Trial Outcomes & Findings for Single Dose Study of MK-2060 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Older Japanese Participants on Dialysis (MK-2060-012) (NCT NCT05769595)

NCT ID: NCT05769595

Last Updated: 2025-03-14

Results Overview

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The number of participants who experienced an AE is reported.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 17 participants
• Primary outcome timeframe: Up to approximately 164 days
• Results posted on: 2025-03-14

Participant Flow

Participant milestones

Measure	MK-2060 Participants received MK-2060 50 mg via a single intravenous (IV) infusion over 60 minutes.	Placebo Participants received a single IV saline infusion over 60 minutes.
Overall Study STARTED	12	5
Overall Study COMPLETED	12	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Single Dose Study of MK-2060 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Older Japanese Participants on Dialysis (MK-2060-012)

Baseline characteristics by cohort

Measure	MK-2060 n=12 Participants Participants received MK-2060 50 mg via a single intravenous (IV) infusion over 60 minutes.	Placebo n=5 Participants Participants received a single IV saline infusion over 60 minutes.	Total n=17 Participants Total of all reporting groups
Age, Continuous	70.2 Years STANDARD_DEVIATION 7.2 • n=5 Participants	66.2 Years STANDARD_DEVIATION 8.3 • n=7 Participants	69.0 Years STANDARD_DEVIATION 7.5 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	4 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	5 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	12 Participants n=5 Participants	5 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 164 days

Population: All participants who received at least one dose of treatment.

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The number of participants who experienced an AE is reported.

Outcome measures

Measure	MK-2060 n=12 Participants Participants received MK-2060 50 mg via a single IV infusion over 60 minutes.	Placebo n=5 Participants Participants received a single IV saline infusion over 60 minutes.
Number of Participants Who Experienced an Adverse Event (AE)	10 Participants	4 Participants

PRIMARY outcome

Timeframe: Up to approximately 164 days

Population: All participants who received at least one dose of treatment

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The number of participants who discontinued study due to an AE is reported.

Outcome measures

Measure	MK-2060 n=12 Participants Participants received MK-2060 50 mg via a single IV infusion over 60 minutes.	Placebo n=5 Participants Participants received a single IV saline infusion over 60 minutes.
Number of Participants Who Discontinued Study Due to an AE	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis

Population: All participants who were compliant with the study procedures and have available data from at least one MK-2060 treatment were included.

Blood samples were collected at specified intervals for the determination of AUC0-inf. AUC0-inf is defined as the area under the concentration-time curve of MK-2060 from time zero to infinity.

Outcome measures

Measure	MK-2060 n=12 Participants Participants received MK-2060 50 mg via a single IV infusion over 60 minutes.	Placebo Participants received a single IV saline infusion over 60 minutes.
Area Under the Concentration-Time Curve of MK-2060 From Time 0 to Infinity (AUC 0-inf)	35000 hours*nmol/L Geometric Coefficient of Variation 31.8	—

SECONDARY outcome

Timeframe: Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis

Population: All participants who were compliant with the study procedures and have available data from at least one MK-2060 treatment were included.

Blood samples were collected at specified intervals for the determination of AUC0-last. AUC0-last is defined as the area under the plasma concentration-time curve from time zero to time of last measurable concentration of MK-2060.

Outcome measures

Measure	MK-2060 n=12 Participants Participants received MK-2060 50 mg via a single IV infusion over 60 minutes.	Placebo Participants received a single IV saline infusion over 60 minutes.
Area Under the Plasma Concentration-Time Curve of MK-2060 From Time 0 to Last (AUC0-last)	34500 hours*nmol/L Geometric Coefficient of Variation 31.8	—

SECONDARY outcome

Timeframe: Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis

Population: All participants who were compliant with the study procedures and have available data from at least one MK-2060 treatment were included.

Blood samples were collected at specified intervals for the determination of AUC0-168. AUC0-168 is defined as the area under the concentration-time curve of MK-2060 from time zero to 168 hours.

Outcome measures

Measure	MK-2060 n=12 Participants Participants received MK-2060 50 mg via a single IV infusion over 60 minutes.	Placebo Participants received a single IV saline infusion over 60 minutes.
Area Under the Concentration-Time Curve of MK-2060 From Time 0 to 168 Hours Postdose (AUC0-168)	10100 hours*nmol/L Geometric Coefficient of Variation 23.4	—

SECONDARY outcome

Timeframe: Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis

Population: All participants who were compliant with the study procedures and have available data from at least one MK-2060 treatment were included.

Blood samples were collected at specified intervals for the determination of Cmax. Cmax is defined as the maximum concentration of MK-2060 reached.

Outcome measures

Measure	MK-2060 n=12 Participants Participants received MK-2060 50 mg via a single IV infusion over 60 minutes.	Placebo Participants received a single IV saline infusion over 60 minutes.
Maximum Concentration (Cmax) of MK-2060	110 nmol/L Geometric Coefficient of Variation 26.0	—

SECONDARY outcome

Timeframe: Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis

Population: All participants who were compliant with the study procedures and have available data from at least one MK-2060 treatment were included.

Blood samples were collected at specified intervals for the determination of C168. C168 is defined as the maximum concentration of MK-2060 reached at 168 hours postdose.

Outcome measures

Measure	MK-2060 n=12 Participants Participants received MK-2060 50 mg via a single IV infusion over 60 minutes.	Placebo Participants received a single IV saline infusion over 60 minutes.
Concentration at 168 Hours (C168) Postdose of MK-2060	39.0 nmol/L Geometric Coefficient of Variation 30.9	—

SECONDARY outcome

Timeframe: Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis

Population: All participants who were compliant with the study procedures and have available data from at least one MK-2060 treatment were included.

Blood samples were collected at specified intervals for the determination of Tmax. Tmax is defined as time to the maximum concentration of MK-2060 reached.

Outcome measures

Measure	MK-2060 n=12 Participants Participants received MK-2060 50 mg via a single IV infusion over 60 minutes.	Placebo Participants received a single IV saline infusion over 60 minutes.
Time to Maximum Concentration (Tmax) of MK-2060	1.03 hours Interval 0.88 to 12.02	—

SECONDARY outcome

Timeframe: Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis

Population: All participants who were compliant with the study procedures and have available data from at least one MK-2060 treatment were included.

Blood samples were collected at specified intervals for the determination of Tlast. Tlast is defined as the time to the last measurable concentration of MK-2060 reached.

Outcome measures

Measure	MK-2060 n=12 Participants Participants received MK-2060 50 mg via a single IV infusion over 60 minutes.	Placebo Participants received a single IV saline infusion over 60 minutes.
Time of the Last Measurable Plasma Concentration (Tlast) of MK-2060	3407.34 hours Interval 2186.65 to 3695.18	—

SECONDARY outcome

Timeframe: Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis

Population: All participants who were compliant with the study procedures and have available data from at least one MK-2060 treatment were included.

Blood samples were collected at specified intervals for the determination of t½. t½ is defined as the time required to divide the MK-2060 plasma concentration by two after reaching pseudo-equilibrium, following a single dose of MK-2060.

Outcome measures

Measure	MK-2060 n=12 Participants Participants received MK-2060 50 mg via a single IV infusion over 60 minutes.	Placebo Participants received a single IV saline infusion over 60 minutes.
Terminal Half-Life (t ½) of MK-2060	22.7 Days Geometric Coefficient of Variation 18.2	—

SECONDARY outcome

Timeframe: Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis

Population: All participants who were compliant with the study procedures and have available data from at least one MK-2060 treatment were included.

Blood samples were collected at specified intervals for the determination of CL. CL is the volume of plasma from which the study drug is completely removed per unit time.

Outcome measures

Measure	MK-2060 n=12 Participants Participants received MK-2060 50 mg via a single IV infusion over 60 minutes.	Placebo Participants received a single IV saline infusion over 60 minutes.
Clearance (CL) of MK-2060	0.00964 Liters/hour Geometric Coefficient of Variation 31.8	—

SECONDARY outcome

Timeframe: Predose, 1, 12, 24, 48 and 52 hours postdose; 5, 12, 15, 22, 60, 90, and up to 157 days post dose; and twice daily on Days 8, 29, 120: pre- and post-dialysis

Population: All participants who were compliant with the study procedures and have available data from at least one MK-2060 treatment were included.

Blood samples were collected at specified intervals for the determination of Vz. Vz is the apparent volume of distribution during the terminal phase.

Outcome measures

Measure	MK-2060 n=12 Participants Participants received MK-2060 50 mg via a single IV infusion over 60 minutes.	Placebo Participants received a single IV saline infusion over 60 minutes.
Volume of Distribution (Vz) of MK-2060	7.58 Liters Geometric Coefficient of Variation 28.5	—

SECONDARY outcome

Timeframe: Baseline and 168 hours post dose

Population: All participants who were compliant with the study procedures and have available data from at least one treatment were included.

Blood samples were collected for the determination of aPTT. Change from baseline in aPTT up to 168 hours post dose (pre dialysis) is reported.

Outcome measures

Measure	MK-2060 n=12 Participants Participants received MK-2060 50 mg via a single IV infusion over 60 minutes.	Placebo n=5 Participants Participants received a single IV saline infusion over 60 minutes.
Change From Baseline in Activated Partial Thromboplastin Time (aPTT)	2.45 Fold-Change from baseline Interval 2.27 to 2.63	0.97 Fold-Change from baseline Interval 0.87 to 1.09

Adverse Events

MK-2060 50 mg

Serious events: 3 serious events

Other events: 9 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	MK-2060 50 mg n=12 participants at risk Participants received MK-2060 50 mg via a single intravenous (IV) infusion over 60 minutes.	Placebo n=5 participants at risk Participants received a single IV saline infusion over 60 minutes.
Gastrointestinal disorders Mechanical ileus	0.00% 0/12 • Up to approximately 164 days All participants who received at least one dose of treatment.	20.0% 1/5 • Number of events 1 • Up to approximately 164 days All participants who received at least one dose of treatment.
Infections and infestations Enteritis infectious	8.3% 1/12 • Number of events 1 • Up to approximately 164 days All participants who received at least one dose of treatment.	0.00% 0/5 • Up to approximately 164 days All participants who received at least one dose of treatment.
Injury, poisoning and procedural complications Shunt occlusion	8.3% 1/12 • Number of events 1 • Up to approximately 164 days All participants who received at least one dose of treatment.	0.00% 0/5 • Up to approximately 164 days All participants who received at least one dose of treatment.
Injury, poisoning and procedural complications Shunt stenosis	8.3% 1/12 • Number of events 1 • Up to approximately 164 days All participants who received at least one dose of treatment.	0.00% 0/5 • Up to approximately 164 days All participants who received at least one dose of treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	8.3% 1/12 • Number of events 1 • Up to approximately 164 days All participants who received at least one dose of treatment.	0.00% 0/5 • Up to approximately 164 days All participants who received at least one dose of treatment.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/12 • Up to approximately 164 days All participants who received at least one dose of treatment.	20.0% 1/5 • Number of events 1 • Up to approximately 164 days All participants who received at least one dose of treatment.

Other adverse events

Measure	MK-2060 50 mg n=12 participants at risk Participants received MK-2060 50 mg via a single intravenous (IV) infusion over 60 minutes.	Placebo n=5 participants at risk Participants received a single IV saline infusion over 60 minutes.
Blood and lymphatic system disorders Nephrogenic anaemia	8.3% 1/12 • Number of events 1 • Up to approximately 164 days All participants who received at least one dose of treatment.	0.00% 0/5 • Up to approximately 164 days All participants who received at least one dose of treatment.
Gastrointestinal disorders Diarrhoea	8.3% 1/12 • Number of events 3 • Up to approximately 164 days All participants who received at least one dose of treatment.	0.00% 0/5 • Up to approximately 164 days All participants who received at least one dose of treatment.
Gastrointestinal disorders Duodenitis	0.00% 0/12 • Up to approximately 164 days All participants who received at least one dose of treatment.	20.0% 1/5 • Number of events 1 • Up to approximately 164 days All participants who received at least one dose of treatment.
Gastrointestinal disorders Toothache	8.3% 1/12 • Number of events 1 • Up to approximately 164 days All participants who received at least one dose of treatment.	0.00% 0/5 • Up to approximately 164 days All participants who received at least one dose of treatment.
Gastrointestinal disorders Vomiting	16.7% 2/12 • Number of events 4 • Up to approximately 164 days All participants who received at least one dose of treatment.	0.00% 0/5 • Up to approximately 164 days All participants who received at least one dose of treatment.
General disorders Oedema peripheral	8.3% 1/12 • Number of events 1 • Up to approximately 164 days All participants who received at least one dose of treatment.	20.0% 1/5 • Number of events 1 • Up to approximately 164 days All participants who received at least one dose of treatment.
General disorders Pyrexia	0.00% 0/12 • Up to approximately 164 days All participants who received at least one dose of treatment.	20.0% 1/5 • Number of events 1 • Up to approximately 164 days All participants who received at least one dose of treatment.
General disorders Vaccination site pain	8.3% 1/12 • Number of events 1 • Up to approximately 164 days All participants who received at least one dose of treatment.	0.00% 0/5 • Up to approximately 164 days All participants who received at least one dose of treatment.
Infections and infestations COVID-19	8.3% 1/12 • Number of events 2 • Up to approximately 164 days All participants who received at least one dose of treatment.	0.00% 0/5 • Up to approximately 164 days All participants who received at least one dose of treatment.
Infections and infestations Nasopharyngitis	16.7% 2/12 • Number of events 2 • Up to approximately 164 days All participants who received at least one dose of treatment.	20.0% 1/5 • Number of events 1 • Up to approximately 164 days All participants who received at least one dose of treatment.
Injury, poisoning and procedural complications Contusion	16.7% 2/12 • Number of events 2 • Up to approximately 164 days All participants who received at least one dose of treatment.	0.00% 0/5 • Up to approximately 164 days All participants who received at least one dose of treatment.
Injury, poisoning and procedural complications Immunisation reaction	8.3% 1/12 • Number of events 1 • Up to approximately 164 days All participants who received at least one dose of treatment.	20.0% 1/5 • Number of events 1 • Up to approximately 164 days All participants who received at least one dose of treatment.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/12 • Up to approximately 164 days All participants who received at least one dose of treatment.	20.0% 1/5 • Number of events 1 • Up to approximately 164 days All participants who received at least one dose of treatment.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/12 • Up to approximately 164 days All participants who received at least one dose of treatment.	20.0% 1/5 • Number of events 1 • Up to approximately 164 days All participants who received at least one dose of treatment.
Injury, poisoning and procedural complications Shunt stenosis	16.7% 2/12 • Number of events 3 • Up to approximately 164 days All participants who received at least one dose of treatment.	0.00% 0/5 • Up to approximately 164 days All participants who received at least one dose of treatment.
Investigations Bleeding time prolonged	8.3% 1/12 • Number of events 1 • Up to approximately 164 days All participants who received at least one dose of treatment.	0.00% 0/5 • Up to approximately 164 days All participants who received at least one dose of treatment.
Investigations Electrocardiogram QT prolonged	8.3% 1/12 • Number of events 1 • Up to approximately 164 days All participants who received at least one dose of treatment.	0.00% 0/5 • Up to approximately 164 days All participants who received at least one dose of treatment.
Investigations Occult blood positive	16.7% 2/12 • Number of events 2 • Up to approximately 164 days All participants who received at least one dose of treatment.	0.00% 0/5 • Up to approximately 164 days All participants who received at least one dose of treatment.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/12 • Up to approximately 164 days All participants who received at least one dose of treatment.	20.0% 1/5 • Number of events 1 • Up to approximately 164 days All participants who received at least one dose of treatment.
Musculoskeletal and connective tissue disorders Back pain	8.3% 1/12 • Number of events 1 • Up to approximately 164 days All participants who received at least one dose of treatment.	0.00% 0/5 • Up to approximately 164 days All participants who received at least one dose of treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal papillary mucinous neoplasm	0.00% 0/12 • Up to approximately 164 days All participants who received at least one dose of treatment.	20.0% 1/5 • Number of events 1 • Up to approximately 164 days All participants who received at least one dose of treatment.
Renal and urinary disorders Haematuria	0.00% 0/12 • Up to approximately 164 days All participants who received at least one dose of treatment.	20.0% 1/5 • Number of events 1 • Up to approximately 164 days All participants who received at least one dose of treatment.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/12 • Up to approximately 164 days All participants who received at least one dose of treatment.	20.0% 1/5 • Number of events 1 • Up to approximately 164 days All participants who received at least one dose of treatment.
Skin and subcutaneous tissue disorders Dermatitis contact	8.3% 1/12 • Number of events 1 • Up to approximately 164 days All participants who received at least one dose of treatment.	0.00% 0/5 • Up to approximately 164 days All participants who received at least one dose of treatment.
Skin and subcutaneous tissue disorders Pruritus allergic	0.00% 0/12 • Up to approximately 164 days All participants who received at least one dose of treatment.	20.0% 1/5 • Number of events 1 • Up to approximately 164 days All participants who received at least one dose of treatment.
Vascular disorders Hypotension	0.00% 0/12 • Up to approximately 164 days All participants who received at least one dose of treatment.	20.0% 1/5 • Number of events 2 • Up to approximately 164 days All participants who received at least one dose of treatment.
Vascular disorders Internal haemorrhage	0.00% 0/12 • Up to approximately 164 days All participants who received at least one dose of treatment.	20.0% 1/5 • Number of events 1 • Up to approximately 164 days All participants who received at least one dose of treatment.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@msd.com

Results disclosure agreements

• Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
• Publication restrictions are in place

Restriction type: OTHER