102 results
The purpose of the study is to investigate how quickly and to what extent balovaptan is absorbed and eliminated from the body when it is administered to healthy volunteers. The pharmacokinetics of balovaptan given by mouth (oral) will be compared…
The purpose of this study is to investigate how safe the new compound BMS-986337 is and how well it is tolerated when it is administered as single or multiple doses to healthy volunteers. BMS-986337 has not been administered to humans before. It has…
Phase 1• To determine the maximum tolerated dose (MTD) and RP2D of BLU 945 as monotherapy and in combination with osimertinib• To determine the safety and tolerability of BLU 945 as monotherapy and in combination with osimertinibPhase 2• To assess…
Primary:To provide access to abrocitinib to adolescent and adult patients with or without background topical therapy who have inadequate treatment options due to inadequate response or intolerance to available approved medicated topical and systemic…
Part 1:The purpose of this study is to determine whether LMTM inhibits monoamine oxidase (MAO). MAO is an enzyme (protein involved in reactions in the body) which breaks down tyramine. By giving participants tyramine which raises the blood pressure…
The purpose of this study is to investigate how quickly and to what extent HDM201 is absorbed, broken down and eliminated from the body (this is called pharmacokinetics). HDM201 will be labeled with 14-carbon (14C) and is thus radioactive. In this…
The purpose of the study is to investigate the effect of inarigivir on the absorption, distribution and elimination of midazolam in order to assess to what extent inarigivir may possibly change the pharmacokinetics of other drugs when given with…
The purpose of the study is to investigate how quickly and to what extent 2 different production batches of alpelisib (FMI and FMIopt) are absorbed and eliminated from the body (this is called pharmacokinetics). In this study it is investigated…
This study will compare the study compound Mentholatum 10% w/w Ibuprofen Gel to a similar product, which is already on the market in UK called Ibuleve Maximum Strength Gel. The purpose of the study is to compare these two gels in how quickly and to…
Primary objective:To evaluate the long-term safety of an as-needed treatment with twice-daily applications of delgocitinib cream 20 mg/g.Secondary objective:To evaluate the long-term efficacy of an as-needed treatment with twice-daily applications…
To assess safety and performance of the PerQseal® + Closure Device when used with the L PerQseal®Introducer to percutaneously close femoral artery punctures and to induce arterial haemostasis in patients undergoing endovascular procedures requiring…
• Allow patients to continue or start AP01 therapy for the treatment of ILD and IPF prior to regulatory approval or until the study is terminated• To evaluate safety outcomes of patients on AP01 therapy
Primary objective:To compare the efficacy with belantamab mafodotin vs pomalidomide plus low dose dexamethasone (pom/dex) in participants with relapsed/refractory multiple myeloma (RRMM)Secondary objectives:- To compare the overall survival with…
This study will evaluate the safety, tolerability, and pharmacokinetics of idasanutlin as a single agent and the safety, tolerability, pharmacokinetics, and preliminary efficacy of idasanutlin in combination with either chemotherapy or venetoclax in…
Primary end point• Progression-free survival (PFS) per ICR central assessmentSecondary end point• Objective response rate (ORR)• Disease control rate (DCR)• Overall survival (OS)• PFS according to Investigator assessment of radiologic images•…
Primair1. Assessment of the pharmacological activity of BAY·1834845 and BAY 1830839 on IMQ induced skin inflammation compared to placebo (prednisolone serves as active control), as quantified by laser speckle contrast imaging (LSCI, perfusion/basal…
This is a so-called *lead-in study* in which patients receive their standard treatment and no study treatment. The researchers will collect dataabout the patients* bleeding episodes, FVIII containing treatments used to prevent bleeding episodes and…
The primary objective is to estimate the average relative change from baseline in tumoruptake of [89Zr]Zr-BI 765063 (arm A) or [89Zr]Zr-BI 770371 (arm B) upon treatment with BI 765063 (arm A) or BI 770371 (arm B).
In this study we will investigate the pharmacodynamics of the compound Cofact, whereby the Cofact that will be used in this study is a modified version of the existing compound Cofact. The effect on the physiologic functions will be evaluated by…
Study IM011-127 is a Phase 2 randomized, double-blind, placebo-controlled, multicenter clinical study designed to assess the safety and tolerability, efficacy and biomarker response of BMS-986165 12 mg BID in subjects with moderate to severe…