8 results
The primary objectives are:* to determine the effect of steady-state concentrations of TMC114 coadministered with a lowdose of ritonavir on the steady-state pharmacokinetics of ddI,* to determine the effect of steady-state concentrations of ddI on…
1)To assess the preliminary pharmacokinetics of [14C]-Org 201745, [14C] Org 244378 and [14C] Org 245021 when administered as a sub-therapeutic dose by the oral route to healthy post-menopausal female volunteers.2) To evaluate the safety and…
The objectives of this exploratory trial are:1. To measure the pharmacodynamic (PD) effect on parameters derived from 24-hpH/impedance (MII) monitoring,2. To explore the effect on symptoms,3. To evaluate the safety and tolerabilityof treatment with…
The aim of this study is to evaluate androgen receptor (AR) and estrogen receptor (ER) expression non-invasively by means of PET imaging with the tracers 18F-FDHT and 18F-FES. To verify the PET results, the standard diagnostic biopsy will be…
Primary Objectives•To assess and compare the efficacy of five doses of HM11260C (once weekly subcutaneous injections) over the 12 weeks from baseline in comparison with placebo (once weekly subcutaneous injections) on glycaemic control, as assessed…
This proof-of-mechanism (POM) study in subjects with early AD, being subjects asymptomatic at risk for AD and subjects with pAD, is performed to confirm a drug interaction with the intended enzyme (BACE) at the intended target location (brain) by…
Primary objective: to explore 18F-FDHT PET/CT as a predictor of response in patients with metastasized CRPC to be treated with enzalutamide. Secondary objective: to explore 18F-FDHT PET/CT as a predictor of clinical survival endpoints in patients…
This safety study in subjects in the early (predementia) AD spectrum is performed to investigate primarily the safety and tolerability of JNJ-54861911 during 6 months of treatment.