8 results
Primary Objectives:Part 1:To assess the relative bioavailability and bioequivalence of JZP-258 compared with Xyrem oral solution under fasting and fed conditions.To evaluate the pharmacokinetics (PK) of JZP-258 under fasting and fed conditions (food…
The purpose of the study is to investigate how much JZP-258 is absorbed into the body, how fast JZP-258 is absorbed and eliminated from the body (this is called pharmacokinetics) compared to Xyrem. This comparison is called the relative…
During the study, the 4 KEY-507 oral solutions (KEY-507-A, KEY-507-G, KEY-507-C, and KEY 507-D) will be investigated and compared to Xyrem. The purpose of the study is to investigate how quickly and to what extent KEY-507 oral solutions are absorbed…
Primary objectivesDetermine the effect of Sorafenib (Bay 43-9006) on the uptake of In-111 labeled chimeric monoclonal antibody G250 (In-111-cG250) by RCC lesions.Determine the effect of Sorafenib (Bay 43-9006) on the uptake of In-111 labeled…
Primary objective:- To determine the clinical efficacy of multiple doses of 177Lu-DOTA-cG250 at MTD in patients with advanced renal cancer using RECIST criteriaSecondary objectives:- To determine the toxicity of the treatment as defined by NCI…
Primary objectives are:1) To evaluate the efficacy of Xyrem (sodium oxybate) oral solution in the treatment of cataplexy in pediatric subjects with narcolepsy2) To evaluate the safety of Xyrem in the treatment of cataplexy in pediatric subjects with…
* To decrease mortality in MS-LCH by an early switch of patients with risk organ involvement, who do not respond to front-line therapy, to a more intensive treatment (Stratum III or Stratum IV).* To reduce reactivation rates and permanent…
With this proof-of-concept study, we will address i. differences in dopamine release in T2DM patients versus historical lean controls, ii. whether timed restoring of dopamine signalling improves dopamine release and iii. whether this reinstatement…