A study in healthy volunteers to assess how the body takes up different recipes of the test medicine (alectinib)

Category Primary study
Registry of TrialsISRCTN registry
Year 2022
INTERVENTION: Participants will receive a single oral 600 mg dose of one of the following across four study periods each lasting 4 days with a minimum 10 day washout period in between each period: 1. Reference alectinib capsule in the fasted and fed state 2. Alectinib prototype 1 tablet in the fasted and fed state 3. Alectinib prototype 2 tablet in the fasted and fed state 4. Alectinib prototype 3 tablet in the fasted and fed state CONDITION: Cancer ; Cancer PRIMARY OUTCOME: Relative bioavailability (Frel) for Cmax, AUC(0‐last) and AUC(0‐inf) of alectinib and its M4 metabolite measured throughout the study period SECONDARY OUTCOME: ; Measured throughout the study period:; 1. PK parameters, including but not limited to: Tlag, Tmax, Cmax, AUC(0‐last), AUC(0‐inf), Lambda‐z, T1/2, CL/F, Vz/F, MRT, and metabolite parent ratios for alectinib and its M4 metabolite; 2. Incidence of adverse events (AEs), physical examinations and change from baseline for vital signs, electrocardiograms (ECGs), physical examinations and laboratory safety tests; 3. Swallowability questionnaire utilising a 5‐point rating scale; INCLUSION CRITERIA: 1. Healthy males or non‐pregnant, non‐lactating healthy females of non‐childbearing potential 2. Aged 18 to 55 years inclusive at the time of signing informed consent 3. Body mass inde X(BMI) of 18.0 to 32.0 kg/m² as measured at screening 4. Must be willing and able to communicate and participate in the whole study 5. Must provide written informed consent 6. Must agree to adhere to the contraception requirements
Epistemonikos ID: fc613f533b5329e4d763dcf8c30878fc80d80254
First added on: Dec 17, 2022