A Study of MK-6552 and the Effect of Food in Healthy Participants (MK-6552-006)

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Drug: MK-6552

Study type: Interventional

Funder types: Industry

Identifiers

NCT06567002

6552-006

MK-6552-006 (Other Identifier)

Details and patient eligibility

About

The primary purpose of this study is to learn what happens to levels of MK-6552 in the blood when MK-6552 is given in different forms to healthy adult participants under fasted and fed conditions.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

The main inclusion criteria include but are not limited to the following:

• Be in good health

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)
• Has received any vaccine starting from 30 days prior to study intervention or is scheduled to receive any vaccine through 30 days following study intervention

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 6 patient groups

Sequence 1: (Treatment A) → (Treatment B) → (Treatment C) → (Treatment B) → (Treatment C)

Experimental group

Description:

Period 1: Participants receive MK-6552 Treatment A single dose administered orally under fasted conditions (Period 1 = 4 days). Period 2: Participants receive MK-6552 Treatment B single dose administered orally under fasted conditions (Period 2 = 4 days). Period 3: Participants receive Treatment C single dose administered orally under fasted conditions (Period 3 = 4 days). Period 4: Participants receive MK-6552 Treatment B single dose administered orally under fed conditions (Period 4 = 4 days). Period 5: Participants receive MK-6552 Treatment C single dose administered orally under fed conditions (Period 5 = 4 days). There will be a minimum 3-day washout between periods.

Treatment:

Drug: MK-6552

Sequence 2: (Treatment B) → (Treatment C) → (Treatment A) → (Treatment B) → (Treatment C)

Experimental group

Description:

Period 1: Participants receive MK-6552 Treatment B single dose administered orally under fasted conditions (Period 1 = 4 days). Period 2: Participants receive MK-6552 Treatment C single dose administered orally under fasted conditions (Period 2 = 4 days). Period 3: Participants receive MK-6552 Treatment A single dose administered orally under fasted conditions. (Period 3 = 4 days). Period 4: Participants receive MK-6552 Treatment B single dose administered orally under fed conditions (Period 4 = 4 days). Period 5: Participants receive MK-6552 Treatment C single dose administered orally under fed conditions (Period 5 = 4 days). There will be a minimum 3-day washout between periods.

Treatment:

Drug: MK-6552

Sequence 3: (Treatment C) → (Treatment A) → (Treatment B) → (Treatment B) → (Treatment C)

Experimental group

Description:

Period 1: Participants receive MK-6552 Treatment C single dose administered orally under fasted conditions (Period 1 = 4 days). Period 2: Participants receive MK-6552 Treatment A single dose administered orally under fasted conditions. (Period 2 = 4 days). Period 3: Participants receive MK-6552 Treatment B single dose administered orally under fasted conditions (Period 3 = 4 days). Period 4: Participants receive MK-6552 Treatment B single dose administered orally under fed conditions (Period 4 = 4 days). Period 5: Participants receive MK-6552 Treatment C single dose administered orally under fed conditions (Period 5 = 4 days). There will be a minimum 3-day washout between periods.

Treatment:

Drug: MK-6552

Sequence 4: (Treatment A) → (Treatment C) → (Treatment B) → (Treatment C) → (Treatment B)

Experimental group

Description:

Period 1: Participants receive MK-6552 Treatment A single dose administered orally under fasted conditions (Period 1 = 4 days). Period 2: Participants receive MK-6552 Treatment C single dose administered orally under fasted conditions (Period 2 = 4 days). Period 3: Participants receive MK-6552 Treatment B single dose administered orally under fasted conditions (Period 3 = 4 days). Period 4: Participants receive MK-6552 Treatment C single dose administered orally under fed conditions (Period 4 = 4 days). Period 5: Participants receive MK-6552 Treatment B single dose administered orally under fed conditions (Period 5 = 4 days). There will be a minimum 3-day washout between periods.

Treatment:

Drug: MK-6552

Sequence 5: (Treatment B) → (Treatment A) → (Treatment C) → (Treatment C) → (Treatment B)

Experimental group

Description:

Period 1: Participants receive MK-6552 Treatment B single dose administered orally under fasted conditions (Period 1 = 4 days). Period 2: Participants receive MK-6552 Treatment A single dose administered orally under fasted conditions. (Period 2 = 4 days). Period 3: Participants receive MK-6552 Treatment C single dose administered orally under fasted conditions (Period 3 = 4 days). Period 4: Participants receive MK-6552 Treatment C single dose administered orally under fed conditions (Period 4 = 4 days). Period 5: Participants receive MK-6552 Treatment B single dose administered orally under fed conditions (Period 5 = 4 days). There will be a minimum 3-day washout between periods.

Treatment:

Drug: MK-6552

Sequence 6: (Treatment C) → (Treatment B) → (Treatment A) → (Treatment C) → (Treatment B)

Experimental group

Description:

Period 1: Participants receive MK-6552 Treatment C single dose administered orally under fasted conditions (Period 1 = 4 days). Period 2: Participants receive MK-6552 Treatment B single dose administered orally under fasted conditions (Period 2 = 4 days). Period 3: Participants receive MK-6552 Treatment A single dose administered orally under fasted conditions. (Period 3 = 4 days). Period 4: Participants receive MK-6552 Treatment C single dose administered orally under fed conditions (Period 4 = 4 days). Period 5: Participants receive MK-6552 Treatment B single dose administered orally under fed conditions (Period 5 = 4 days). There will be a minimum 3-day washout between periods.

Treatment:

Drug: MK-6552