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A Clinical Trial of MK-1406 in Healthy Participants (MK-1406-008)

ConditionHealthy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-64
SponsorMerck Sharp & Dohme LLC

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Is in good health

Has body mass index (BMI) 18.0 to 32.0 kg/m²

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • MK-1406

    Drug

    Subcutaneous administration

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: MK-1406 3-InjectionsExperimental treatment 1 intervention
Group B: MK-1406 2-InjectionsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part 1: Area Under the Concentration Time Curve From Time 0 to 4 Weeks (AUC0-4w) of MK-1406

Blood samples will be collected at pre-specified timepoints to determine the AUC0-4w of MK-1406.

Time frame
Predose and at designated timepoints up to 4 weeks postdose
2

Part 1 and Part 2: Number of Participants Who Experience One or More Adverse Events (AEs)

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.

Time frame
Up to approximately 43 days postdose
3

Part 1 and Part 2: Number of Participants Who Experience At Least One Solicited Injection-Site Reaction

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.

Time frame
Up to approximately 7 days postdose
4

Part 1 and Part 2: Number of Participants Who Discontinue Study Due to an AE

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.

Time frame
Up to approximately 43 days postdose

Secondary outcomes

1

Part 1: Maximum Plasma Concentration (Cmax) of MK-1406

Blood samples will be collected at pre-specified timepoints to determine the Cmax of MK-1406.

Time frame
Predose and at designated timepoints up to 4 weeks postdose
2

Part 1: Time to Maximum Plasma Concentration (Tmax) of MK-1406

Blood samples will be collected at pre-specified timepoints to determine the Tmax of MK-1406.

Time frame
Predose and at designated timepoints up to 4 weeks postdose
3

Part 1: Plasma Concentration of MK-1406 at 4 Weeks (C4w)

Blood samples will be collected at pre-specified timepoints to determine the C4w of MK-1406.

Time frame
Predose and at designated timepoints up to 4 weeks postdose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Merck Sharp & Dohme LLC

Lead sponsor

Source ClinicalTrials.gov
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