110 results
Objectives:Primary:• To determine the absolute bioavailability of niraparib by using an intravenous (IV) niraparibmicrodose of 100 µg (containing approximately 1 µCi of [14C]-niraparib) in subjects with cancer.Secondary:• To characterize the…
The primary objective of the study is Study to determine the Safety, Tolerability, Pharmacokinetics and Effect on Circulating Alpha-1 Antitrypsin Levels of ARC-AAT in Patients with Alpha-1 Antitrypsin Deficiency (AATD)
The primary objective of the study is to assess the safety and tolerability of long-term open-label CP-690,550 therapy in subjects with CD.Secondary objectives are to evaluate the effect of CP-690,550 maintenance therapy on clinical remission and on…
The purpose of this studie is to evaluate the bioequivalence of canagliflozin.
Primary ObjectivePhase Ia* To determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D)and assess the safety of single agent GDC-0810 in postmenopausal women with locally advanced or metastatic estrogen-receptor-positive (ER…
Primary objectiveTo determine whether the clinical response after 10-day oral administration of cadazolid is non-inferior to oral vancomycin in subjects with CDAD.Secondary objectivesTo determine whether oral administration of cadazolid for 10 days…
The primary objectives of this study are:1. To evaluate the safety and tolerability of PTG-1002. To evaluate the efficacy of PTG-100 in the induction treatment of subjects with moderate to severe active UC compared to placebo.The secondary…
The primary objective of this study is to assess the noninferiority of ALXN1210 compared to eculizumab in adult patients with PNH who have never been treated with a complement inhibitor. Noninferiority will be claimed if after 26 weeks of treatment…
The primary objectives of this study are:* To evaluate tracer kinetic models for the purpose of quantifying specific binding of 18F-AV-1451 in cross sectional and longitudinal applications; and* To evaluate simplified methods for quantification of…
The primary objective of this confirmatory study is to confirm the acid neutralisation action of Gaviscon Double Action Liquid versus placebo liquid, within the stomach.
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…
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…
- 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)…
Primary objective:- To evaluate the safety and tolerability of single ascending doses of ASP3652 in healthy young Caucasian male and female subjectsSecondary objectives:- Different pharmacokinetic outcomes- Different pharmacodynamic outcomes
The primary objective is:Assess the efficacy defined as Composite Complete Response (CRc)The secondary objectives of this study are:* Assess safety and tolerability* Assess immunogenicity and pharmacokinetics* Progression-free survival (PFS),…
The evaluation of the safety and pharmacokinetics of ABT-414 in combination with radiation plus temozolomide or temozolomide alone for subjects with Glioblastoma Multiforme.
To assess the long-term safety and tolerability of selexipag (ACT-293987) in patients with pulmonary arterial hypertension (PAH).
To evaluate the efficacy of AMG 181 as measured by the proportion of subjects achieving Crohn*s Disease Activity Index (CDAI) remission (CDAI < 150) at week 8.
Primary Objective To evaluate the efficacy of ProCervix adjuvanted with imiquimod, in comparison with placebo adjuvanted with imiquimod, to induce HPV 16 and 18 viral clearance at 12 months in HPV 16 and/or 18 infected women using a type specific,…
Primary objectiveThe primary objective of the study is to estimate the effects of tofacitinib in maintaining a clinical response or being in remission in subjects with moderate to severe Crohn*s disease previously achieving clinical response or…