17 results
Part I will assess the safety, tolerability and pharmacokinetics of single, escalating doses of ABT-639Part II will assess the effect of food on the pharmacokinetics of single doses of ABT-639Part III will asses the safety, tolerability, and…
In patients with primary biliary cirrhosis (PBC) taking UDCA, to assess the effects of INT-747 on: Primary: - Alkaline phosphatase (AP) levels - SafetySecondary: - Hepatocellular injury and liver function - Disease-specific and general health…
SADTo evaluate the safety and tolerability of ascending single doses (SAD) of OCR 002 administered as intravenous (IV) infusions in healthy volunteersTo evaluate the plasma pharmacokinetics (PK) of phenylacetate and ornithine and glutamine after a…
Primary objective:* To demonstrate that subjects who receive an 8-day series of Otelixizumab infusions have greater improvement than subjects who receive placebo in endogenous insulin secretion at 12 months after study drug administration. Secondary…
to confirm that GMC 252 is absorbed in humansto determine in humans whether GMC 252 is cleaved, yielding diflunisal and N-acetylcysteine (NAC)to determine whether additional metabolites are formed with GMC-252 compared with diflunisal and NAC
- to evaluate the safety and tolerability of oral ANA773 tosylate (ANX8414) administered with ribavirin inpatients with chronic hepatitis C viral (HCV) infection· to evaluate the anti-viral and pharmacodynamic effects of ANA773 tosylate (ANX8414)…
The primary objectives of this study are the following:• To evaluate the safety and tolerability of DMOT4039A when administered every 3 weeks or weekly to patients with unresectable pancreatic or platinum-resistant ovarian cancer• To determine the…
The primary objective of this trial will be to evaluate the effect of ONO-2506PO (1200 mg once daily) on the slope of respiratory function (slow vital capacity (SVC) expressed as a percentage of the predicted value) over 12 months compared with…
To evaluate the efficacy of ACZ885 plus MTX by assessing the response to treatment (ACR50) as compared to MTX alone in early RA patients after 6, 14 and 26 weeks of treatment. The study aims to evaluate the clinical response in this RA subpopulation…
The primary objective is to establish the neuroprotective efficacy of NAC against cisplatin-induced neurotoxicity. Mainly the sensory neuronal guidance will be assessed before and after treatment with cisplatin in a group of patients receiving NAC…
1. Determine the influence of acetylcysteine on thiopuirine related hepatotoxicity2. Determine the relation between hepatotoxicity, thiopurine metabolism, amino acid availablility and markers for oxidative stress3. Determine the effect of…
Primary Objective:To assess the clinical response rate as measured by American College of Rheumatology 20% (ACR20) response rate at Week 12.Secondary Objective:• To assess:- for all patients at Week 12, and every 8 weeks and at the completion/…
The goals of the proposed study are: (1) to further elucidate the relations between impulse control, motivational strength of drug cues, and brain activation patterns (using fMRI); (2) to examine the relative strength by which these processes are…
To demonstrate that oral administration of apixaban 2.5 mg BID for 30 days reduces the rate of total venous thromboembolism (VTE) and VTE-related death compared to standard, subcutaneous administration of enoxaparin 40 mg QD for a recommended…
The primary objective of this trial is to compare the effect of three different doses of ONO-8539 with placebo in the mean change of the number of micturitions per 24 hrs from baseline to 12 weeks.The secondary objectives of this trial will be:*To…
Primary:* To demonstrate non-inferiority between the level of agreement in diagnosis (i.e. patient classification of normal, mild/moderate or severe ischemic disease based on the number of reversible perfusion segments) between sequential adenosine…
Primary Objective: Our primary objective is to investigate the effect of NAC on H2S levels in plasma in different patient groups, i.e. healthy volunteers, CKD patients, and dialysis patients. We hypothesize that there is an increase in H2S levels…