A Randomized, Open Label, Parallel Group Phase 1 Study to Compare Safety, Tolerability and Pharmacokinetics of Subcutaneously Administered MK-1406 as Three Injections Compared With Two Injections in Healthy Adult Participants
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 400
- Primary Endpoint
- Part 1: Area Under the Concentration Time Curve From Time 0 to 4 Weeks (AUC0-4w) of MK-1406
Study Overview
Brief Summary
The purpose of this trial is to compare what happens to MK-1406 in the body of healthy participants when it is given as 2-injections and 3-injections. Researchers also want to learn about the safety of MK-1406 and if people tolerate it.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •The main inclusion criteria include but are not limited to the following:
- •Is in good health
- •Has body mass index (BMI) 18.0 to 32.0 kg/m^2
Exclusion Criteria
- •The main exclusion criteria include but are not limited to the following:
- •History of clinically significant endocrine, Gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- •History of cancer (malignancy)
Outcomes
Primary Outcomes
Part 1: Area Under the Concentration Time Curve From Time 0 to 4 Weeks (AUC0-4w) of MK-1406
Time Frame: Predose and at designated timepoints up to 4 weeks postdose
Blood samples will be collected at pre-specified timepoints to determine the AUC0-4w of MK-1406.
Part 1 and Part 2: Number of Participants Who Experience One or More Adverse Events (AEs)
Time Frame: Up to approximately 43 days postdose
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. The number of participants who experience an AE will be reported.
Part 1 and Part 2: Number of Participants Who Experience At Least One Solicited Injection-Site Reaction
Time Frame: Up to approximately 7 days postdose
Solicited injection-site reactions include tenderness, pain, redness/erythema, and swelling. Participants will record injection site reactions using a paper diary. The number of participants with solicited injection-site reactions will be reported.
Part 1 and Part 2: Number of Participants Who Discontinue Study Due to an AE
Time Frame: Up to approximately 43 days postdose
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study due to an AE will be reported.
Secondary Outcomes
- Part 1: Maximum Plasma Concentration (Cmax) of MK-1406(Predose and at designated timepoints up to 4 weeks postdose)
- Part 1: Time to Maximum Plasma Concentration (Tmax) of MK-1406(Predose and at designated timepoints up to 4 weeks postdose)
- Part 1: Plasma Concentration of MK-1406 at 4 Weeks (C4w)(Predose and at designated timepoints up to 4 weeks postdose)