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The effects of propranolol on fear of tooth removal: A randomized, placebo-controlled, double-blind, parallel design trial

The aim of this study is to determine the effects of propranolol on patients* crucial fear-related memories and dental trait anxiety in those undergoing surgical removal of one of their teeth or molars. The hypotheses that are tested are that…

An open-label, single arm, Phase Ib/II study of AEB071 (a protein kinase C inhibitor) and everolimus (mTOR inhibitor) in patients with CD79-mutant or ABC subtype diffuse large B-cell lymphoma

Phase Ib:Estimate the maximum tolerated dose (MTD) and/or the recommended phase II dose (RP2D) of AEB071 and everolimus combination therapy inpatients with DLBCLPhase II:Assess the preliminary evidence for anti-tumor activity at R2PD for AEB071 and…

Multicentre, Open-Label Trial to Assess the Safety and Tolerability of LF111 (Drospirenone 4.0 mg) Over 6 Cycles in Female Adolescents, With a 7-Cycle Extension Phase

It is expected that LF111 will offer benefits to adults in the form of efficacy similar to COCPs, absence of estrogen-related risks, reduced tendency to weight gain and extended dosing window. It is likely that adolescents will share these benefits…

A phase Ib/II, open-label, multicenter study of AEB071 and MEK162 in adult patients with metastatic uveal melanoma

Phase Ib: Estimate the MTD and the RP2D of the combination of AEB071 and MEK162 in patients with metastatic uveal melanoma. And to assess the preliminary anti-tumor activity of the combination of AEB071 and MEK162. To characterize the PK profiels of…

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Escalating Doses of Intravenous WCK 4282 in Healthy Adult Human Subjects

To evaluate the safety and tolerability of multiple escalating doses of intravenous WCK 4282 in healthy, adult, human subjects.To evaluate the pharmacokinetics (PK) of multiple escalating doses of 1g:1g (1 vial) of intravenous (IV) WCK 4282 every 8…

A PHASE 1, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, MULTIPLE DOSE, PARALLEL ARM STUDY TO EVALUATE THE EFFECT OFMEAL TIMING AND FOOD- VERSUS THE FASTED STATE ON THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF REPETITIVE DAILY DOSES OF TONABERSAT (USL260) IN HEALTHY SUBJECTS

The purpose of the study is to investigate how safe the compound USL260 is and how well the compound USL260 is tolerated under fasting and fed conditions. The study will also investigate how quickly and to what extent the compound USL260 is absorbed…

Test-retest of the newly developed P-gp PET tracer [11C]phenytoin in healthy volunteers

(1) To assess [11C]phenytoin plasma and brain kinetics in healthy volunteer(s), including assessment of the presence of radioactive metabolites in plasma. (2) To develop a tracer kinetic model for [11C]phenytoin in humans. (3) To determine intra-…

A randomized double blind cross-over trial of the effects of low dose and high dose hydrocortisone replacement therapy on cognition, quality of life, metabolic profile and somatosensation in patients with secondary adrenal insufficiency

The aim of this study is to investigate whether a physiologically low hydrocortisone (HC) dose is better for cognition as compared to a high hydrocortisone dose. In addition, quality of life, metabolic profile and somatosensation will be described…

A Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation STUDY of MORAb-022 in Healthy SUBJECTS and Subjects with Rheumatoid Arthritis.

Primary:to evaluate the safety and tolerability of single escalating intravenous (IV) doses of MORAb-022 in healthy subjects and subjects with rheumatoid arthritis (RA)Secondary:- to evaluate the pharmacokinetics (PK) of single escalating IV doses…

The influence of Raltegravir (MK_0518) on the pharmacokinetics of single-dose Lamotrigine in healthy male subjects (GRANOLA)

In vitro data indicate that raltegravir is not a substrate of UGT1A4 or UGT2B7, but there is no evidence that raltegravir itself does not influence metabolism of other agents mediated by either UGT1A4 or UGT2B7.

A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-2

The objective of this clinical research study is to evaluate the safety and effectiveness of brodalumab, compared with ustekinumab and placebo, for the treatment of moderate to severe plaque psoriasis.

A Phase I study of AEB071, an oral protein kinase C inhibitor, in patients with metastatic uveal melanoma.

Estimate the maximum tolerated dose (MTD) of AEB071 (dose escalation) and characterize the safety and tolerability of the MTD or recommended Phase 2 dose of AEB071 in patients with metastatic uveal melanoma (dose expansion).

68Ga-DOTA-NOC PET/CT for the imaging of disease activity in neurologic and cardiac sarcoidosis.

The primary objective of this study is to evaluate the role of 68Ga-DOTA-NOC PET/CT in the imaging of disease activity in suspected neurological and cardiac sarcoidosis and to assess the sensitivity and specificity of 68Ga-DOTA-NOC PET/CT. We…

A PHASE III, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY EVALUATING THE EFFICACY AND SAFETY OF ATEZOLIZUMAB (MPDL3280A, ANTI-PD-L1 ANTIBODY) IN COMBINATION WITH CARBOPLATIN + PACLITAXEL OR MPDL3280A IN COMBINATION WITH CARBOPLATIN + NAB PACLITAXEL VERSUS CARBOPLATIN + NAB-PACLITAXEL IN CHEMOTHERAPY NAÏVE PATIENTS WITH STAGE IV SQUAMOUS NON-SMALL CELL LUNG CANCER

Unless otherwise specified, efficacy objectives will be analyzed for the following two treatment comparisons:• Atezolizumab + carboplatin + nab-paclitaxel (Arm B) versus carboplatin + nab- paclitaxel (Arm C)• Atezolizumab + carboplatin + paclitaxel…

A single-center, randomized, double-blind, two-period cross-over study to investigate the effect of rifampicin on the pharmacokinetics of clazosentan in healthy male subjects.

The purpose of the study is to determine how a single administration of rifampicin influences the uptake and breakdown of clazosentan. Furthermore, the safety and tolerability of clazosentan when administered after administration of rifampicin, will…

A phase 1, open-label, single-center study of absorption, metabolism and excretion and absolute bioavailability in humans of leriglitazone (MIN-102) in 2 parallel cohorts of male healthy subjects

In this study we will investigate how safe the compound leriglitazone is and how well it is tolerated when it is used by healthy participants.Apart from extensive laboratory and animal testing, leriglitazone has been used in the past both in healthy…

A PHASE III, OPEN-LABEL, RANDOMIZED STUDY OF ATEZOLIZUNAB (MPDL3280A, ANTI*PD-L1 ANTIBODY) IN COMBINATION WITH CARBOPLATIN + PACLITAXEL WITH OR WITHOUT BEVACIZUMAB COMPARED WITH CARBOPLATIN + PACLITAXEL + BEVACIZUMAB IN CHEMOTHERAPY-NAiVE
PATIENTS WITH STAGE IV NON-SQUAMOUS NON*SMALL CELL LUNG CANCER.

Primary Efficacy ObjectivesUnless otherwise specified, efficacy objectives will be analyzed for the following two treatment comparisons:• Atezolizumab + carboplatin + paclitaxel + bevacizumab (Arm B) versus carboplatin + paclitaxel + bevacizumab (…

A Phase 1, Single-blind, Randomized, Parallel-group Study in Healthy Participants to Investigate the Single-dose Pharmacokinetics, Safety and Tolerability of Rilpivirine After Subcutaneous Administration of a Rilpivirine Extended-Release Suspension alone, and of Rilpivirine and Cabotegravir After Co-administration with Cabotegravir Extended-Release Suspension

To characterize the single-dose pharmacokinetic (PK) of RPV after SC administration of RPV LA suspensions with different doses and/or different particle size (PS) to support further dose and formulation selection, in healthy adult participants.To…

A 3-Part, Randomized, Placebo-Controlled, Double-blind, Single Ascending Dose Study to Investigate
Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-55363932 in Healthy Participants.

Primary- To investigate the safety and tolerability of JNJ-55363932 after single oral dose administration(ascending dose levels) in healthy participants- To characterize the PK of JNJ-55363932 in plasma, cerebrospinal fluid (CSF) and urine…

Interventional, open-label, single- and sequential-ascending-dose study investigating the safety, tolerability and pharmacokinetic profile of Lu AF28996 in healthy young men.

Lu AF28996 is an orally administered investigational compound of a potent, long-acting dopamine agonist, Lu AA40326, currently under development by H. Lundbeck A/S for the treatment of Parkinson*s disease (PD). Primary Objective:to investigate the…