Single and Multiple Dose Study of MK-1708 in Healthy Japanese Participants (MK-1708-004)

Merck Sharp & Dohme (MSD)

Status and phase: Not yet enrolling; Phase 1

Conditions: Alzheimer Disease; Amyotrophic Lateral Sclerosis

Treatments: Drug: Placebo; Drug: MK-1708

Study type: Interventional

Funder types: Industry

Identifiers

NCT06566963

1708-004

Details and patient eligibility

About

This is a study of the safety, tolerability, and pharmacokinetics (PK) of MK-1708 in healthy Japanese participants. The primary objectives are to evaluate the safety and tolerability of single (Part 1) and multiple (Part 2) doses of MK-1708.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Be in good health
• Body Mass Index (BMI) of18 to 32 kg/m^2

Exclusion criteria

• History of significant clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
• Mentally incapacitated
• History of cancer (malignancy)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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64 participants in 8 patient groups

Part 1: Panel A

Experimental group

Description:

Participants in Panel A receive single doses of placebo or MK-1708 Dose 1 (Period 1) and Dose 3 (Period 2).

Treatment:

Drug: MK-1708

Drug: Placebo

Part 1: Panel B

Experimental group

Description:

Participants in Panel B receive single doses of placebo or MK-1708 Dose 2 (Period 1) and Dose 4 (Period 2).

Treatment:

Drug: MK-1708

Drug: Placebo

Part 1: Panel C

Experimental group

Description:

Participants in Panel C receive a single dose of placebo or MK-1708 Dose 1 in Period 1.

Treatment:

Drug: MK-1708

Drug: Placebo

Part 1: Panel D

Experimental group

Description:

Participants in Panel D receive single doses of placebo or MK-1708 Dose 1 (Period 1) and Dose 3 (Period 2).

Treatment:

Drug: MK-1708

Drug: Placebo

Part 1: Panel E

Experimental group

Description:

Participants in Panel E receive single doses of placebo or MK-1708 Dose 2 (Period 1) and Dose 4 (Period 2).

Treatment:

Drug: MK-1708

Drug: Placebo

Part 2: Panel F

Experimental group

Description:

Participants in Panel F receive multiple doses of placebo or MK-1708.

Treatment:

Drug: MK-1708

Drug: Placebo

Part 2: Panel G

Experimental group

Description:

Participants in Panel G receive multiple doses of placebo or MK-1708.

Treatment:

Drug: MK-1708

Drug: Placebo

Part 2: Panel H

Experimental group

Description:

Participants in Panel H receive multiple doses of placebo or MK-1708.

Treatment:

Drug: MK-1708

Drug: Placebo