23 results
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…
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…
1. to investigate early haemodynamic alterations and endothelial function in young prehypertensive medical students; 2. to examine the possbility to improve these haemodynamic changes after exposure to an endothelial dependent (salbutamol) and…
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…
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.
PrimaryTo demonstrate the superiority of galcanezumab versus placebo in the prevention of migraine in an adolescent population (12 to 17 year-olds) with chronic migraineSecondary* To compare galcanezumab with placebo with respect to 50% response…
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…
Main Objective:To demonstrate the superiority of galcanezumab versus placebo in the prevention of migraine in (at least) 1 of the following populations with migraine: the overall pediatric population (6 to 17 year-olds) or the adolescent population…
The primary objective of this study is:• To evaluate whether selonsertib (SEL, previously known as GS 4997) can cause fibrosis regression and reduce associated complications in subjects with cirrhosis due to NASH. The secondary objective of this…
To evaluate the perioperative hemostatic efficacy of BAX 802 in male subjects with CHA with inhibitors to human factor VIII (hFVIII) undergoing major or minor elective surgical, dental, or other invasive procedures as determined by the Global…
The primary objective is to test the hypothesis that galcanezumab is superior to placebo in the prevention of migraine in patients with treatment-resistant migraine.The key secondary objective are:- To compare galcanezumab with placebo with respect…
To demonstrate superiority in the metastasis-free survival (MFS) of men with high risk NM-CRPC treated with apalutamide versus placeboSecondary Objective:To compare the overall survival (OS) of men with high risk NM-CRPC treated with apalutamide…
Primary- Part 1: To identify recommended Phase 2 doses and schedules (RP2Ds) for each combination.- Part 2: To characterize the safety of each RP2D for each combinationSecondary- To characterize the pharmacokinetics and pharmacodynamics of each…
The purposes of this trial are:• To find out the side effects (unexpected or unwanted reactions from taking a drug) when JNJ-64264681 and JNJ-67856633 are given in combination. • To find out how and at what dose(s) the combination of JNJ-64264681…
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…
The primary objectives for this study are:To evaluate the preventive effect of GYM329 on disuse muscle atrophy in healthy male volunteers through changes in muscle strength following a single subcutaneous administration prior to unilateral thigh and…
Primary ObjectivesPart 1:To characterize the safety and tolerability of single ascending doses of PTC518 in healthy subjects.Part 2:To characterize the safety and tolerability of PTC518 administered for 14 or up to 21 days in healthy subjects.Part 3…
PrimaryTo evaluate the safety and tolerability of single and multiple doses of TBAJ-587 in healthy participants.SecondaryTo determine the pharmacokinetics (PK) of single and multiple doses of TBAJ-587 and metabolites M2, M3 and M12. To compare the…