22 results
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 current study is to evaluate the efficacy and safety of the 3-day oral aprepitant regimen when administered concomitantly with ondansetron, with or without dexamethasone, in pediatric patients, from 6 months to 17 years of age,…
The primary objective is to evaluate the effect of a once-a-weekprophylaxis regimen with BAY 79-4980 on the protection from all bleeds compared to a three times-per-week prophylaxis regimen with rFVIII-FSWFI.
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…
Primary Objective: - to study the influence of administration aprepitant (Emend ®) on the clearance of fentanyl, in patients using a stable dose of the fentanyl patch (Durogesic ®).Stable dose is defined as using the same dose of fentanyl during at…
The question is whether aprepitant should be added to CE cycles (cisplatin containing regimen with etoposide) because of a possible interaction between aprepitant and etoposide.This question derives from the fact that both drugs are metabolised…
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.
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…
To assess safety, tolerability and pharmacokinetics of a single subcutaneous administration of HPV-NIRD1.
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…
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…
The co-primary objectives of this study are: * To evaluate the efficacy of as measured by investigator-assessed PFS according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). * To evaluate the efficacy of atezolizumab as…
To evaluate the effect of prolonged duration of (fos)aprepitant prophylaxis on the prevention of delayed CINV (complete remission in the 24-72 hours after the final dose of chemotherapy) in children. The current 3-day regimen is compared to a…
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 (…
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…
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…
To investigate the influence of aprepitant on the exposure to etoposide in TC patients treated with (B)EP.