A Single and Multiple Dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics of MK-6024 in Healthy Chinese Participants

Registration

Registration

NCT06836037

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE1

Masking

DOUBLE

Status

COMPLETED

Enrollment

56

Start

2022-09-05

Primary completion

2023-02-02

Lead sponsor

Merck Sharp & Dohme LLC

Conditions

Healthy

Interventions

DRUG:Efinopegdutide; DRUG:Placebo

Results posted

FALSE

Individual participant data sharing

YES

Secondary identifiers

OTHER:MK-6024-011; REGISTRY:2020-005136-30

Registered primary outcomes

• Number of Participants Who Experience an Adverse Event (AE) [Up to approximately 112 days]
• Number of Participants Who Discontinue Study Treatment Due to an AE [Up to approximately 78 days]
• Maximum Plasma Concentration (Cmax) of Efinopegdutide- single dose [At designated time points up to 35 days]
• Time to Maximum Plasma Concentration (Tmax) of Efinopegdutide- single dose [At designated time points up to 35 days]
• Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Efinopegdutide- single dose [At designated timepoints up to 35 days]
• Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of Efinopegdutide- single dose [At designated timepoints up to 35 days]
• Terminal half life (t1/2) of Efinopegdutide- single dose [At designated timepoints up to 35 days]
• Apparent Clearance (CL) of Efinopegdutide- single dose [At designated timepoints up to 35 days]
• Volume of Distribution (Vz) of Efinopegdutide- single dose [At designated timepoints up to 35 days]
• Maximum Plasma Concentration (Cmax) of Efinopegdutide- multiple dose [At designated time points up to 112 days]
• Minimum Plasma Concentration (Cmin) of Efinopegdutide- multiple dose [At designated time points up to 112 days]
• Time to Maximum Plasma Concentration (Tmax) of Efinopegdutide- multiple dose [At designated time points up to 112 days]
• Terminal half life (t1/2) of Efinopegdutide- multiple dose [At designated timepoints up to 112 days]
• Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Efinopegdutide-multiple dose [At designated timepoints up to 112 days]
• Apparent Clearance (CL) of Efinopegdutide- multiple dose [At designated timepoints up to 112 days]
• Volume of Distribution at Steady State (Vss) of Efinopegdutide- multiple dose [At designated timepoints up to 112 days]
• Area Under the Concentration-Time Curve to the end of the dosing period (AUC 0-tau)of Efinopegdutide- multiple dose [At designated timepoints up to 78 days]