A Phase 1 interventional study of Nemtabrutinib and Itraconazole in Healthy, sponsored by Merck Sharp & Dohme LLC. Completed at 1 site in United States. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-14.
Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Basic science
The goal of this study is to learn what happens to levels of nemtabrutinib in a person's body over time. Researchers will compare what happens to nemtabrutinib in the body when it is given with or without another medicine called itraconazole.
Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 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 receive a single oral dose of nemtabrutinib followed by a protocol specified wash-out period.
Drug: Nemtabrutinib
Participants receive oral doses of itraconazole once daily on Days 1 to 13 with a single oral dose of nemtabrutinib given with itraconazole on Day 4.
Drug: Nemtabrutinib · Drug: Itraconazole
Oral administration
Also known as: MK-1026, ARQ-531
Oral administration
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Nemtabrutinib
Blood samples will be collected to determine the AUC0-inf of nemtabrutinib in plasma.
Time frame: At designated time points (up to approximately 10 days postdose)
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-last) of Nemtabrutinib
Blood samples will be collected to determine the AUC0-last of nemtabrutinib in plasma.
Time frame: At designated time points (up to approximately 10 days postdose)
Maximum Plasma Concentration (Cmax) of Nemtabrutinib
Blood samples will be collected to determine the Cmax of nemtabrutinib in plasma.
Time frame: At designated time points (up to approximately 10 days postdose)
Time of Maximum Plasma Concentration (Tmax) of Nemtabrutinib
Blood samples will be collected to determine the Tmax of nemtabrutinib in plasma.
Time frame: At designated time points (up to approximately 10 days postdose)
Apparent Terminal Half-life (t1/2) of Nemtabrutinib
Blood samples will be collected to determine the t1/2 of nemtabrutinib in plasma.
Time frame: At designated time points (up to approximately 10 days postdose)
Apparent Clearance (CL/F) of Nemtabrutinib
Blood samples will be collected to determine the CL/F of nemtabrutinib in plasma.
Time frame: At designated time points (up to approximately 10 days postdose)
Apparent Volume of Distribution (Vz/F) of Nemtabrutinib
Blood samples will be collected to determine the Vz/F of nemtabrutinib in plasma.
Time frame: At designated time points (up to approximately 10 days 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 6 weeks
Number of Participants Who Discontinue from 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 experience an AE will be reported.
Time frame: Up to approximately 6 weeks
Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Merck Sharp & Dohme LLC