43 results
2.1 Primary objectiveTo assess the rate of no progression (NPR) at 8 weeks following treatment with the combination of gefitinib and fulvestrant in EGFR mutated patients who failed previous treatment with reversible EGFR TKI*s (gefitinib or…
The primary objective of the study is to evaluate whether the addition of LABA to ICS therapy (FSC) is non-inferior to ICS therapy alone (FP) in terms of the risk of serious asthma related events (asthma-related hospitalization, endotracheal…
The primary objective is to evaluate whether the addition of a LABA to an ICS (FSC) therapy is non-inferior in terms of risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) compared with ICS…
(1) To assess [11C]phenytoin plasma and brain kinetics in healthy volunteer(s), including assessment of the presence of radioactive metabolites in plasma. (2) To develop a tracer kinetic model for [11C]phenytoin in humans. (3) To determine intra-…
Primary* To determine the maximum tolerated dose or recommended phase 2 dose of oral BYL719 as single agent and in combination with fulvestrantSecondary* To assess the overall safety and tolerability of BYL719 as single agent and in combination with…
Primary:to evaluate the safety and tolerability of single escalating intravenous (IV) doses of MORAb-022 in healthy subjects and subjects with rheumatoid arthritis (RA)Secondary:- to evaluate the pharmacokinetics (PK) of single escalating IV doses…
The purpose of the study is to investigate how safe the compound USL260 is and how well the compound USL260 is tolerated under fasting and fed conditions. The study will also investigate how quickly and to what extent the compound USL260 is absorbed…
In vitro data indicate that raltegravir is not a substrate of UGT1A4 or UGT2B7, but there is no evidence that raltegravir itself does not influence metabolism of other agents mediated by either UGT1A4 or UGT2B7.
The aim of this study is to quantify residual ER binding sites during fulvestrant therapy, compared to the tracer uptake prior to fulvestrant therapy.
Primary: To determine whether treatment with BKM120 plus fulvestrant prolongs PFS based on local investigator assessment compared to treatment with placebo plus fulvestrant for all patients regardless of PI3K pathway activation status (full…
Primary Objectives:* To determine the safety and tolerability of ENA-001 in healthy subjects after low and high doses of ENA-001 under hypoxic and hypercapnic conditions in conjunction with low and high doses of propofol.* To determine the…
• To assess effects of a single oral dose of 160 and 1500 mg cannabidiol compared to placebo on a specific set of pain modalities• To assess effects of a single oral dose of 160 and 1500 mg cannabidiol compared to placebo on UVB- and capsaicin-…
The main purpose of this study is to investigate the effect of nipocalimab on how quickly and to what extent etanercept or hydroxychloroquine is absorbed, distributed, metabolized and eliminated from the body. The study consists of 2 parts, Part 1…
- To evaluate the single-dose PK and pivotal bioequivalence of 3 compounds darunavir (DRV) 675 mg, FTC 200 mg, and tenofovir alafenamide (TAF) 10 mg in the presence of cobicistat (COBI)150 mg when administered as an fixed-dose combination (FDC) (D/C…
Lu AF28996 is an orally administered investigational compound of a potent, long-acting dopamine agonist, Lu AA40326, currently under development by H. Lundbeck A/S for the treatment of Parkinson*s disease (PD). Primary Objective:to investigate the…
Evaluate the efficacy of the ER-antagonist Fulvestrant in women with estrogen receptor positive (ER+) low grade gynecological cancers
The purpose of this study is to investigate how quickly and to what extent GS-4224 is absorbed and eliminated from the body. We study this when the study compound is administered alone and together with compounds that influence the activity of a…
The aim of this study is to determine the effects of propranolol on patients* crucial fear-related memories and dental trait anxiety in those undergoing surgical removal of one of their teeth or molars. The hypotheses that are tested are that…
Unless otherwise specified, efficacy objectives will be analyzed for the following two treatment comparisons:• Atezolizumab + carboplatin + nab-paclitaxel (Arm B) versus carboplatin + nab- paclitaxel (Arm C)• Atezolizumab + carboplatin + paclitaxel…
Primary: The primary objective is to determine whether treatment with alpelisib in combination with fulvestrant prolongs progression free survival (PFS) compared to treatment with placebo in combination with fulvestrant based on local radiological…