8 results
The study will be performed in 3 parts, Parts 1, 2 , 3. and 4 (DDI). The purpose of the study is to investigate how safe the compound is and how well the compound is tolerated; this will be investigated in all study parts. In Parts 1 and 2, it will…
Primary Objective: to investigate the effect of rosuvastatin 20 mg qd on subsequent immune activation markers in treatment-naïve HIV-patients: circulating LPS (LAL assay), TLR mRNA expression in whole blood, circulating IL-6, D-dimer, hsCRP, CD38…
Primary:To assess the safety and tolerability of single and multiple oral ascending doses of the study drug in healthy human subjects (Part 1 and Part 2)To assess the effect of food on the absorption and pharmacokinetic (PK) profile of the study…
Primary objective: To explore whether prolonged moderate alcohol consumption affects in vivo cytokine response after a low dose of LPS in young, normal-weight men.Secondary objectives: To explore whether prolonged moderate alcohol consumption-…
The primary objective is to investigate the effects of intravenous administration of C1INH in human volunteers on cytokine release (TNFa) during endotoxemia. The secondary objective is to determine the effect of administration of C1 INH on…
Primary objectives: Stress response: To determine whether acute alcohol consumption shortly after a psychological/mental stressor attenuates the stress response recovery.Cholinergic status: To determine whether prolonged moderate alcohol consumption…
Primary ObjectiveTo relate microbiome modulation by dietary fibre supplementation, as measured by 16S rRNA sequencing, to changes in response to a mixed-meal metabolic challenge (PhenFlex) as measured by composite biomarker score.Secondary…
Primary objectives: to evaluate the efficacy of three different single doses of PHA-022121 versus placebo in achieving angioedema symptom relief during acute attacks and the efficacy of prophylactic treatment with PHA-022121 versus placebo in…