97 results
Our primary objective is:i. To assess the quantity and regional distribution of [18F]DPA-714 binding as a marker of microglial activation in patients with FTD compared to controls. Our secondary objectives are: i. To compare the quantity and…
- To assess the effects of single and multiple daily doses of 50 mg JNJ-54861911 once daily (q.d.) on the pharmacokinetics of caffeine, midazolam, and tolbutamide in healthy male subjects. - To assess the safety and tolerability of the concomitant…
Primary objective:* To assess the effect of vedolizumab SC maintenance treatment on clinical remission at Week 52 in subjects with moderately to severely active CD who achieved clinical response at Week 6 following administration of vedolizumab IV…
To determine the effect of a high-fat meal on the exposure to docetaxel given as ModraDoc006 tablets in combination with ritonavir in patients with cancer.
Primary objective:To determine the MTD/recommended dose for further study of oral LOXO-292 in patients with advanced solid tumors, including RET-fusion NSCLC, MTC, and other tumors with increased RET activity.Secondary objectives:* To determine the…
This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of MTAU9937A in patients with prodromal or mild Alzheimer*s disease (AD), ages 50*80, who are amyloid positive by cerebrospinal fluid (CSF) or amyloid positron…
* To determine the DLT and the MTD/RP2D of docetaxel as ModraDoc006/ritonavir that can be administered safely to patients with NSCLC in a bi-daily weekly schedule, following platinum doublet first-line treatment.
To compare the efficacy of Diacerein 1% Ointment to Control Ointment when applied once-daily in subjects with EBS.To compare the effects of Diacerein 1% Ointment to Control Ointment in subjects with EBS in:* Safety and tolerability* Pruritus * Pain…
The objective of the study is to compare conventional therapy with biological therapy in patients with early rheumatoid arthritis.
Primary objective: To demonstrate pharmacokinetic comparability of 3D-printed sildenafil tablets and the originator sildenafil tablets following a single 20 mg dose in healthy adult subjects.Secondary objectives:• To describe the plasma…
Primary: Evaluate the efficacy of patient-derived tumor organoids to successfully allocate patients for treatment with specific targeted agents.Secondary: Characterize safety and tolerability per experimental treatment regimen.
Improve allo-SCT transplant outcome using a uniform conditioning regimen and pacritinib pretreatment by means of the proportion of patients with a failure within 6 months post-transplant. Events that are considered a failure are: primary graft…
The primary objective is to determine whether the rate of severe toxicity (CTC grade 3 to 5) associated with fluoropyrimidine treatment can be significantly diminished by individualized dosing of fluoropyrimidines based on upfront genotypic…
The primary objective of this study is to proof the concept that cisplatin-induced ototoxicity can be prevented by transtympanic STS containing gel application, through inserted grommets.The STS containing and blank gel formulations will be provided…
Primary: To evaluate the long-term safety profile of BG00012.Additional: To evaluate the long-term efficacy of BG00012 using clinical endpoints (including relapse and annualized relapse rate [ARR]) and disability progression (Expanded Disability…
Primary Objective:To evaluate the safety and tolerability of FL-101 as monotherapy.Timepoint of evaluation of primary objective: From first dose to 3 months after surgerySecondary Efficacy Objectives1. Cohort 1: To evaluate the activity of FL-101…
Primary Objective:To evaluate the safety and tolerability of FL-101 as monotherapy and in combination with nivolumabTimepoint of evaluation of primary objective: From first dose to 3 months after surgerySecondary Efficacy Objectives1. Cohort 1: To…
To determine if emixustat hydrochloride (emixustat) reduces the rate of progression of macular atrophy (MA) compared to placebo in subjects with Stargardt disease (STGD)1. To evaluate the safety and tolerability of emixustat compared to placebo2. To…
Primary: - To assess the effect of TAK-861 on excessive daytime sleepiness (EDS) as measured by sleep latency from the Maintenance of Wakefulness Test (MWT).Please refer to the Study protocol for detailed description on the secondary Objective of…
In this study, we want to learn more about the effect and safety of Ceralasertib plus Durvalumab on the inhibition of tumour growth, and also to better understand NSCLC and associated health problems.We compare the effect and safety of Ceralasertib…