5 results
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…
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 main objective of the proposed study is to investigate the effect of plasma products and albumin on markers of endothelial function in a human endotoxemia model.
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.
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…