A Clinical Trial in Healthy Participants to Learn How Itraconazole Affects MK-2828 Levels and How MK-2828 Affects Midazolam Levels (MK-2828-007)

NCT07435194 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 2828-007MK-2828-007
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The main goals of this study are:

• To learn what happens to one dose of MK-2828 in a healthy person's body over time when it is taken with itraconzole
• To learn what happens to one dose of midazolam in a healthy person's body over time when it is taken with MK-2828 Researchers want to learn if the levels of MK-2828 in the body are about the same when MK-2828 is taken with itraconazole as when it is taken alone. They also want to know if taking MK-2828 more than once affects how much midazolam is in the body after a single dose.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Part 1 (Itraconazole): Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of MK-2828

  Blood samples will be collected at multiple time points to determine the AUC0-inf of MK-2828.

  Predose and at designated timepoints up to approximately 288 hours (hrs) postdose

• Part 1 (Itraconazole): Maximum Plasma Concentration (Cmax) of MK-2828

  Blood samples will be collected at multiple time points to determine the Cmax of MK-2828.

  Predose and at designated timepoints up to approximately 288 hrs postdose

• Part 2 (Midazolam): Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Midazolam

  Blood samples will be collected at multiple time points to determine the AUC0-inf of Midazolam.

  Predose and at designated timepoints up to approximately 24hrs postdose

• Part 2 (Midazolam): Maximum Plasma Concentration (Cmax) of Midazolam

  Blood samples will be collected at multiple time points to determine the Cmax of Midazolam.

  Predose and at designated timepoints up to approximately 24hrs postdose

Secondary Outcomes (18)

• Part 1 (Itraconazole): Area Under the Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of MK-2828

  Predose and at designated timepoints up to approximately 288 hrs postdose

• Part 1 (Itraconazole): Area Under the Curve From Time 0 to 24 Hours (AUC0-24hrs) of MK-2828

  Predose and at designated timepoints up to approximately 24 hrs postdose

• Part 1 (Itraconazole): Time to Maximum Plasma Concentration (Tmax) of MK-2828

  Predose and at designated timepoints up to approximately 288 hrs postdose

• Part 1 (Itraconazole): Apparent Terminal Half-life (t1/2) of MK-2828

  Predose and at designated timepoints up to approximately 288 hrs postdose

• Part 1 (Itraconazole): Apparent Clearance (CL/F) of MK-2828

  Predose and at designated timepoints up to approximately 288 hrs postdose

Study Arms (2)

Part 1: Itraconazole

EXPERIMENTAL

Participants will receive multiple oral doses of Itraconazole with a single oral dose of MK-2828.

Drug: MK-2828; Drug: Itraconazole

Part 2: Midazolam

EXPERIMENTAL

Participants will receive multiple oral doses of MK-2828 with a single oral dose of midazolam.

Drug: MK-2828; Drug: Midazolam

Interventions

MK-2828 DRUG

Administered orally as capsule

Part 1: Itraconazole; Part 2: Midazolam

Itraconazole DRUG

Administered orally as syrup

Part 1: Itraconazole

Midazolam DRUG

Administered orally as syrup

Part 2: Midazolam

Eligibility Criteria

• Age: 24 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Participant is in good health

You may not qualify if:

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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Fortea CRU Madison ( Site 0001)

Madison, Wisconsin, 53704, United States

RECRUITING

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

Itraconazole; Midazolam

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@merck.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: February 27, 2026
• Study Start: March 6, 2026
• Primary Completion (Estimated): August 12, 2026
• Study Completion (Estimated): August 12, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)