A Drug-Drug Interaction Study of Diltiazem and MK-1167 in Healthy Adult Participants (MK-1167-006)

NCT06703463 | Completed Phase 1 FDA Drug

• 2 other identifiers: 1167-006MK-1167-006
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study this study is to learn about the safety of MK-1167 and if people tolerate it. Researchers will compare what happens to MK-1167 in the body when it is given with and without another medicine called diltiazem.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Number of participants who experience one or more adverse events (AEs)

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

  Up to approximately 99 days

• Number of participants who discontinue study intervention due to an AE

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

  Up to approximately 85 days

• Area under the concentration versus time curve from 0 to infinity after single dosing (AUC0-inf) of MK-1167 in plasma

  AUC0-inf of MK-1167 in plasma will be determined.

  Predose, and at designated timepoints up to 50 days post-dose

Secondary Outcomes (7)

• Area under the concentration versus time curve from 0 to last quantifiable sample (AUC0-last) of MK-1167 in plasma

  Predose, and at designated timepoints up to 50 days post-dose

• Maximum concentration (Cmax) of MK-1167 in plasma

  Predose, and at designated timepoints up to 50 days post-dose

• Concentration at hour 24 (C24) of MK-1167 in plasma

  Predose, and at designated timepoints up to 24 hours post-dose

• Time to maximum concentration (Tmax) of MK-1167 in plasma

  Predose, and at designated timepoints up to 50 days post-dose

• Apparent terminal half-life (t1/2) of MK-1167 in plasma

  Predose, and at designated timepoints up to 50 days post-dose

Study Arms (2)

MK-1167 Period 1

EXPERIMENTAL

On Day 1 a single dose of MK-1167 will be administered.

Drug: MK-1167

MK-1167 Period 2

EXPERIMENTAL

There will be a washout of at least 35 days between MK-1167 dosing in Period 1 and the first diltiazem dose in Period 2. In Period 2, diltiazem will be administered once daily (QD) for 49 consecutive days with a single dose of MK-1167 coadministered on Day 3.

Drug: MK-1167; Drug: Diltiazem

Interventions

MK-1167 DRUG

Administered via oral capsule per dosing regimen.

MK-1167 Period 1; MK-1167 Period 2

Diltiazem DRUG

Diltiazem hydrochloride administered at a dose of 240 mg QD via oral capsules.

MK-1167 Period 2

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing based on participant self-reporting
• Body mass index (BMI) ≥18.0 and ≤32.0 kg/m\^2
• Able to swallow multiple capsules
• In good health

You may not qualify if:

• History or presence of second- or third-degree atrioventricular heart block (except in participants with a functional artificial pacemaker)
• History or presence of clinically significant sick sinus syndrome
• History of cancer (malignancy) within the past 5 years
• Unable to refrain from or anticipates the use of any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dosing

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Celerion (Site 0002)

Lincoln, Nebraska, 68502, 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: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: November 25, 2024
• Study Start: October 17, 2023
• Primary Completion: February 2, 2024
• Study Completion: February 2, 2024
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)