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

Phase 1
Completed
Conditions
Interventions
Registration Number
NCT06703463
Lead Sponsor
Merck Sharp & Dohme LLC
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
16
Inclusion Criteria

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

  • 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
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Exclusion Criteria

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

  • 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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
MK-1167 Period 1MK-1167On Day 1 a single dose of MK-1167 will be administered.
MK-1167 Period 2MK-1167There 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.
MK-1167 Period 2DiltiazemThere 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.
Primary Outcome Measures
NameTimeMethod
Number of participants who experience one or more adverse events (AEs)Up to approximately 99 days

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.

Number of participants who discontinue study intervention due to an AEUp to approximately 85 days

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.

Area under the concentration versus time curve from 0 to infinity after single dosing (AUC0-inf) of MK-1167 in plasmaPredose, and at designated timepoints up to 50 days post-dose

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

Secondary Outcome Measures
NameTimeMethod
Area under the concentration versus time curve from 0 to last quantifiable sample (AUC0-last) of MK-1167 in plasmaPredose, and at designated timepoints up to 50 days post-dose

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

Maximum concentration (Cmax) of MK-1167 in plasmaPredose, and at designated timepoints up to 50 days post-dose

Cmax of MK-1167 in plasma will be determined.

Concentration at hour 24 (C24) of MK-1167 in plasmaPredose, and at designated timepoints up to 24 hours post-dose

C24 of MK-1167 in plasma will be determined.

Time to maximum concentration (Tmax) of MK-1167 in plasmaPredose, and at designated timepoints up to 50 days post-dose

Tmax of MK-1167 in plasma will be determined.

Apparent terminal half-life (t1/2) of MK-1167 in plasmaPredose, and at designated timepoints up to 50 days post-dose

t1/2 of MK-1167 in plasma will be determined.

Apparent clearance (CL/F) of MK-1167 in plasmaPredose, and at designated timepoints up to 50 days post-dose

CL/F of MK-1167 in plasma will be determined.

Apparent volume of distribution during terminal phase (Vz/F) of MK-1167 in plasmaPredose, and at designated timepoints up to 50 days post-dose

Vz/F of MK-1167 in plasma will be determined.

Trial Locations

Locations (1)

Celerion (Site 0002)

🇺🇸

Lincoln, Nebraska, United States

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