4 results
The primary objective of this study is to show bioequivalence between nitisinone oral suspension and nitisinone capsules.Secondary objectives of this study are:- To assess the effect of food on the bioavailability of nitisinone oral suspension.- To…
The primary purpose of the study is to investigate whether the new 20 mg capsule of Orfadin® (nitisinone) has a similar bioavailability in the body (gives the same concentration in the blood) as two of the marketed capsules of 10 mg. The secundary…
Primary- Part 1: To identify recommended Phase 2 doses and schedules (RP2Ds) for each combination.- Part 2: To characterize the safety of each RP2D for each combinationSecondary- To characterize the pharmacokinetics and pharmacodynamics of each…
The primary objective is to compare the efficacy of Tec-Dara (Arm A) with DPd/DVd (Arm B) in participants who have received 1 to 3 prior lines of therapy, including a PI and lenalidomide.