A Phase 1 interventional study of MK-1708 and Itraconazole in Alzheimer's Disease, sponsored by Merck Sharp & Dohme LLC. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-18.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 1, Interventional, and Treatment
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.
3,681 studies on the registry are indexed under Alzheimer Disease; 875 are open to participants now.
This study's enrollment of 12 is below the median of 70 across 2,809 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 132 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
The key inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The key exclusion criteria include but are not limited to the following:
Participants will receive a single oral dose of MK-1708 on Day 1.
Drug: 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.
Drug: MK-1708 · Drug: Itraconazole
Oral administration
Oral administration
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-1708
Blood samples will be collected to determine the AUC0-inf of MK-1708.
Time frame: Predose and at designated timepoints up to approximately 2 weeks postdose
Number of Participants Who Experience an Adverse Event (AE)
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.
Time frame: Up to approximately 11 weeks
Number of Participants Who Discontinue Study Due to an AE
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.
Time frame: Up to approximately 11 weeks
Area Under the Concentration-Time Curve from Time 0 to Last Quantifiable Concentration (AUC0-Last) of MK-1708
Blood samples will be collected to determine the AUC0-last of MK-1708.
Time frame: Predose and at designated timepoints up to approximately 2 weeks postdose
Maximum Plasma Concentration (Cmax) of MK-1708
Blood samples will be collected to determine the Cmax of MK-1708.
Time frame: Predose and at designated timepoints up to approximately 2 weeks postdose
Time to Maximum Plasma Concentration (Tmax) of MK-1708
Blood samples will be collected to determine the Tmax of MK-1708.
Time frame: Predose and at designated timepoints up to approximately 2 weeks postdose
Plasma Concentration at 24 Hours (C24) of MK-1708
Blood samples will be collected to determine the C24 of MK-1708.
Time frame: Predose and at designated timepoints up to 24 hours postdose
Apparent Clearance (CL/F) of MK-1708
Blood samples will be collected to determine the CL/F of MK-1708.
Time frame: Predose and at designated timepoints up to approximately 2 weeks postdose
Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-1708
Blood samples will be collected to determine the Vz/F of MK-1708.
Time frame: Predose and at designated timepoints up to approximately 2 weeks postdose
Apparent Terminal Half-life (t1/2) of MK-1708
Blood samples will be collected to determine the t1/2 of MK-1708.
Time frame: Predose and at designated timepoints up to approximately 2 weeks postdose
Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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