27 results
-To identify a safe dose of MK-8408 in HCV infected patients that mediates a 3Log10 reduction-To evaluate safety and tolerability of MK-8408 administered for 5 consecutive days-To evaluate the plasma pharmacokinetic profile of multiple oral doses of…
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…
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.
The primary objective of the study is:To evaluate efficacy of two doses of ESN364 versus placebo when administered for 12 weeks to decrease total testosterone (TT) levelsThe Secondary objectives are:To evaluate effect of two doses of ESN364 versus…
To investigate the efficacy and safety of BIBF 1120 as compared to placebo in patients with stage IIIB/IV or recurrent non small cell lung cancer treated with standard therapy of pemetrexed after failure of first line chemotherapy.
To assess indacaterol (300 and 600 ug once daily via SDDPI) superiority in patients with COPD as compared to placebo with respect to 24 h post dose (through) FEV1 after 12 weeks of treatment.
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 the trial are:1. To investigate the tolerability and safety of SP-35454 following single and multiple dose oral administration.2. To investigate the single and multiple dose pharmacokinetics of SP-35454 and its metabolite SP-…
Primary objective* To investigate the plasma pharmacokinetics of the first metabolite of dimethyl fumarate (DMF) - monomethyl fumarate (MMF) - following administration of the delayed- and slow-release FP187-GC tablet formulation after single dose…
Part IPrimary objectiveTo investigate the pharmacokinetics of the main metabolite of dimethyl fumarate (DMF) - monomethyl fumarate (MMF) - following administration of 3 different controlled release tablet formulations (FP187: V1, V2B, and V3B) and…
Primary:The primary objective of this study is to assess, relative to placebo, the efficacy, tolerability, andsafety of teplizumab when administered according to 3 different teplizumab dosing regimens insubjects with recent-onset (onset within past…
The primary objective of the study is to evaluate the efficacy of intralesional administration of eASCs (CX-401) when added to standard surgical care and drainage for the treatment of complex perianal fistulas in patients with Crohn*s disease (CD).
To determine the safety and tolerability of P1201-07 administered as single ascending oral doses in overweight or obese but otherwise healthy subjects.
Primary objective* To investigate the plasma pharmacokinetics of the first metabolite of dimethyl fumarate (DMF) - monomethyl fumarate (MMF) - following administration of the delayed- and slow-release FP187-V2B tablet formulation after single dose…
This will be the first study with JNJ-63733657 in humans to investigate the safety, tolerability and pharmacokinetics of JNJ-63733657 and to explore potential pharmacodynamic (PD) effects in healthy subjects following single dose administration and…
Primary objectives: • To determine the safety and tolerability of a single administration and single-day IDR of intravenous GH002.• To determine the pharmacokinetics (PK) of 5-MeO-DMT in healthy volunteers following a single administration and…
PrimaryTo determine the pharmacologically optimal dose of ALRN-6924 to induce transient cell cycle arrest in human bone marrow and other tissues.SecondaryTo characterize relative to ALRN-6924 administration the time to onset, the magnitude, and the…
Primary Objective:• To evaluate event-free survival (EFS) after blinatumomab when compared to standard ofcare (SOC) chemotherapySecondary Objective(s):• To evaluate the effect of blinatumomab on overall survival (OS) when compared to SOCchemotherapy…
Primary ObjectiveTo determine if JNJ-56021927 plus gonadotropin releasing hormone (GnRH) agonist in subjects with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy (RT) results in an improvement of…