9 results
Primary ObjectiveThe primary objective is to investigate the PK of the MMF * the main metabolite of DMF * following administration of a delayed-and slow-release tablet formulation (FP187-GC) and the marketed enteric-coated delayed release…
Objectives: Primary:• To evaluate the long-term safety and tolerability of AG-348Secondary:• To evaluate the long-term efficacy of AG-348• To evaluate the efficacy of AG-348 in increasing hemoglobin (Hb) concentrations in subjects who previously…
Primary objective: to explore 18F-FDHT PET/CT as a predictor of response in patients with metastasized CRPC to be treated with enzalutamide. Secondary objective: to explore 18F-FDHT PET/CT as a predictor of clinical survival endpoints in patients…
The aim of this study is to evaluate androgen receptor (AR) and estrogen receptor (ER) expression non-invasively by means of PET imaging with the tracers 18F-FDHT and 18F-FES. To verify the PET results, the standard diagnostic biopsy will be…
CORE PERIODPrimary:* Evaluate the safety and tolerability of up to 24 weeks of AG-348 administration in patients with pyruvate kinase deficiency (PK deficiency).Secondary:* Evaluate the pharmacokinetics (PK) of AG-348 and the metabolite AGI-8702.*…
Feasibility to detect a difference in uptake on 18F-FDHT scan after 4 weeks of treatment with bicalutamide in metastatic breast cancer patients.
The primary objective of the study is to evaluate the efficacy of treatment with AG-348, as assessed by the reduction in transfusion burden.Secondary: The secondary objective of this study is to evaluate the safety of treatment with AG 348.
Primary:• To evaluate the efficacy of treatment with AG-348 compared with placebo in increasing hemoglobin (Hb) concentrationsSecondary:• To evaluate the safety of AG-348• To determine the effect of the study treatment regimens on markers of…
To study the safety and efficacy of mitapivat in the treatment of adult subjects with sickle cell disease.