Clinical trial NCT06703463: A Drug-Drug Interaction Study of Diltiazem and MK-1167 in Healthy Adult Participants (MK-1167-006)
Official title: A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Effect of Multiple Doses of Diltiazem on the Single-Dose Pharmacokinetics of MK-1167 in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-11-25
Enrollment: 16
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

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

Primary outcomes:
measure: Number of participants who experience one or more adverse events (AEs)
timeFrame: Up to approximately 99 days
measure: Number of participants who discontinue study intervention due to an AE
timeFrame: Up to approximately 85 days
measure: Area under the concentration versus time curve from 0 to infinity after single dosing (AUC0-inf) of MK-1167 in plasma
timeFrame: Predose, and at designated timepoints up to 50 days post-dose
Secondary outcomes:
measure: Area under the concentration versus time curve from 0 to last quantifiable sample (AUC0-last) of MK-1167 in plasma
timeFrame: Predose, and at designated timepoints up to 50 days post-dose
measure: Maximum concentration (Cmax) of MK-1167 in plasma
timeFrame: Predose, and at designated timepoints up to 50 days post-dose
measure: Concentration at hour 24 (C24) of MK-1167 in plasma
timeFrame: Predose, and at designated timepoints up to 24 hours post-dose
measure: Time to maximum concentration (Tmax) of MK-1167 in plasma
timeFrame: Predose, and at designated timepoints up to 50 days post-dose
measure: Apparent terminal half-life (t1/2) of MK-1167 in plasma
timeFrame: Predose, and at designated timepoints up to 50 days post-dose
measure: Apparent clearance (CL/F) of MK-1167 in plasma
timeFrame: Predose, and at designated timepoints up to 50 days post-dose
measure: Apparent volume of distribution during terminal phase (Vz/F) of MK-1167 in plasma
timeFrame: Predose, and at designated timepoints up to 50 days post-dose
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion (Site 0002)
state: Nebraska
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: