5 results
The study objectives are:- to characterize the biotransformation pathways, the routes and rates of excretion, and total recovery of the 14C-labeled research medication and its radiolabeled metabolites- to characterize the pharmacokinetics (PK) of…
Primary Study Objective: To evaluate the effect of telotristat etiprate versus placebo over the double-blind portion of the study on the incidence of treatment-emergent adverse events (TEAEs)
The primary objective of the study is to confirm that at least 1 or more doses of telotristat etiprate compared to placebo is effective in reducing the change from baseline in the number of daily bowel movements (BMs) averaged over the 12-week…
Objective 1: analyze the effect of short-term treatment with high dose glucocorticoids on vasculopathic abnormalities as measured by NCM in patients with very early SSc.Objective 2: investigate the effects of glucocorticoids on signs and symptoms of…
The primary objective of this study is to evaluate the long-term safety and tolerability of orally administered telotristat etiprate.The secondary objective is to evaluate changes in patients* quality of life (QOL) through week 84.