105 results
The purpose of the study is to investigate how quickly and to what extent somapacitan is absorbed, metabolized (broken down) and eliminated from the body (this is called pharmacokinetics). Somapacitan will be labeled with tritium (3H, a radioactive…
The purpose of the study is to investigate how quickly and to what extent cenerimod is absorbed, distributed, metabolized (broken down) and eliminated from the body (this is called pharmacokinetics).
The main objectives of this study are:To evaluate the safety and tolerability of three oral dose levels of LTI-291 following 28 days of LTI-291 treatment in patients with GBA-PDTo characterize the plasma and CSF pharmacokinetics (PK) of LTI-291…
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…
In this study, we will investigate how safe the new compound AB521 is and how well it is tolerated when it is used by healthy participants. We will also investigate how quickly and to what extent AB521 is absorbed and eliminated from the body. In…
In this study we will investigate how safe the new compound seltorexant is and how well it is tolerated when it is used by healthy participants.We also investigate how quickly and to what extent seltorexant is absorbed, transported, and eliminated…
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…
Primary Objective1. To evaluate the efficacy of IMU-838 versus placebo as measured by quantitative magnetic resonance imaging (MRI) analysis for whole brain atrophy in progressive multiple sclerosis (PMS) patients with the Structural Image…
To determine the maximum tolerated dose (MTD) and Recommended Phase 2 Dose (RP2D) of RLY-4008 and to determine RLY-4008's safety and tolerability.
Primary objective: Single-ascending dose (SAD) and multiple-ascending dose (MAD) phases of the study: *To establish the safety and tolerability of single- and multiple-ascending dose(s) of KHK6640, respectively, in subjects with prodromal Alzheimer*…
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…
PrimaryTo evaluate the efficacy of fezolinetant 45 mg versus placebo on the frequency of moderate to severe VMSKey secondaryTo evaluate the efficacy of fezolinetant 45 mg versus placebo on the severity of moderate to severe VMSSecondary• To evaluate…
• 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
In this study we will investigate biomarkers in blood after exposure to heparin in the fasted state or after a high-fat meal. Biomarkers are proteins present in the blood. The biomarkers investigated in this study are proteins that are involved in…
The primary objective of this study is to assess the efficacy of MEDI4736 treatment compared with placebo in terms of overall survival (OS) and progression free survival (PFS; (per RECIST 1.1 as assessed by the investigator).
Double-blinded part:The primary objectives of the study are as follows:• To investigate the safety and tolerability of 28 days of oral doses of SAR443060 in subjects with ALS.The secondary objectives of the study are as follows: • To characterize…
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 how safe specific doses of the compound paltusotine are and how well these are tolerated when they are used by healthy participants.We also investigate how much of the compound is broken down and absorbed in the…
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…