: Healthy Controls to Panel E A subset of healthy control participants was matched specifically to participants in Panel E and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Participants Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2). In Part 2, participants receive an oral cocktail containing caffeine 200 mg, midazolam 2 mg, and omeprazole 40 mg predialysis (Part 2, Period 1) and postdialysis (Part 2, Period 2).	Panel H: Healthy Controls to Panel G Healthy control participants were matched specifically to participants in Panel G and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.
Part 1: Period 1 STARTED	7	6	6	6	6	6	6	6
Part 1: Period 1 Treated	6	6	6	6	6	6	6	6
Part 1: Period 1 COMPLETED	6	6	6	6	6	6	6	6
Part 1: Period 1 NOT COMPLETED	1	0	0	0	0	0	0	0
Part 1: Period 2 STARTED	0	0	0	0	0	0	6	6
Part 1: Period 2 COMPLETED	0	0	0	0	0	0	6	6
Part 1: Period 2 NOT COMPLETED	0	0	0	0	0	0	0	0
Part 2: Period 1 STARTED	0	0	0	0	6	6	6	6
Part 2: Period 1 COMPLETED	0	0	0	0	6	6	6	6
Part 2: Period 1 NOT COMPLETED	0	0	0	0	0	0	0	0
Part 2: Period 2 STARTED	0	0	0	0	0	0	6	6
Part 2: Period 2 COMPLETED	0	0	0	0	0	0	6	6
Part 2: Period 2 NOT COMPLETED	0	0	0	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Panel A: Mild Renal Impairment Participants with an eGFR of \>50 to \<80 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel B: Healthy Controls to Panel A Healthy control participants were matched specifically to participants in Panel A and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel C: Moderate Renal Impairment Participants with an eGFR of 30 to 50 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel D: Healthy Controls to Panel C Healthy control participants were matched specifically to participants in Panel C and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel E: Severe Renal Impairment Participants with an eGFR \<30 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1. In Part 2, participants receive an oral cocktail containing caffeine 200 mg, midazolam 2 mg, and omeprazole 40 mg.	Panel F: Healthy Controls to Panel E A subset of healthy control participants was matched specifically to participants in Panel E and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Participants Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2). In Part 2, participants receive an oral cocktail containing caffeine 200 mg, midazolam 2 mg, and omeprazole 40 mg predialysis (Part 2, Period 1) and postdialysis (Part 2, Period 2).	Panel H: Healthy Controls to Panel G Healthy control participants were matched specifically to participants in Panel G and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.
Part 1: Period 1 Equipment malfunction before study drug	1	0	0	0	0	0	0	0

Baseline Characteristics

A Single-Dose Study to Investigate the Pharmacokinetics of MK-7655 in Participants With Impaired Renal Function (MK-7655-005)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Panel A: Mild Renal Impairment n=7 Participants Participants with an eGFR of \>50 to \<80 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel B: Healthy Controls to Panel A n=6 Participants Healthy control participants were matched specifically to participants in Panel A and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel C: Moderate Renal Impairment n=6 Participants Participants with an eGFR of 30 to 50 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel D: Healthy Controls to Panel C n=6 Participants Healthy control participants were matched specifically to participants in Panel C and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel E: Severe Renal Impairment n=6 Participants Participants with an eGFR \<30 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1. In Part 2, participants receive an oral cocktail containing caffeine 200 mg, midazolam 2 mg, and omeprazole 40 mg.	Panel F: Healthy Controls to Panel E n=6 Participants A subset of healthy control participants was matched specifically to participants in Panel E and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Participants n=6 Participants Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2). In Part 2, participants receive an oral cocktail containing caffeine 200 mg, midazolam 2 mg, and omeprazole 40 mg predialysis (Part 2, Period 1) and postdialysis (Part 2, Period 2).	Panel H: Healthy Controls to Panel G n=6 Participants Healthy control participants were matched specifically to participants in Panel G and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Total n=49 Participants Total of all reporting groups
Age, Continuous	71.1 Years STANDARD_DEVIATION 3.4 • n=5 Participants	64.5 Years STANDARD_DEVIATION 3.9 • n=7 Participants	68.3 Years STANDARD_DEVIATION 5.0 • n=5 Participants	64.2 Years STANDARD_DEVIATION 5.7 • n=4 Participants	62.8 Years STANDARD_DEVIATION 7.5 • n=21 Participants	60.5 Years STANDARD_DEVIATION 6.4 • n=10 Participants	44.5 Years STANDARD_DEVIATION 7.9 • n=115 Participants	41.5 Years STANDARD_DEVIATION 11.5 • n=6 Participants	59.9 Years STANDARD_DEVIATION 12.1 • n=6 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=10 Participants	2 Participants n=115 Participants	2 Participants n=6 Participants	21 Participants n=6 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=10 Participants	4 Participants n=115 Participants	4 Participants n=6 Participants	28 Participants n=6 Participants

PRIMARY outcome

Timeframe: Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose

Population: Treated participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, data for Panel G were reported separately for post-dialysis and pre-dialysis.

AUC0-∞ is a measure of the mean (extrapolated) plasma drug concentration after dosing to infinity.

Outcome measures

Outcome measures
Measure	Panel A: Mild Renal Impairment n=6 Participants Participants with an eGFR of \>50 to \<80 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel B: Healthy Controls to Panel A n=6 Participants Healthy control participants were matched specifically to participants in Panel A and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel C: Moderate Renal Impairment n=6 Participants Participants with an eGFR of 30 to 50 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel D: Healthy Controls to Panel C n=6 Participants Healthy control participants were matched specifically to participants in Panel C and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel E: Severe Renal Impairment n=6 Participants Participants with an eGFR \<30 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel F: Healthy Controls to Panel E n=6 Participants A subset of healthy control participants was matched specifically to participants in Panel E and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 1 Postdialysis n=6 Participants Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).	Panel H: Healthy Controls to Panel G n=6 Participants Healthy control participants were matched specifically to participants in Panel G and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 2 Predialysis n=6 Participants Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).
Part 1: Area Under the Plasma Concentration-time Curve From Dosing to Infinity (AUC0-inf) of MK-7655 in Combination With PRIMAXIN®	73.5 µM*hr Interval 50.0 to 108.0	45.0 µM*hr Interval 32.4 to 62.6	115 µM*hr Interval 79.8 to 165.0	52.3 µM*hr Interval 37.7 to 72.7	236 µM*hr Interval 171.0 to 325.0	48.5 µM*hr Interval 35.3 to 66.4	414 µM*hr Interval 280.0 to 612.0	44.5 µM*hr Interval 29.1 to 67.9	78.0 µM*hr Interval 50.3 to 121.0

PRIMARY outcome

Timeframe: 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours postdose

Population: Treated participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, only Panel G participants requiring HD were included in the analysis.

The CLD of MK-7655 was determined in ESRD/HD participants for 4.5 hours during HD. The formula for calculating CLD was: CLd = (1-Hct)\*QB\*\[(pre-dialyzer concentration - post-dialyzer concentration) / (pre-dialyzer concentration)\] where QB=350 mL/min and Hct=hematocrit.

Outcome measures

Outcome measures
Measure	Panel A: Mild Renal Impairment n=6 Participants Participants with an eGFR of \>50 to \<80 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel B: Healthy Controls to Panel A Healthy control participants were matched specifically to participants in Panel A and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel C: Moderate Renal Impairment Participants with an eGFR of 30 to 50 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel D: Healthy Controls to Panel C Healthy control participants were matched specifically to participants in Panel C and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel E: Severe Renal Impairment Participants with an eGFR \<30 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel F: Healthy Controls to Panel E A subset of healthy control participants was matched specifically to participants in Panel E and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 1 Postdialysis Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).	Panel H: Healthy Controls to Panel G Healthy control participants were matched specifically to participants in Panel G and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 2 Predialysis Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).
Dialysis Clearance (CLD) of MK-7655 in Participants With End-stage Renal Diseases Requiring Hemodialysis (ESRD/HD) 1 hour postdose	172 mL/min Geometric Coefficient of Variation 3.5	—	—	—	—	—	—	—	—
Dialysis Clearance (CLD) of MK-7655 in Participants With End-stage Renal Diseases Requiring Hemodialysis (ESRD/HD) 1.5 hours postdose	158 mL/min Geometric Coefficient of Variation 9.4	—	—	—	—	—	—	—	—
Dialysis Clearance (CLD) of MK-7655 in Participants With End-stage Renal Diseases Requiring Hemodialysis (ESRD/HD) 2 hours postdose	170 mL/min Geometric Coefficient of Variation 5.9	—	—	—	—	—	—	—	—
Dialysis Clearance (CLD) of MK-7655 in Participants With End-stage Renal Diseases Requiring Hemodialysis (ESRD/HD) 2.5 hours postdose	166 mL/min Geometric Coefficient of Variation 7.0	—	—	—	—	—	—	—	—
Dialysis Clearance (CLD) of MK-7655 in Participants With End-stage Renal Diseases Requiring Hemodialysis (ESRD/HD) 3.0 hours postdose	171 mL/min Geometric Coefficient of Variation 5.4	—	—	—	—	—	—	—	—
Dialysis Clearance (CLD) of MK-7655 in Participants With End-stage Renal Diseases Requiring Hemodialysis (ESRD/HD) 3.5 hours postdose	177 mL/min Geometric Coefficient of Variation 15.7	—	—	—	—	—	—	—	—
Dialysis Clearance (CLD) of MK-7655 in Participants With End-stage Renal Diseases Requiring Hemodialysis (ESRD/HD) 4 hours postdose	204 mL/min Geometric Coefficient of Variation 20.2	—	—	—	—	—	—	—	—
Dialysis Clearance (CLD) of MK-7655 in Participants With End-stage Renal Diseases Requiring Hemodialysis (ESRD/HD) 4.5 hours postdose	198 mL/min Geometric Coefficient of Variation 23.0	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours postdose

Population: Treated participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, only Panel G is included in the analysis.

The extraction coefficient of MK-7655 was determined in ESRD/HD participants for 4.5 hours during HD. The formula for calculating extraction coefficient was: Extraction Coefficient = ABS\[100\*(post-dialyzer concentration - pre-dialyzer concentration) / pre-dialyzer concentration\].

Outcome measures

Outcome measures
Measure	Panel A: Mild Renal Impairment n=6 Participants Participants with an eGFR of \>50 to \<80 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel B: Healthy Controls to Panel A Healthy control participants were matched specifically to participants in Panel A and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel C: Moderate Renal Impairment Participants with an eGFR of 30 to 50 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel D: Healthy Controls to Panel C Healthy control participants were matched specifically to participants in Panel C and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel E: Severe Renal Impairment Participants with an eGFR \<30 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel F: Healthy Controls to Panel E A subset of healthy control participants was matched specifically to participants in Panel E and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 1 Postdialysis Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).	Panel H: Healthy Controls to Panel G Healthy control participants were matched specifically to participants in Panel G and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 2 Predialysis Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).
Extraction Coefficient of MK-7655 in Participants With End-stage Renal Diseases Requiring Hemodialysis (ESRD/HD) 1 hour postdose	73 Extraction coefficient Geometric Coefficient of Variation 1.8	—	—	—	—	—	—	—	—
Extraction Coefficient of MK-7655 in Participants With End-stage Renal Diseases Requiring Hemodialysis (ESRD/HD) 1.5 hours postdose	67 Extraction coefficient Geometric Coefficient of Variation 9.5	—	—	—	—	—	—	—	—
Extraction Coefficient of MK-7655 in Participants With End-stage Renal Diseases Requiring Hemodialysis (ESRD/HD) 2 hours postdose	73 Extraction coefficient Geometric Coefficient of Variation 4.5	—	—	—	—	—	—	—	—
Extraction Coefficient of MK-7655 in Participants With End-stage Renal Diseases Requiring Hemodialysis (ESRD/HD) 2.5 hours postdose	71 Extraction coefficient Geometric Coefficient of Variation 5.6	—	—	—	—	—	—	—	—
Extraction Coefficient of MK-7655 in Participants With End-stage Renal Diseases Requiring Hemodialysis (ESRD/HD) 3.0 hours postdose	73 Extraction coefficient Geometric Coefficient of Variation 4.1	—	—	—	—	—	—	—	—
Extraction Coefficient of MK-7655 in Participants With End-stage Renal Diseases Requiring Hemodialysis (ESRD/HD) 3.5 hours postdose	76 Extraction coefficient Geometric Coefficient of Variation 15.7	—	—	—	—	—	—	—	—
Extraction Coefficient of MK-7655 in Participants With End-stage Renal Diseases Requiring Hemodialysis (ESRD/HD) 4 hours postdose	87 Extraction coefficient Geometric Coefficient of Variation 19.6	—	—	—	—	—	—	—	—
Extraction Coefficient of MK-7655 in Participants With End-stage Renal Diseases Requiring Hemodialysis (ESRD/HD) 4.5 hours postdose	84 Extraction coefficient Geometric Coefficient of Variation 22.2	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At 0.5 hours postdose

Population: Treated participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, data for Panel G were reported separately for post-dialysis and pre-dialysis.

Ceoi is the observed plasma drug concentration at the end of IV infusion.

Outcome measures

Outcome measures
Measure	Panel A: Mild Renal Impairment n=6 Participants Participants with an eGFR of \>50 to \<80 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel B: Healthy Controls to Panel A n=6 Participants Healthy control participants were matched specifically to participants in Panel A and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel C: Moderate Renal Impairment n=6 Participants Participants with an eGFR of 30 to 50 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel D: Healthy Controls to Panel C n=6 Participants Healthy control participants were matched specifically to participants in Panel C and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel E: Severe Renal Impairment n=6 Participants Participants with an eGFR \<30 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel F: Healthy Controls to Panel E n=6 Participants A subset of healthy control participants was matched specifically to participants in Panel E and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 1 Postdialysis n=6 Participants Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).	Panel H: Healthy Controls to Panel G n=6 Participants Healthy control participants were matched specifically to participants in Panel G and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 2 Predialysis n=6 Participants Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).
Part 1: Concentration at End of Infusion (Ceoi) of MK-7655 in Combination With PRIMAXIN®	22.4 µM Interval 13.0 to 38.7	20.4 µM Interval 12.8 to 32.7	23.5 µM Interval 14.0 to 39.4	22.5 µM Interval 14.1 to 35.9	23.6 µM Interval 15.0 to 37.2	18.1 µM Interval 11.6 to 28.4	53.1 µM Interval 30.7 to 91.9	22.7 µM Interval 12.5 to 41.0	19.3 µM Interval 11.2 to 33.4

SECONDARY outcome

Timeframe: Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose

Population: Treated participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, data for Panel G were reported separately for post-dialysis and pre-dialysis.

CLpred is the predicted apparent total body clearance of drug.

Outcome measures

Outcome measures
Measure	Panel A: Mild Renal Impairment n=6 Participants Participants with an eGFR of \>50 to \<80 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel B: Healthy Controls to Panel A n=6 Participants Healthy control participants were matched specifically to participants in Panel A and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel C: Moderate Renal Impairment n=6 Participants Participants with an eGFR of 30 to 50 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel D: Healthy Controls to Panel C n=6 Participants Healthy control participants were matched specifically to participants in Panel C and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel E: Severe Renal Impairment n=6 Participants Participants with an eGFR \<30 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel F: Healthy Controls to Panel E n=6 Participants A subset of healthy control participants was matched specifically to participants in Panel E and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 1 Postdialysis n=6 Participants Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).	Panel H: Healthy Controls to Panel G n=6 Participants Healthy control participants were matched specifically to participants in Panel G and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 2 Predialysis n=6 Participants Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).
Part 1: Predicted Clearance (CLpred) of MK-7655 in Combination With PRIMAXIN®	81.3 mL/min Interval 55.3 to 119.0	133 mL/min Interval 95.5 to 185.0	52.1 mL/min Interval 36.2 to 74.9	114 mL/min Interval 82.3 to 159.0	25.3 mL/min Interval 18.4 to 34.9	123 mL/min Interval 90.0 to 169.0	14.4 mL/min Interval 9.77 to 21.3	135 mL/min Interval 88.1 to 206.0	76.6 mL/min Interval 49.4 to 119.0

SECONDARY outcome

Timeframe: Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose

Population: Treated participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, data for Panel G were reported separately for post-dialysis and pre-dialysis.

VZpred is the predicted volume of distribution during the terminal phase.

Outcome measures

Outcome measures
Measure	Panel A: Mild Renal Impairment n=6 Participants Participants with an eGFR of \>50 to \<80 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel B: Healthy Controls to Panel A n=6 Participants Healthy control participants were matched specifically to participants in Panel A and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel C: Moderate Renal Impairment n=6 Participants Participants with an eGFR of 30 to 50 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel D: Healthy Controls to Panel C n=6 Participants Healthy control participants were matched specifically to participants in Panel C and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel E: Severe Renal Impairment n=6 Participants Participants with an eGFR \<30 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel F: Healthy Controls to Panel E n=6 Participants A subset of healthy control participants was matched specifically to participants in Panel E and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 1 Postdialysis n=6 Participants Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).	Panel H: Healthy Controls to Panel G n=6 Participants Healthy control participants were matched specifically to participants in Panel G and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 2 Predialysis n=6 Participants Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).
Part 1: Predicted Volume of Distribution During the Terminal Phase (VZpred) of MK-7655 in Combination With PRIMAXIN®	21.4 liters (L) Interval 17.6 to 26.1	21.6 liters (L) Interval 18.2 to 25.5	22.2 liters (L) Interval 18.4 to 26.7	21.9 liters (L) Interval 18.5 to 25.9	20.1 liters (L) Interval 17.1 to 23.7	22.4 liters (L) Interval 19.0 to 26.3	16.2 liters (L) Interval 13.3 to 19.8	17.0 liters (L) Interval 13.6 to 21.1	55.7 liters (L) Interval 44.5 to 69.7

SECONDARY outcome

Timeframe: Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose

Population: Treated participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, data for Panel G were reported separately for post-dialysis and pre-dialysis.

Tmax is the time at which the highest plasma drug concentration was observed.

Outcome measures

Outcome measures
Measure	Panel A: Mild Renal Impairment n=6 Participants Participants with an eGFR of \>50 to \<80 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel B: Healthy Controls to Panel A n=6 Participants Healthy control participants were matched specifically to participants in Panel A and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel C: Moderate Renal Impairment n=6 Participants Participants with an eGFR of 30 to 50 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel D: Healthy Controls to Panel C n=6 Participants Healthy control participants were matched specifically to participants in Panel C and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel E: Severe Renal Impairment n=6 Participants Participants with an eGFR \<30 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel F: Healthy Controls to Panel E n=6 Participants A subset of healthy control participants was matched specifically to participants in Panel E and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 1 Postdialysis n=6 Participants Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).	Panel H: Healthy Controls to Panel G n=6 Participants Healthy control participants were matched specifically to participants in Panel G and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 2 Predialysis n=6 Participants Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).
Part 1: Time of Maximum Plasma Concentration (Tmax) of MK-7655 in Combination With PRIMAXIN®	0.50 hours Interval 0.48 to 1.27	0.50 hours Interval 0.48 to 0.52	0.50 hours Interval 0.48 to 0.75	0.49 hours Interval 0.48 to 0.75	0.48 hours Interval 0.48 to 1.0	0.48 hours Interval 0.48 to 0.75	0.48 hours Interval 0.08 to 1.0	0.48 hours Interval 0.48 to 0.48	0.48 hours Interval 0.48 to 0.55

SECONDARY outcome

Timeframe: Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose

Population: Treated participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, data for Panel G were reported separately for post-dialysis and pre-dialysis.

Apparent t½ is the amount of time for the maximum drug concentration to decrease by 50%.

Outcome measures

Outcome measures
Measure	Panel A: Mild Renal Impairment n=6 Participants Participants with an eGFR of \>50 to \<80 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel B: Healthy Controls to Panel A n=6 Participants Healthy control participants were matched specifically to participants in Panel A and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel C: Moderate Renal Impairment n=6 Participants Participants with an eGFR of 30 to 50 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel D: Healthy Controls to Panel C n=6 Participants Healthy control participants were matched specifically to participants in Panel C and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel E: Severe Renal Impairment n=6 Participants Participants with an eGFR \<30 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel F: Healthy Controls to Panel E n=6 Participants A subset of healthy control participants was matched specifically to participants in Panel E and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 1 Postdialysis n=6 Participants Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).	Panel H: Healthy Controls to Panel G n=6 Participants Healthy control participants were matched specifically to participants in Panel G and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 2 Predialysis n=6 Participants Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).
Part 1: Apparent Plasma Half-life (t½) of MK-7655 in Combination With PRIMAXIN®	2.63 hours Geometric Coefficient of Variation 26.4	1.75 hours Geometric Coefficient of Variation 16.6	4.51 hours Geometric Coefficient of Variation 25.7	2.10 hours Geometric Coefficient of Variation 31.0	8.65 hours Geometric Coefficient of Variation 31.0	2.00 hours Geometric Coefficient of Variation 10.4	15.6 hours Geometric Coefficient of Variation 103.1	1.79 hours Geometric Coefficient of Variation 13.9	10.5 hours Geometric Coefficient of Variation 100.6

SECONDARY outcome

Timeframe: Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose

Population: Treated participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, data for Panel G were reported separately for post-dialysis and pre-dialysis.

Imipenem is 1 of the 2 constituents of PRIMAXIN®. AUC0-∞ is a measure of the mean (extrapolated) plasma drug concentration after dosing to infinity.

Outcome measures

Outcome measures
Measure	Panel A: Mild Renal Impairment n=6 Participants Participants with an eGFR of \>50 to \<80 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel B: Healthy Controls to Panel A n=6 Participants Healthy control participants were matched specifically to participants in Panel A and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel C: Moderate Renal Impairment n=6 Participants Participants with an eGFR of 30 to 50 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel D: Healthy Controls to Panel C n=6 Participants Healthy control participants were matched specifically to participants in Panel C and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel E: Severe Renal Impairment n=6 Participants Participants with an eGFR \<30 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel F: Healthy Controls to Panel E n=6 Participants A subset of healthy control participants was matched specifically to participants in Panel E and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 1 Postdialysis n=6 Participants Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).	Panel H: Healthy Controls to Panel G n=6 Participants Healthy control participants were matched specifically to participants in Panel G and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 2 Predialysis n=6 Participants Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).
Part 1: AUC0-inf of Imipenem in Combination With MK-7655	77.3 µM*hr Interval 58.9 to 101.0	55.0 µM*hr Interval 43.5 to 69.5	101 µM*hr Interval 77.9 to 130.0	66.0 µM*hr Interval 52.2 to 83.3	160 µM*hr Interval 127.0 to 201.0	63.8 µM*hr Interval 51.0 to 79.9	223 µM*hr Interval 169.0 to 293.0	71.8 µM*hr Interval 53.4 to 96.5	71.2 µM*hr Interval 54.2 to 93.6

SECONDARY outcome

Timeframe: At 0.5 hours postdose

Population: Treated participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, data for Panel G were reported separately for post-dialysis and pre-dialysis.

Imipenem is 1 of the 2 constituents of PRIMAXIN®. Ceoi is the observed plasma drug concentration at the end of IV infusion.

Outcome measures

Outcome measures
Measure	Panel A: Mild Renal Impairment n=6 Participants Participants with an eGFR of \>50 to \<80 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel B: Healthy Controls to Panel A n=6 Participants Healthy control participants were matched specifically to participants in Panel A and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel C: Moderate Renal Impairment n=6 Participants Participants with an eGFR of 30 to 50 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel D: Healthy Controls to Panel C n=6 Participants Healthy control participants were matched specifically to participants in Panel C and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel E: Severe Renal Impairment n=6 Participants Participants with an eGFR \<30 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel F: Healthy Controls to Panel E n=6 Participants A subset of healthy control participants was matched specifically to participants in Panel E and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 1 Postdialysis n=8 Participants Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).	Panel H: Healthy Controls to Panel G n=6 Participants Healthy control participants were matched specifically to participants in Panel G and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 2 Predialysis n=6 Participants Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).
Part 1: Ceoi of Imipenem in Combination With MK-7655	40.7 µM Interval 22.7 to 73.2	35.3 µM Interval 21.3 to 58.5	45.6 µM Interval 26.2 to 79.5	42.6 µM Interval 25.8 to 70.4	46.9 µM Interval 28.7 to 76.5	35.5 µM Interval 21.9 to 57.6	103 µM Interval 57.1 to 186.0	41.8 µM Interval 22.1 to 79.1	35.9 µM Interval 19.9 to 64.7

SECONDARY outcome

Timeframe: Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose

Population: Treated participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, data for Panel G were reported separately for post-dialysis and pre-dialysis.

Imipenem is 1 of the 2 constituents of PRIMAXIN®. CLpred is the predicted apparent total body clearance of drug.

Outcome measures

Outcome measures
Measure	Panel A: Mild Renal Impairment n=6 Participants Participants with an eGFR of \>50 to \<80 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel B: Healthy Controls to Panel A n=6 Participants Healthy control participants were matched specifically to participants in Panel A and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel C: Moderate Renal Impairment n=6 Participants Participants with an eGFR of 30 to 50 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel D: Healthy Controls to Panel C n=6 Participants Healthy control participants were matched specifically to participants in Panel C and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel E: Severe Renal Impairment n=6 Participants Participants with an eGFR \<30 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel F: Healthy Controls to Panel E n=6 Participants A subset of healthy control participants was matched specifically to participants in Panel E and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 1 Postdialysis n=6 Participants Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).	Panel H: Healthy Controls to Panel G n=6 Participants Healthy control participants were matched specifically to participants in Panel G and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 2 Predialysis n=6 Participants Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).
Part 1: CLpred of Imipenem in Combination With MK-7655	180 mL/min Interval 137.0 to 236.0	253 mL/min Interval 200.0 to 320.0	138 mL/min Interval 107.0 to 179.0	211 mL/min Interval 167.0 to 266.0	87.0 mL/min Interval 69.4 to 109.0	218 mL/min Interval 174.0 to 273.0	62.5 mL/min Interval 47.5 to 82.1	194 mL/min Interval 144.0 to 261.0	195 mL/min Interval 149.0 to 257.0

SECONDARY outcome

Timeframe: Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose

Population: Treated participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, data for Panel G were reported separately for post-dialysis and pre-dialysis.

Imipenem is 1 of the 2 constituents of PRIMAXIN®. VZpred is the predicted volume of distribution during the terminal phase.

Outcome measures

Outcome measures
Measure	Panel A: Mild Renal Impairment n=6 Participants Participants with an eGFR of \>50 to \<80 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel B: Healthy Controls to Panel A n=6 Participants Healthy control participants were matched specifically to participants in Panel A and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel C: Moderate Renal Impairment n=6 Participants Participants with an eGFR of 30 to 50 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel D: Healthy Controls to Panel C n=6 Participants Healthy control participants were matched specifically to participants in Panel C and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel E: Severe Renal Impairment n=6 Participants Participants with an eGFR \<30 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel F: Healthy Controls to Panel E n=6 Participants A subset of healthy control participants was matched specifically to participants in Panel E and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 1 Postdialysis n=6 Participants Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).	Panel H: Healthy Controls to Panel G n=6 Participants Healthy control participants were matched specifically to participants in Panel G and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 2 Predialysis n=6 Participants Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).
Part 1: VZpred of Imipenem in Combination With MK-7655	21.1 liters (L) Interval 15.8 to 28.2	26.1 liters (L) Interval 20.4 to 33.5	22.3 liters (L) Interval 17.0 to 29.3	23.4 liters (L) Interval 18.3 to 30.0	20.0 liters (L) Interval 15.7 to 25.4	24.8 liters (L) Interval 19.6 to 31.5	20.5 liters (L) Interval 15.4 to 27.4	24.9 liters (L) Interval 18.2 to 34.1	63.3 liters (L) Interval 47.3 to 84.6

SECONDARY outcome

Timeframe: Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose

Population: Treated participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, data for Panel G were reported separately for post-dialysis and pre-dialysis.

Tmax is the time at which the highest plasma drug concentration was observed.

Outcome measures

Outcome measures
Measure	Panel A: Mild Renal Impairment n=6 Participants Participants with an eGFR of \>50 to \<80 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel B: Healthy Controls to Panel A n=6 Participants Healthy control participants were matched specifically to participants in Panel A and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel C: Moderate Renal Impairment n=6 Participants Participants with an eGFR of 30 to 50 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel D: Healthy Controls to Panel C n=6 Participants Healthy control participants were matched specifically to participants in Panel C and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel E: Severe Renal Impairment n=6 Participants Participants with an eGFR \<30 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel F: Healthy Controls to Panel E n=6 Participants A subset of healthy control participants was matched specifically to participants in Panel E and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 1 Postdialysis n=6 Participants Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).	Panel H: Healthy Controls to Panel G n=6 Participants Healthy control participants were matched specifically to participants in Panel G and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 2 Predialysis n=6 Participants Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).
Part 1: Tmax of Imipenem in Combination With MK-7655	0.50 hours Interval 0.48 to 0.82	0.50 hours Interval 0.48 to 0.52	0.49 hours Interval 0.48 to 0.5	0.48 hours Interval 0.48 to 0.52	0.48 hours Interval 0.48 to 1.0	0.48 hours Interval 0.48 to 0.75	0.48 hours Interval 0.08 to 0.48	0.48 hours Interval 0.48 to 0.48	0.48 hours Interval 0.48 to 0.55

SECONDARY outcome

Timeframe: Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose

Population: Treated participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, data for Panel G were reported separately for post-dialysis and pre-dialysis.

Imipenem is 1 of the 2 constituents of PRIMAXIN®. Apparent t½ is the amount of time for the maximum drug concentration to decrease by 50%.

Outcome measures

Outcome measures
Measure	Panel A: Mild Renal Impairment n=6 Participants Participants with an eGFR of \>50 to \<80 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel B: Healthy Controls to Panel A n=6 Participants Healthy control participants were matched specifically to participants in Panel A and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel C: Moderate Renal Impairment n=6 Participants Participants with an eGFR of 30 to 50 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel D: Healthy Controls to Panel C n=6 Participants Healthy control participants were matched specifically to participants in Panel C and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel E: Severe Renal Impairment n=6 Participants Participants with an eGFR \<30 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel F: Healthy Controls to Panel E n=6 Participants A subset of healthy control participants was matched specifically to participants in Panel E and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 1 Postdialysis n=6 Participants Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).	Panel H: Healthy Controls to Panel G n=6 Participants Healthy control participants were matched specifically to participants in Panel G and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 2 Predialysis n=6 Participants Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).
Part 1: Apparent t½ of Imipenem in Combination With MK-7655	1.54 hours Geometric Coefficient of Variation 15.2	1.24 hours Geometric Coefficient of Variation 10.8	2.18 hours Geometric Coefficient of Variation 12.8	1.40 hours Geometric Coefficient of Variation 21.1	2.78 hours Geometric Coefficient of Variation 11.9	1.32 hours Geometric Coefficient of Variation 5.8	3.24 hours Geometric Coefficient of Variation 18.7	1.21 hours Geometric Coefficient of Variation 13.7	3.20 hours Geometric Coefficient of Variation 47.8

SECONDARY outcome

Timeframe: Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose

Population: Treated participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, data for Panel G were reported separately for post-dialysis and pre-dialysis.

Cilastin is 1 of the 2 constituents of PRIMAXIN®. AUC0-∞ is a measure of the mean (extrapolated) plasma drug concentration after dosing to infinity.

Outcome measures

Outcome measures
Measure	Panel A: Mild Renal Impairment n=6 Participants Participants with an eGFR of \>50 to \<80 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel B: Healthy Controls to Panel A n=6 Participants Healthy control participants were matched specifically to participants in Panel A and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel C: Moderate Renal Impairment n=6 Participants Participants with an eGFR of 30 to 50 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel D: Healthy Controls to Panel C n=6 Participants Healthy control participants were matched specifically to participants in Panel C and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel E: Severe Renal Impairment n=6 Participants Participants with an eGFR \<30 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel F: Healthy Controls to Panel E n=6 Participants A subset of healthy control participants was matched specifically to participants in Panel E and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 1 Postdialysis n=6 Participants Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).	Panel H: Healthy Controls to Panel G n=6 Participants Healthy control participants were matched specifically to participants in Panel G and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 2 Predialysis n=6 Participants Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).
Part 1: AUC0-inf of Cilastin in Combination With MK-7655	71.7 µM*hr Interval 45.8 to 112.0	44.8 µM*hr Interval 30.5 to 65.9	100.0 µM*hr Interval 65.4 to 153.0	53.6 µM*hr Interval 36.6 to 78.6	300 µM*hr Interval 207.0 to 436.0	53.7 µM*hr Interval 37.2 to 77.6	777 µM*hr Interval 493.0 to 1220.0	56.5 µM*hr Interval 34.5 to 92.6	205 µM*hr Interval 123.0 to 343.0

SECONDARY outcome

Timeframe: At 0.5 hours postdose

Population: Treated participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, data for Panel G were reported separately for post-dialysis and pre-dialysis.

Cilastin is 1 of the 2 constituents of PRIMAXIN®. Ceoi is the observed plasma drug concentration at the end of IV infusion.

Outcome measures

Outcome measures
Measure	Panel A: Mild Renal Impairment n=6 Participants Participants with an eGFR of \>50 to \<80 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel B: Healthy Controls to Panel A n=6 Participants Healthy control participants were matched specifically to participants in Panel A and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel C: Moderate Renal Impairment n=6 Participants Participants with an eGFR of 30 to 50 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel D: Healthy Controls to Panel C n=6 Participants Healthy control participants were matched specifically to participants in Panel C and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel E: Severe Renal Impairment n=6 Participants Participants with an eGFR \<30 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel F: Healthy Controls to Panel E n=6 Participants A subset of healthy control participants was matched specifically to participants in Panel E and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 1 Postdialysis n=8 Participants Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).	Panel H: Healthy Controls to Panel G n=6 Participants Healthy control participants were matched specifically to participants in Panel G and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 2 Predialysis n=6 Participants Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).
Part 1: Ceoi of Cilastin in Combination With MK-7655	43.4 µM Interval 25.9 to 72.7	34.8 µM Interval 22.3 to 54.4	48.7 µM Interval 29.8 to 79.4	42.9 µM Interval 27.5 to 66.8	53.3 µM Interval 34.6 to 82.0	35.8 µM Interval 23.4 to 54.8	111 µM Interval 65.9 to 186.0	44.5 µM Interval 25.4 to 78.0	41.7 µM Interval 24.8 to 70.0

SECONDARY outcome

Timeframe: Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose

Population: Treated participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, data for Panel G were reported separately for post-dialysis and pre-dialysis.

Cilastin is 1 of the 2 constituents of PRIMAXIN®. CLpred is the predicted apparent total body clearance of drug.

Outcome measures

Outcome measures
Measure	Panel A: Mild Renal Impairment n=6 Participants Participants with an eGFR of \>50 to \<80 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel B: Healthy Controls to Panel A n=6 Participants Healthy control participants were matched specifically to participants in Panel A and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel C: Moderate Renal Impairment n=6 Participants Participants with an eGFR of 30 to 50 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel D: Healthy Controls to Panel C n=6 Participants Healthy control participants were matched specifically to participants in Panel C and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel E: Severe Renal Impairment n=6 Participants Participants with an eGFR \<30 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel F: Healthy Controls to Panel E n=6 Participants A subset of healthy control participants was matched specifically to participants in Panel E and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 1 Postdialysis n=6 Participants Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).	Panel H: Healthy Controls to Panel G n=6 Participants Healthy control participants were matched specifically to participants in Panel G and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 2 Predialysis n=6 Participants Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).
Part 1: CLpred of Cilastin in Combination With MK-7655	162 mL/min Interval 104.0 to 254.0	259 mL/min Interval 176.0 to 381.0	116 mL/min Interval 76.1 to 178.0	217 mL/min Interval 148.0 to 318.0	38.7 mL/min Interval 26.7 to 56.2	217 mL/min Interval 150.0 to 313.0	15.0 mL/min Interval 9.5 to 23.6	206 mL/min Interval 126.0 to 337.0	56.6 mL/min Interval 33.9 to 94.4

SECONDARY outcome

Timeframe: Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose

Population: Treated participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, data for Panel G were reported separately for post-dialysis and pre-dialysis.

Cilastin is 1 of the 2 constituents of PRIMAXIN®. VZpred is the predicted volume of distribution during the terminal phase.

Outcome measures

Outcome measures
Measure	Panel A: Mild Renal Impairment n=6 Participants Participants with an eGFR of \>50 to \<80 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel B: Healthy Controls to Panel A n=6 Participants Healthy control participants were matched specifically to participants in Panel A and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel C: Moderate Renal Impairment n=6 Participants Participants with an eGFR of 30 to 50 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel D: Healthy Controls to Panel C n=6 Participants Healthy control participants were matched specifically to participants in Panel C and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel E: Severe Renal Impairment n=6 Participants Participants with an eGFR \<30 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel F: Healthy Controls to Panel E n=6 Participants A subset of healthy control participants was matched specifically to participants in Panel E and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 1 Postdialysis n=6 Participants Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).	Panel H: Healthy Controls to Panel G n=6 Participants Healthy control participants were matched specifically to participants in Panel G and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 2 Predialysis n=6 Participants Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).
Part 1: VZpred of Cilastin in Combination With MK-7655	19.2 liters (L) Interval 14.8 to 24.9	23.9 liters (L) Interval 19.1 to 30.0	19.4 liters (L) Interval 15.2 to 24.9	21.4 liters (L) Interval 17.1 to 26.7	16.9 liters (L) Interval 13.6 to 21.0	21.2 liters (L) Interval 17.1 to 26.2	15.9 liters (L) Interval 12.2 to 20.7	21.0 liters (L) Interval 15.8 to 28.0	59.1 liters (L) Interval 43.9 to 79.6

SECONDARY outcome

Timeframe: Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose

Population: Treated participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, data for Panel G were reported separately for post-dialysis and pre-dialysis.

Tmax is the time at which the highest plasma drug concentration was observed.

Outcome measures

Outcome measures
Measure	Panel A: Mild Renal Impairment n=6 Participants Participants with an eGFR of \>50 to \<80 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel B: Healthy Controls to Panel A n=6 Participants Healthy control participants were matched specifically to participants in Panel A and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel C: Moderate Renal Impairment n=6 Participants Participants with an eGFR of 30 to 50 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel D: Healthy Controls to Panel C n=6 Participants Healthy control participants were matched specifically to participants in Panel C and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel E: Severe Renal Impairment n=6 Participants Participants with an eGFR \<30 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel F: Healthy Controls to Panel E n=6 Participants A subset of healthy control participants was matched specifically to participants in Panel E and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 1 Postdialysis n=6 Participants Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).	Panel H: Healthy Controls to Panel G n=6 Participants Healthy control participants were matched specifically to participants in Panel G and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 2 Predialysis n=6 Participants Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).
Part 1: Tmax of Cilastin in Combination With MK-7655	0.50 hours Interval 0.5 to 0.82	0.50 hours Interval 0.48 to 0.52	0.49 hours Interval 0.48 to 0.5	0.48 hours Interval 0.48 to 0.52	0.48 hours Interval 0.48 to 1.0	0.48 hours Interval 0.48 to 0.48	0.48 hours Interval 0.08 to 0.48	0.48 hours Interval 0.48 to 0.48	0.48 hours Interval 0.48 to 0.55

SECONDARY outcome

Timeframe: Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose

Population: Treated participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, data for Panel G were reported separately for post-dialysis and pre-dialysis.

Cilastin is 1 of the 2 constituents of PRIMAXIN®. Apparent t½ is the amount of time for the maximum drug concentration to decrease by 50%.

Outcome measures

Outcome measures
Measure	Panel A: Mild Renal Impairment n=6 Participants Participants with an eGFR of \>50 to \<80 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel B: Healthy Controls to Panel A n=6 Participants Healthy control participants were matched specifically to participants in Panel A and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel C: Moderate Renal Impairment n=6 Participants Participants with an eGFR of 30 to 50 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel D: Healthy Controls to Panel C n=6 Participants Healthy control participants were matched specifically to participants in Panel C and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel E: Severe Renal Impairment n=6 Participants Participants with an eGFR \<30 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel F: Healthy Controls to Panel E n=6 Participants A subset of healthy control participants was matched specifically to participants in Panel E and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 1 Postdialysis n=6 Participants Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).	Panel H: Healthy Controls to Panel G n=6 Participants Healthy control participants were matched specifically to participants in Panel G and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 2 Predialysis n=6 Participants Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).
Part 1: Apparent t½ of Cilastin in Combination With MK-7655	1.43 hours Geometric Coefficient of Variation 31.9	1.08 hours Geometric Coefficient of Variation 27.8	2.11 hours Geometric Coefficient of Variation 20.5	1.19 hours Geometric Coefficient of Variation 28.5	5.08 hours Geometric Coefficient of Variation 59.2	1.09 hours Geometric Coefficient of Variation 10.7	12.2 hours Geometric Coefficient of Variation 118.5	1.14 hours Geometric Coefficient of Variation 26.1	12.2 hours Geometric Coefficient of Variation 131.5

SECONDARY outcome

Timeframe: Predose to 24 hours postdose

Population: Treated participants with urine samples who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, Panel G was not sampled due to limitations in producing urine and was thus not included in the analysis.

CLR represents renal clearance in urine. Urine was collected for 24 hours postdose.

Outcome measures

Outcome measures
Measure	Panel A: Mild Renal Impairment n=6 Participants Participants with an eGFR of \>50 to \<80 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel B: Healthy Controls to Panel A n=6 Participants Healthy control participants were matched specifically to participants in Panel A and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel C: Moderate Renal Impairment n=6 Participants Participants with an eGFR of 30 to 50 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel D: Healthy Controls to Panel C n=6 Participants Healthy control participants were matched specifically to participants in Panel C and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel E: Severe Renal Impairment n=6 Participants Participants with an eGFR \<30 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel F: Healthy Controls to Panel E n=6 Participants A subset of healthy control participants was matched specifically to participants in Panel E and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 1 Postdialysis n=6 Participants Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).	Panel H: Healthy Controls to Panel G Healthy control participants were matched specifically to participants in Panel G and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 2 Predialysis Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).
Part 1: Renal Clearance (CLR) of MK-7655 in Urine	69.8 mL/min Geometric Coefficient of Variation 16.5	118 mL/min Geometric Coefficient of Variation 19.8	38.4 mL/min Geometric Coefficient of Variation 28.8	110 mL/min Geometric Coefficient of Variation 36	22.3 mL/min Geometric Coefficient of Variation 47.2	107 mL/min Geometric Coefficient of Variation 20.9	110 mL/min Geometric Coefficient of Variation 20	—	—

SECONDARY outcome

Timeframe: Predose to 24 hours postdose

Population: Treated participants with urine samples who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, Panel G was not sampled due to limitations in producing urine and was thus not included in the analysis.

CLR represents renal clearance in urine. Urine was collected for 24 hours postdose.

Outcome measures

Outcome measures
Measure	Panel A: Mild Renal Impairment n=6 Participants Participants with an eGFR of \>50 to \<80 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel B: Healthy Controls to Panel A n=6 Participants Healthy control participants were matched specifically to participants in Panel A and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel C: Moderate Renal Impairment n=6 Participants Participants with an eGFR of 30 to 50 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel D: Healthy Controls to Panel C n=6 Participants Healthy control participants were matched specifically to participants in Panel C and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel E: Severe Renal Impairment n=6 Participants Participants with an eGFR \<30 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel F: Healthy Controls to Panel E n=6 Participants A subset of healthy control participants was matched specifically to participants in Panel E and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 1 Postdialysis n=6 Participants Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).	Panel H: Healthy Controls to Panel G Healthy control participants were matched specifically to participants in Panel G and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 2 Predialysis Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).
Part 1: CLR of Imipenem in Urine	75.0 mL/min Geometric Coefficient of Variation 14.6	115 mL/min Geometric Coefficient of Variation 18.4	41.1 mL/min Geometric Coefficient of Variation 23.8	109 mL/min Geometric Coefficient of Variation 29.2	17.4 mL/min Geometric Coefficient of Variation 44.7	104 mL/min Geometric Coefficient of Variation 10.5	99.1 mL/min Geometric Coefficient of Variation 22.3	—	—

SECONDARY outcome

Timeframe: Predose to 24 hours postdose

Population: Treated participants with urine samples who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, Panel G was not sampled due to limitations in producing urine and was thus not included in the analysis.

CLR represents renal clearance in urine. Urine was collected for 24 hours postdose.

Outcome measures

Outcome measures
Measure	Panel A: Mild Renal Impairment n=6 Participants Participants with an eGFR of \>50 to \<80 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel B: Healthy Controls to Panel A n=6 Participants Healthy control participants were matched specifically to participants in Panel A and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel C: Moderate Renal Impairment n=6 Participants Participants with an eGFR of 30 to 50 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel D: Healthy Controls to Panel C n=6 Participants Healthy control participants were matched specifically to participants in Panel C and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel E: Severe Renal Impairment n=6 Participants Participants with an eGFR \<30 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel F: Healthy Controls to Panel E n=6 Participants A subset of healthy control participants was matched specifically to participants in Panel E and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 1 Postdialysis n=6 Participants Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).	Panel H: Healthy Controls to Panel G Healthy control participants were matched specifically to participants in Panel G and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 2 Predialysis Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).
Part 1: CLR of Cilastin in Urine	99.4 mL/min Geometric Coefficient of Variation 29.1	144 mL/min Geometric Coefficient of Variation 21.9	59.6 mL/min Geometric Coefficient of Variation 29.4	136 mL/min Geometric Coefficient of Variation 23.9	24.5 mL/min Geometric Coefficient of Variation 50.5	140 mL/min Geometric Coefficient of Variation 24.4	146 mL/min Geometric Coefficient of Variation 18.6	—	—

SECONDARY outcome

Timeframe: Predose and 0.5, 1, 2,3, 4, 8, 12, and 24 hours postdose

Population: Treated participants with severe renal deficiency or ESRD and their matched controls (Panels E-H) who complied with the protocol enough to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, Panels A-D were not included in the analysis.

Caffeine was selected as a substrate of CYP1A2. AUC0-∞ was determined in participants with severe renal impairment and ESRD/HD participants.

Outcome measures

Outcome measures
Measure	Panel A: Mild Renal Impairment n=6 Participants Participants with an eGFR of \>50 to \<80 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel B: Healthy Controls to Panel A n=6 Participants Healthy control participants were matched specifically to participants in Panel A and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel C: Moderate Renal Impairment n=6 Participants Participants with an eGFR of 30 to 50 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel D: Healthy Controls to Panel C n=6 Participants Healthy control participants were matched specifically to participants in Panel C and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel E: Severe Renal Impairment n=6 Participants Participants with an eGFR \<30 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel F: Healthy Controls to Panel E A subset of healthy control participants was matched specifically to participants in Panel E and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 1 Postdialysis Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).	Panel H: Healthy Controls to Panel G Healthy control participants were matched specifically to participants in Panel G and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 2 Predialysis Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).
Part 2: Plasma AUC0-∞ of Caffeine as a Probe Substrate of Cytochrome P450 Enzyme (CYP)1A2	336 µM*hr Interval 232.0 to 489.0	221 µM*hr Interval 156.0 to 314.0	190 µM*hr Interval 138.0 to 264.0	200 µM*hr Interval 144.0 to 277.0	300 µM*hr Interval 211.0 to 427.0	—	—	—	—

SECONDARY outcome

Timeframe: Predose and 0.5, 1, 2,3, 4, 8, 12, and 24 hours postdose

Population: Treated participants with severe renal deficiency or ESRD and their matched controls (Panels E-H) who complied with the protocol enough to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, Panels A-D were not included in the analysis.

Midazolam was selected as a substrate of CYP3A4. AUC0-∞ was determined in participants with severe renal impairment and ESRD/HD participants.

Outcome measures

Outcome measures
Measure	Panel A: Mild Renal Impairment n=6 Participants Participants with an eGFR of \>50 to \<80 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel B: Healthy Controls to Panel A n=6 Participants Healthy control participants were matched specifically to participants in Panel A and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel C: Moderate Renal Impairment n=6 Participants Participants with an eGFR of 30 to 50 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel D: Healthy Controls to Panel C n=6 Participants Healthy control participants were matched specifically to participants in Panel C and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel E: Severe Renal Impairment n=6 Participants Participants with an eGFR \<30 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel F: Healthy Controls to Panel E A subset of healthy control participants was matched specifically to participants in Panel E and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 1 Postdialysis Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).	Panel H: Healthy Controls to Panel G Healthy control participants were matched specifically to participants in Panel G and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 2 Predialysis Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).
Part 2: Plasma AUC0-∞ of Midazolam as a Probe Substrate of Cytochrome P450 Enzyme (CYP)3A4	0.130 µM*hr Interval 0.073 to 0.23	0.121 µM*hr Interval 0.0707 to 0.207	0.0681 µM*hr Interval 0.0413 to 0.112	0.0700 µM*hr Interval 0.0425 to 0.115	0.114 µM*hr Interval 0.0664 to 0.197	—	—	—	—

SECONDARY outcome

Timeframe: Predose and 0.5, 1, 2,3, 4, 8, 12, and 24 hours postdose

Population: Treated participants with severe renal deficiency or ESRD and their matched controls (Panels E-H) who complied with the protocol enough to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included. Per protocol, Panels A-D were not included in the analysis.

Omeprazole was selected as a substrate of CYP2C19. AUC0-∞ was determined in participants with severe renal impairment and ESRD/HD participants.

Outcome measures

Outcome measures
Measure	Panel A: Mild Renal Impairment n=4 Participants Participants with an eGFR of \>50 to \<80 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel B: Healthy Controls to Panel A n=6 Participants Healthy control participants were matched specifically to participants in Panel A and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel C: Moderate Renal Impairment n=4 Participants Participants with an eGFR of 30 to 50 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel D: Healthy Controls to Panel C n=6 Participants Healthy control participants were matched specifically to participants in Panel C and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel E: Severe Renal Impairment n=5 Participants Participants with an eGFR \<30 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel F: Healthy Controls to Panel E A subset of healthy control participants was matched specifically to participants in Panel E and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 1 Postdialysis Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).	Panel H: Healthy Controls to Panel G Healthy control participants were matched specifically to participants in Panel G and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 2 Predialysis Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).
Part 2: Plasma AUC0-∞ of Omeprazole as a Probe Substrate of Cytochrome P450 Enzyme (CYP)2C19	9.10 µM*hr Interval 3.34 to 24.8	6.20 µM*hr Interval 2.85 to 13.5	4.56 µM*hr Interval 2.16 to 9.59	4.08 µM*hr Interval 1.97 to 8.44	5.03 µM*hr Interval 2.18 to 11.6	—	—	—	—

SECONDARY outcome

Timeframe: Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks)

Population: All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis.

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

Outcome measures

Outcome measures
Measure	Panel A: Mild Renal Impairment n=7 Participants Participants with an eGFR of \>50 to \<80 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel B: Healthy Controls to Panel A n=6 Participants Healthy control participants were matched specifically to participants in Panel A and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel C: Moderate Renal Impairment n=6 Participants Participants with an eGFR of 30 to 50 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel D: Healthy Controls to Panel C n=6 Participants Healthy control participants were matched specifically to participants in Panel C and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel E: Severe Renal Impairment n=24 Participants Participants with an eGFR \<30 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel F: Healthy Controls to Panel E n=6 Participants A subset of healthy control participants was matched specifically to participants in Panel E and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 1 Postdialysis n=6 Participants Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).	Panel H: Healthy Controls to Panel G n=12 Participants Healthy control participants were matched specifically to participants in Panel G and received a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel G: ESRD/HD Period 2 Predialysis Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2).
Parts 1 and 2: Percentage of Participants With ≥1 Adverse Events (AEs)	28.6 Percentage of Participants	16.7 Percentage of Participants	16.7 Percentage of Participants	33.3 Percentage of Participants	0.0 Percentage of Participants	33.3 Percentage of Participants	33.3 Percentage of Participants	0.0 Percentage of Participants	—

Adverse Events

Panel A: Mild Renal Impairment

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Panel C: Moderate Renal Impairment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Panel E: Severe Renal Impairment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Panel G: ESRD/HD Participants

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Healthy Matched Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Panel E: Severe Renal Impairment (Part 2)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Panel G: ESRD/HC (Part 2)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Healthy Matched Controls (Part 2)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Panel A: Mild Renal Impairment n=7 participants at risk Participants with an eGFR of \>50 to \<80 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel C: Moderate Renal Impairment n=6 participants at risk Participants with an eGFR of 30 to 50 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.	Panel E: Severe Renal Impairment n=6 participants at risk Participants with an eGFR \<30 mL/min/1.73m² receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1. In Part 2, participants receive an oral cocktail containing caffeine 200 mg, midazolam 2 mg, and omeprazole 40 mg.	Panel G: ESRD/HD Participants n=6 participants at risk Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2). In Part 2, participants receive an oral cocktail containing caffeine 200 mg, midazolam 2 mg, and omeprazole 40 mg predialysis (Part 2, Period 1) and postdialysis (Part 2, Period 2).	Healthy Matched Controls n=24 participants at risk Healthy matched controls receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1. For AE reporting, all healthy control participants in Part 1 are pooled into a single arm.	Panel E: Severe Renal Impairment (Part 2) n=6 participants at risk Participants with an eGFR \<30 mL/min/1.73m² receive an oral cocktail containing caffeine 200 mg, midazolam 2 mg, and omeprazole 40 mg.	Panel G: ESRD/HC (Part 2) n=6 participants at risk Participants with ESRD/HD receive an oral cocktail containing caffeine 200 mg, midazolam 2 mg, and omeprazole 40 mg.	Healthy Matched Controls (Part 2) n=12 participants at risk Healthy matched controls receive an oral cocktail containing caffeine 200 mg, midazolam 2 mg, and omeprazole 40 mg in Part 2. For AE reporting, all healthy control participants in Part 2 are pooled into a single arm.
Blood and lymphatic system disorders Anaemia	0.00% 0/7 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/24 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	16.7% 1/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/12 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.
Gastrointestinal disorders Abdominal pain	0.00% 0/7 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	16.7% 1/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/24 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/12 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.
Gastrointestinal disorders Diarrhoea	0.00% 0/7 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/24 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	16.7% 1/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/12 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.
Gastrointestinal disorders Nausea	0.00% 0/7 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/24 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	16.7% 1/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/12 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.
General disorders Infusion site swelling	14.3% 1/7 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/24 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/12 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.
Investigations Alanine aminotransferase increased	0.00% 0/7 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/24 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	16.7% 1/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/12 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.
Investigations Aspartate aminotransferase increased	0.00% 0/7 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/24 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	16.7% 1/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/12 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/7 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	16.7% 1/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/24 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/12 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.00% 0/7 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	16.7% 1/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/24 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/12 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/7 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/24 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	16.7% 1/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/12 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/7 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/24 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	16.7% 1/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/12 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/7 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/24 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	16.7% 1/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/12 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/7 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/24 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	16.7% 1/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/12 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/7 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/24 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	16.7% 1/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/12 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.
Nervous system disorders Headache	14.3% 1/7 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	16.7% 1/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/24 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	16.7% 1/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/12 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.
Nervous system disorders Somnolence	0.00% 0/7 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/24 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	16.7% 1/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/6 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.	0.00% 0/12 • Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks) All enrolled participants are included in the safety analysis according to the treatment received. Per protocol, healthy matched controls were pooled for the purpose of the safety analysis. AEs were reported separately for Panels E, G, and matching controls during Parts 1 and 2.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

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.
Publication restrictions are in place

Restriction type: OTHER