A Study to Evaluate the Effects of Itraconazole on MK-1708 in Healthy Participants (MK-1708-003)
- Registration Number
- NCT06586606
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Period 1: MK-1708 MK-1708 Participants will receive a single oral dose of MK-1708 on Day 1. Period 2: MK-1708 and Itraconazole MK-1708 A washout period of at least 10 days will occur between MK-1708 dosing in Period 1 and the first itraconazole dosing in Period 2. In Period 2, participants will receive itraconazole twice daily on Day 1 and once daily on Days 2 through Day 19. Participants will also receive a single oral dose of MK-1708 on Day 4. Period 2: MK-1708 and Itraconazole Itraconazole A washout period of at least 10 days will occur between MK-1708 dosing in Period 1 and the first itraconazole dosing in Period 2. In Period 2, participants will receive itraconazole twice daily on Day 1 and once daily on Days 2 through Day 19. Participants will also receive a single oral dose of MK-1708 on Day 4.
- Primary Outcome Measures
Name Time Method Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-1708 Predose and at designated timepoints up to approximately 2 weeks postdose Blood samples will be collected to determine the AUC0-inf of MK-1708.
Number of Participants Who Experience an Adverse Event (AE) Up to approximately 11 weeks An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Number of Participants Who Discontinue Study Due to an AE Up to approximately 11 weeks An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study due to an AE will be reported.
- Secondary Outcome Measures
Name Time Method Area Under the Concentration-Time Curve from Time 0 to Last Quantifiable Concentration (AUC0-Last) of MK-1708 Predose and at designated timepoints up to approximately 2 weeks postdose Blood samples will be collected to determine the AUC0-last of MK-1708.
Maximum Plasma Concentration (Cmax) of MK-1708 Predose and at designated timepoints up to approximately 2 weeks postdose Blood samples will be collected to determine the Cmax of MK-1708.
Time to Maximum Plasma Concentration (Tmax) of MK-1708 Predose and at designated timepoints up to approximately 2 weeks postdose Blood samples will be collected to determine the Tmax of MK-1708.
Plasma Concentration at 24 Hours (C24) of MK-1708 Predose and at designated timepoints up to 24 hours postdose Blood samples will be collected to determine the C24 of MK-1708.
Apparent Clearance (CL/F) of MK-1708 Predose and at designated timepoints up to approximately 2 weeks postdose Blood samples will be collected to determine the CL/F of MK-1708.
Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-1708 Predose and at designated timepoints up to approximately 2 weeks postdose Blood samples will be collected to determine the Vz/F of MK-1708.
Apparent Terminal Half-life (t1/2) of MK-1708 Predose and at designated timepoints up to approximately 2 weeks postdose Blood samples will be collected to determine the t1/2 of MK-1708.
Trial Locations
- Locations (1)
QPS-MRA, LLC ( Site 0001)
🇺🇸South Miami, Florida, United States