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

Phase 1

Terminated

• Conditions: Healthy
• Interventions: Drug: MK-6552

• Registration Number: NCT06567002
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-20
• Study First Submitted QC: 2024-08-20
• Study First Posted: 2024-08-22
• Study Start: 2024-09-09
• Status Verified: 2024-11
• Primary Completion: 2024-11-15
• Study Completion: 2024-11-15
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1: (Treatment A) → (Treatment B) → (Treatment C) → (Treatment B) → (Treatment C)	MK-6552	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.
Sequence 2: (Treatment B) → (Treatment C) → (Treatment A) → (Treatment B) → (Treatment C)	MK-6552	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.
Sequence 3: (Treatment C) → (Treatment A) → (Treatment B) → (Treatment B) → (Treatment C)	MK-6552	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.
Sequence 4: (Treatment A) → (Treatment C) → (Treatment B) → (Treatment C) → (Treatment B)	MK-6552	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.
Sequence 5: (Treatment B) → (Treatment A) → (Treatment C) → (Treatment C) → (Treatment B)	MK-6552	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.
Sequence 6: (Treatment C) → (Treatment B) → (Treatment A) → (Treatment C) → (Treatment B)	MK-6552	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.

Primary Outcome Measures

Name	Time	Method
Concentration at 8 hours (C8h) of MK-6552 in a Fasted State	8 hours postdose	Blood samples will be collected to determine the C8h of MK-6552.
Concentration at 16 hours (C16h) of MK-6552 in a Fasted State	16 hours postdose	Blood samples will be collected to determine the C16h of MK-6552.
Area Under the Plasma Concentration-Time Curve from Time 0 to Last Quantifiable Concentration (AUC0-last) of MK-6552 in a Fasted State	Predose and at designated timepoints approximately up to 3 days postdose	Blood samples will be collected to determine the AUC0-last of MK-6552.
Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of MK-6552 in a Fasted State	Predose and at designated timepoints approximately up to 3 days postdose	Blood samples will be collected to determine the AUC0-inf of MK-6552.
Maximum Concentration (Cmax) of MK-6552 in a Fasted State	Predose and at designated timepoints approximately up to 3 days postdose	Blood samples will be collected to determine the Cmax of MK-6552.
Time to maximum concentration (Tmax) of MK-6552 in a Fasted State	Predose and at designated timepoints approximately up to 3 days postdose	Blood samples will be collected to determine the Tmax of MK-6552.
Apparent Terminal Half-life (t1/2) of MK-6552 in a Fasted State	Predose and at designated timepoints approximately up to 3 days postdose	Blood samples will be collected to determine the t1/2 of MK-6552.

Secondary Outcome Measures

Name	Time	Method
Tmax of MK-6552 in a Fed or Fasted State	Predose and at designated timepoints approximately up to 3 days postdose	Blood samples will be collected to determine the Tmax of MK-6552.
C16h of MK-6552 in a Fed or Fasted State	16 hours postdose	Blood samples will be collected to determine the C16h of MK-6552.
Number of participants with one or more adverse events (AE)	Up to approximately day 35	An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants who experience an AE will be reported.
Number of participants discontinuing from study therapy due to AE	Up to approximately day 35	An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants who discontinue study treatment due to an AE will be reported.
Cmax of MK-6552 in a Fed or Fasted State	Predose and at designated timepoints approximately up to 3 days postdose	Blood samples will be collected to determine the Cmax of MK-6552.
t1/2 of MK-6552 in a Fed or Fasted State	Predose and at designated timepoints approximately up to 3 days postdose	Blood samples will be collected to determine the t1/2 of MK-6552.
AUC0-last of MK-6552 in a Fed or Fasted State	Predose and at designated timepoints approximately up to 3 days postdose	Blood samples will be collected to determine the AUC0-last of MK-6552.
AUC0-inf of MK-6552 in a Fed or Fasted State	Predose and at designated timepoints approximately up to 3 days postdose	Blood samples will be collected to determine the AUC0-inf of MK-6552.
C8h of MK-6552 in a Fed or Fasted State	8 hours postdose	Blood samples will be collected to determine the C8h of MK-6552.

Trial Locations

Locations (1)

QPS-MRA, LLC-Early Phase ( Site 0001); 🇺🇸 South Miami, Florida, United States