A Study to Evaluate the Effects of Multiple Oral Doses of Itraconazole on the Single-dose Pharmacokinetics of Nemtabrutinib in Healthy Male Participants
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Nemtabrutinib
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •The key inclusion criteria include but are not limited to the following:
- •Is in good health based on medical history, physical examination, vital sign (VS) measurements, electrocardiograms (ECGs) and laboratory safety tests performed before allocation.
- •Has a body mass index (BMI) of18 to 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 (malignancy).
Arms & Interventions
Period 1: Nemtabrutinib
Participants receive a single oral dose of nemtabrutinib followed by a protocol specified wash-out period.
Intervention: Nemtabrutinib (Drug)
Period 2: Nemtabrutinib + Itraconazole
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.
Intervention: Nemtabrutinib (Drug)
Period 2: Nemtabrutinib + Itraconazole
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.
Intervention: Itraconazole (Drug)
Outcomes
Primary Outcomes
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Nemtabrutinib
Time Frame: At designated time points (up to approximately 10 days postdose)
Blood samples will be collected to determine the AUC0-inf of nemtabrutinib in plasma.
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-last) of Nemtabrutinib
Time Frame: At designated time points (up to approximately 10 days postdose)
Blood samples will be collected to determine the AUC0-last of nemtabrutinib in plasma.
Maximum Plasma Concentration (Cmax) of Nemtabrutinib
Time Frame: At designated time points (up to approximately 10 days postdose)
Blood samples will be collected to determine the Cmax of nemtabrutinib in plasma.
Time of Maximum Plasma Concentration (Tmax) of Nemtabrutinib
Time Frame: At designated time points (up to approximately 10 days postdose)
Blood samples will be collected to determine the Tmax of nemtabrutinib in plasma.
Apparent Terminal Half-life (t1/2) of Nemtabrutinib
Time Frame: At designated time points (up to approximately 10 days postdose)
Blood samples will be collected to determine the t1/2 of nemtabrutinib in plasma.
Apparent Clearance (CL/F) of Nemtabrutinib
Time Frame: At designated time points (up to approximately 10 days postdose)
Blood samples will be collected to determine the CL/F of nemtabrutinib in plasma.
Apparent Volume of Distribution (Vz/F) of Nemtabrutinib
Time Frame: At designated time points (up to approximately 10 days postdose)
Blood samples will be collected to determine the Vz/F of nemtabrutinib in plasma.
Secondary Outcomes
- Number of Participants Who Experience an Adverse Event (AE)(Up to approximately 6 weeks)
- Number of Participants Who Discontinue from Study Due to an AE(Up to approximately 6 weeks)