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…
To compare tumor [11C]erlotinib pharmacokinetics in NSCLC patients with and without erlotinib therapy. Also, to assess the relationship of venous sampling versus arterial, of tumor [11C]erlotinib uptake and blood flow with and without therapy, and…
Primary Objective: To study the tumour pharmacokinetics of [11C]erlotinib in NSCLC patients in vivo and relating uptake with EGFR mutations, obtained from tumour biopsies. Secondary Objective(s): 1. to define the test-retest reproducibility of [11C]…
Primary Objective:*Evaluate the safety and tolerability of AMG 596 administered by continuous intravenous (cIV) infusion in monotherapy (Arm 1) and in combination with AMG 404 (anti-programmed cell death-1 (PD-1) antibody( Arm 2) in subjects with…
To evaluate interlesional and intralesional differences in [11C]erlotinib uptake in EGFR mutated (EGFR+) NSCLC patients who are at different stages in their TKI treatment. To correlate tumor [11C]erlotinib uptake to EGFR mutational status, tumor…
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…
We aim to investigate whether sodium oxybate can be used as a novel treatment in psychiatric patients with catatonia. Our primary objective is: To determine if sodium oxybate is effective as a novel treatment in psychiatric patients with catatonia…
To evaluate the efficacy of sodium oxybate (SXB) as a medical intervention to treat disrupted night sleep in the ICU.