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Phase IIa, Double-Blind, Placebo-Controlled, Study of ESN364 Administered for 12 Weeks to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Women Presenting With Polycystic Ovarian Syndrome

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…

A Phase 2a Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Multi-center Study Investigating the Safety and Tolerability of JNJ-54861911 in Subjects in the Early (Predementia) Alzheimer*s Disease Spectrum

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.

A Phase II, 12-week, double-blind, randomised, parallel group, multi-centre, international trial to assess the effect on glycaemic control of five doses of HM11260C versus placebo or open-label liraglutide in subjects with type 2 diabetes

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…

A Double-blind, Placebo-Controlled, Randomized, 4-Week, Multiple-Dose, Proof-of-Mechanism Study in Subjects with Early Alzheimer*s Disease Investigating the Effects of JNJ-54861911 on Aß Processing in CSF and Plasma

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…

A Multiple Dose Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of MK-8408 in Subjects with Hepatitis C Infection

-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…

Randomized, single-blind, placebo controlled multicenter phase III study to assess the efficacy and safety of expanded autologous adipose-derived stem cells (eASCs) (CX-401), for treatment of complex perianal fistulas in Crohn*s disease.

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).

A Phase 3, Randomized, Double-Blind, Multinational, Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab (MGA031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adults with Recent-Onset Type 1 Diabetes Mellitus

Primary: The primary objective of this study is to assess relative to placebo, the efficacyof teplizumab when administered according to 3 different teplizumab dosing regimens in subjects with recent-onset T1DM (within 12 weeks of presentation of…

Multicenter, randomized, double-blind, phase III trial to investigate the efficacy and safety of oral BIBF 1120 plus standard pemetrexed therapy compared to placebo plus standard pemetrexed therapy in patients with stage IIIB/IV or recurrent non small cell lung cancer after failure of first line chemotherapy

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.

A Phase 2/3, Randomized, Double-Blind, Multicenter, Multinational, 4-Arm,
Controlled, Dose-Ranging Study to Evaluate Efficacy and Safety of Teplizumab
(MGA031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in
Children and Adults with Recent-Onset Type 1 Diabetes Mellitus

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…

An explorative, randomized, placebo-controlled, double-blind, parallel-group trial, to evaluate the pharmacodynamic effect of M0003 on reflux parameters in subjects with gastroesophageal reflux disease and with persistent symptoms despite taking a stable dose of proton pump inhibitors.

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…

A human phase 0, microdose pharmacokinetic study of [14C]-Org 201745-0, [14C]-Org 244378-0 and [14C]-Org 245021-0 in post-menopausal female volunteers

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…

A Double-Blind, Placebo-Controlled, Randomised, Parallel Group Phase IIa
Study to Evaluate the Histological Changes, Cellularity, Clinical Efficacy
and Safety of AZD1981 in Patients with Moderate to Severe Chronic
Obstructive Pulmonary Disease (COPD)

The aim of this study is to assess the effect of AZD1981 on histology (lung tissue biopsy) and inflammatory cells (broncho alveolar lavage [BAL] and induced sputum), symptoms, lung function, exercise tolerance and on inflammatory mediators in sputum…

A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE I STUDY TO DETERMINE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF SINGLE ASCENDING ORAL DOSES OF P1201-07 IN HEALTHY OVERWEIGHT OR OBESE SUBJECTS

To determine the safety and tolerability of P1201-07 administered as single ascending oral doses in overweight or obese but otherwise healthy subjects.

A SINGLE AND MULTIPLE ASCENDING DOSE TRIAL INVESTIGATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF ORALLY ADMINISTERED SP-35454 IN HEALTHY POSTMENOPAUSAL WOMEN

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-…

A Phase I, single-center, open-label, randomized four-period, randomized five-period or randomized two period crossover study to investigate the pharmacokinetics of five different DMF-containing formulations of FP187 and the comparator products Tecfidera® and Fumaderm® in healthy volunteers after oral administration in fasted or fed state

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…

Phase I , single-center, open-label, two-period study to investigate the pharmacokinetics of the DMF-containing formulation FP187-GC in healthy volunteers after oral administration in fasted and fed state

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…

A Phase I, open label, randomized, crossover trial in healthy subjects to investigate the pharmacokinetic interaction between didanosine and TMC114, coadministered with low-dose ritonavir, at steady-state.

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…

A randomized, double-blindphase 3 study of vadastuximab talirine (SGN-CD33A)versus placebo in combination with azacitidine or decitabine in the treatment of older patients with newly diagnosed acute myeloid leukemia (AML)

Primary* To compare the composite complete remission (CRc) rate (morphologic complete remission [CR] and morphologic CR with incomplete hematologic recovery [CRi]) between treatment arms * To compare overall survival (OS) between treatment…

Phase I, single-center, open-label, two-period study to investigate the pharmacokinetics of the DMF-containing formulation FP187-V2B in healthy volunteers after oral administration in fasted and fed state

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…

A 2-Part Randomized, Placebo-Controlled, Double-Blind, Single and Multiple Ascending Dose Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-63733657 in Healthy Subjects and Subjects With Alzheimer*s Disease

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…