21 results
PRIMARY OBJECTIVES Part I - To evaluate the efficacy (as measured by PFS) of GDC-0941 340 mg +carboplatin * paclitaxel (Arm A) versus carboplatin * paclitaxel (Arm B) in all patients with squamous NSCLC -To evaluate the efficacy (as measured by PFS…
To assess safety, tolerability and pharmacokinetics of a single subcutaneous administration of HPV-NIRD1.
Primary Objective: The primary objective is to determine whether the administration of Gelofusine will reduce the kidney uptake of 111In-labeled exendin in humans by enhancing the excretion of 111In-labeled exendin. These highly relevant data can…
The purpose of this study is to see if JNJ-42847922 is useful for treating patients with insomnia without any other psychiatric disease. The safety of JNJ-42847922 will also be studied.
To evaluate the effects of JNJ-42847922, compared to zolpidem and placebo, on driving performance as assessed by the mean difference of standard deviation of lateral position (SDLP) after forced awakening using a validated driving simulator test at…
Primary Objective:To investigate the safety and tolerability of JNJ-42847922 in subjects with MDD. Study medication will be administered for 10 days in women of childbearing potential (WOCBP) or for 4 weeks in all other subjects.Secondary Objectives…
Primary ObjectiveTo evaluate the effect of JNJ-42847922 on sleep latency (latency to persistent sleep [LPS]) in MDD subjects, stably treated with an SSRI/SNRI, who suffer from insomnia.Secondary Objectives* To investigate the safety, tolerability,…
To investigate how quickly and to what extent diclofenac is absorbed and eliminated from the body (this is called pharmacokinetics) when it is administrated by using a HP 5000 transdermal patch. Furthermore, the pharmacokinetics of HP-5000…
1. To identify and quantify the structural airway wall layers with OCT and rEBUS and correlate this to histology and HRCT2. To identify and quantify the effect of bronchial thermoplasty on the airway wall layers by OCT and rEBUS and correlate this…
To assess the safety and tolerability of escalating single IV doses of NI-0801.To determine the pharmacokinetics and pharmacodynamics parameters of escalating single IV doses of NI-0801.
Main objectives: safety and efficacy of BAY94-9027 for prophylaxis and treatment of bleeding in PTP with hemophilia ASecondary objective: PK
The purpose of this study is to investigate how quickly and to what extent different doses of EUapproved Tysabri® are absorbed and eliminated from the body (this is called pharmacokinetics) and how the body responds to different doses of Tysabri (…
1. To evaluate the safety and tolerability of ascending multiple oral doses of HTL18318 in healthy adult male and female subjects.2. To evaluate the pharmacokinetics of ascending multiple oral doses of HTL18318 in healthy adult male and female…
The primary objectives of this study are:• To determine whether ART-123, when administered to subjects with infection complicated by at least one organ dysfunction and coagulopathy, can reduce mortality.• To determine the safety of ART-123 in this…
The primary objective is to correlate ex vivo 111In-exendin tracer accumulation in the pancreas of patients undergoing pancreatectomy for pancreatic cancer or chronic pancreatitis to establish the relation between tracer uptake and beta cell mass in…
The objective of this study is to assess the efficacy and safety of adalimumab in combination with a topical treatment for the treatment of patients with moderate to severe chronic plaque psoriasis.
The primary objectives of this study is:* To determine the safety and tolerability of rhHNS via ascending doses administered via a surgically implanted intrathecal drug device (IDDD) once monthly for 6 months, in patientswith MPS IIIA.The secondary…
Primary Objective: To compare the fate of the struts in front of the side-branch and intimal bridge formation after treatment with optical coherence tomography between the bioresorbable everolimus eluting vascular scaffold and XIENCE family…
Primary Objective:To compare the fate of the struts in front of the side-branch and intimal bridge formation using optical coherence tomography after treatment with the bioresorbable everolimus eluting vascular scaffold of coronary bifurcation…
Primary Objective: Compare the uptake of 68Ga-NODAGA-exendin-4 in the liver between T1D patients with functional islet grafts (C-peptide > 0.8 nmol/L after mixed meal stimulation test and relevant laboratory parameters as HbA1C and exogenous…