A Study of Diltiazem With a Single Dose of MK-6552 in Healthy Adult Participants (MK-6552-007)

NCT06662396 | Completed Phase 1 FDA Drug

• 2 other identifiers: 6552-007MK-6552-007
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The main goal of this study is to learn what happens to MK-6552 in a person's body over time (a pharmacokinetic or PK study). Researchers want to know what happens to MK-6552 in healthy adults when a single dose of MK-6552 is given with multiple doses of diltiazem. The researchers believe that multiple doses of diltiazem will not affect the highest amount of MK-6552 in the blood.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Maximum Plasma Concentration (Cmax) of MK-6552

  Blood samples will be collected to determine the Cmax of MK-6552 in plasma.

  Pre-dose and at designated time points up to 24 hours post dose

Secondary Outcomes (10)

• Number of Participants Who Experience and Adverse Event (AEs)

  Up to approximately 20 days

• Number of Participants Who Discontinue Study Due to an AE

  Up to approximately 20 days

• Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of MK-6552

  Pre-dose and at designated time points up to 96 hours post dose

• Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24) of MK-6552

  Pre-dose and at designated time points up to 24 hours post dose

• Time to Maximum Plasma Concentration (Tmax) of MK-6552

  Pre-dose and at designated time points up to 96 hours post dose

Study Arms (1)

MK-6552 + Diltiazem

EXPERIMENTAL

Participants receive a single dose of MK-6552 on Period 1 Day 1. Participants receive a Diltiazem every day (QD) for 6 days (Period 2 Days 1-6). On Period 2 Day 2 participants receive a single dose of MK-6552.

Drug: MK-6552; Drug: Diltiazem

Interventions

MK-6552 DRUG

Oral Gelatin Coated Capsule

MK-6552 + Diltiazem

Diltiazem DRUG

Oral Extended-Release Capsule

MK-6552 + Diltiazem

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Is in good health before randomization
• Body Mass Index (BMI) between 18 and 32 kg/m\^2, inclusive

You may not qualify if:

• 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)

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

ICON (Site 0001)

Lenexa, Kansas, 66219, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

Diltiazem

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 28, 2024
• Study Start: June 13, 2024
• Primary Completion: September 27, 2024
• Study Completion: September 27, 2024
• Last Updated: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)