56 results
The primary purpose of the study is to investigate how quickly and to what extent traces of metals that are naturally present in Smecta® could be absorbed and eliminated from the body (this is called pharmacokinetics). For exploratory purposes, the…
Primary objective- To determine safety and tolerability of a single dose of cRGD-ZW800-1 in healthy volunteers.Secondary objectives- To determine the pharmacokinetics of a single dose of cRGD-ZW800-1 by measuring the fluorescence of blood and urine…
4.1 Primary• To estimate the Sensitivity and False Positive rate of OTL38 for malignancy detection during Near Infrared Imaging (NIR).• To assess the safety and tolerability of single intravenous doses of OTL384.2 Secondary• To assess the safety of…
- To evaluate the pharmacokinetic (PK) parameters (AUC0-t, AUC0-*, Cmax, C24, Tmax, and apparent t1/2) of MK-3682 and its circulating metabolites (IDX20664 and IDX23267), MK-5172, and MK-8408 following administration of the fixed-dose combinations…
- to evaluate the pharmacokinetic (PK) parameters (AUC0-t, AUC0-*, Cmax, C24, Tmax, and apparent t1/2) of MK-3682 and its circulating metabolites (IDX20664 and IDX23267), MK-5172, and MK-8408 following administration of the fixeddose combination…
Primary Objective: - to evaluate the pharmacokinetic (PK) parameters (AUC0-t, AUC0-inf, Cmax, C24hr, Tmax, and apparent t*) of MK-3682 and its circulating metabolites (IDX20664 and IDX23267), MK-5172, and MK-8742 following administration of two…
Primary ObjectiveTo evaluate and compare the pharmacokinetic (PK) parameters (AUC0-t, AUC0-inf, Cmax, C24hr, Tmax, and apparent t*) of MK-3682 and its circulating metabolites MK-5172, and MK-8742 following administration of three test premarket…
The main purpose of this study is to investigate the effect of multiple doses of PHA-022121 on how quickly and to what extent a drug cocktail (a combination of agents consisting of caffeine, omeprazole, and midazolam) is absorbed, distributed,…
The objectives of this exploratory study are: * To evaluate the safety and local tolerability of the new flurbiprofen 8.75 mg spray. * To compare the pharmacokinetic profile of the new flurbiprofen 8.75 mg spray to marketed flurbiprofen 8.75 mg…
* To evaluate the effect of EDP1815 on the systemic immune system.* To evaluate the safety and tolerability of EDP1815 in multiple formulations.
The overarching goal of this study is to improve adequate resection of oral cancer. We will perform a clinical trial to determine the optimal dose of cRGD-ZW800-1 and to investigate the feasibility of intraoperative FLI to adequately assess tumor…
Primary:- To evaluate the safety and tolerability of NT-0167 in healthy volunteersSecondary:- To evaluate the pharmacokinetic (PK) profile of NT-0167 in healthy volunteers after the administration of single ascending (SAD) and multiple ascending…
The purpose of this study is to provide remdesivir (RDV) to participants with moderate COVID-19. The primary objective of this study is as follows: To evaluate the efficacy of 2 remdesivir (RDV) regimens compared to standard of care (SOC), with…
Primary Objective:* To evaluate the effect of EDP-305 on alkaline phosphatase (ALP) levels.Secondary Objective:* To evaluate the safety and tolerability of EDP-305* To evaluate the effect of EDP-305 on bilirubin levels* To evaluate the effects of…
Primary Objective: To characterize the effect of repeat-dose administration of brigatinib 180 mg QD on the single-dose PK of midazolam.Other Objectives:Safety: To assess the safety and tolerability of brigatinib in patients with ALK-positive or ROS1…
Primary Objective• To evaluate the local safety and tolerability of INM-755 cream following repeated once-daily topical applications for 14 consecutive days on wounded skin of healthy volunteers. Secondary Objectives• To evaluate the systemic safety…
The primary objective of this study is as follows: -To evaluate the efficacy of 2 remdesivir (RDV) regimens with respect to clinical status assessed by a 7-point ordinal scale on Day 14The secondary objective of this study is as follows: - To…
Primary ObjectivesTo evaluate the safety and tolerability of AP30663 in healthy males at doses up to 12mg/kgExploratory ObjectiveTo evaluate the effect of AP30663 on electrocardiographical parameters.
Primary Part 1: To investigate the effect of multiple oral doses of rifampicin on the pharmacokinetics (PK) of a single oral dose of RO7017773 in healthy participants.Part 2: To investigate the effect of multiple oral doses of gemfibrozil on the PK…
Primary Objectives1. To assess pruritus and rash after administration of Neublastin or placebo in healthy subjects and migraine patients (Parts A and B)2. To assess headache and other migraine-associated symptoms after administration of Neublastin…