Clinical trial NCT06586606: A Study to Evaluate the Effects of Itraconazole on MK-1708 in Healthy Participants (MK-1708-003)
Official title: A Two-Period Study to Evaluate the Effects of Multiple Oral Doses of Itraconazole on the Single Dose PK of MK-1708 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The goal of the study is to see what happens to levels of MK-1708 a person's body over time. Researchers will compare what happens to MK-1708 in the body when it is given with or without a medicine called itraconazole.


Eligibility criteria: Inclusion Criteria:

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

* Is in good health before randomization
* Has a body mass index (BMI) ≥18.5 and ≤32 kg/m\^2, inclusive

Exclusion Criteria:

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

* Has a 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
* Has a history of cancer

Primary outcomes:
measure: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-1708
timeFrame: Predose and at designated timepoints up to approximately 2 weeks postdose
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 11 weeks
measure: Number of Participants Who Discontinue Study Due to an AE
timeFrame: Up to approximately 11 weeks
Secondary outcomes:
measure: Area Under the Concentration-Time Curve from Time 0 to Last Quantifiable Concentration (AUC0-Last) of MK-1708
timeFrame: Predose and at designated timepoints up to approximately 2 weeks postdose
measure: Maximum Plasma Concentration (Cmax) of MK-1708
timeFrame: Predose and at designated timepoints up to approximately 2 weeks postdose
measure: Time to Maximum Plasma Concentration (Tmax) of MK-1708
timeFrame: Predose and at designated timepoints up to approximately 2 weeks postdose
measure: Plasma Concentration at 24 Hours (C24) of MK-1708
timeFrame: Predose and at designated timepoints up to 24 hours postdose
measure: Apparent Clearance (CL/F) of MK-1708
timeFrame: Predose and at designated timepoints up to approximately 2 weeks postdose
measure: Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-1708
timeFrame: Predose and at designated timepoints up to approximately 2 weeks postdose
measure: Apparent Terminal Half-life (t1/2) of MK-1708
timeFrame: Predose and at designated timepoints up to approximately 2 weeks postdose
Other outcomes:
Locations:
city: South Miami
country: United States
facility: QPS-MRA, LLC ( Site 0001)
state: Florida
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: