26 results
To determine and compare PK profiles of two of the most used ROOs in cancer patients: one intranasal fentanyl formulation (INFC, Instanyl®) and one sublingual fentanyl formulation (SLF, Abstral®).
Primary Objective: - To study the effect of mucositis on the absorption of sublingually delivered fentanyl (Abstral®) in head and neck cancer patients treated with chemoradiotherapy. Secundary Objective:- To study the effect of xerostomia on the…
Primary ObjectivesPart 1 * Single Ascending DoseThe primary objective of the single ascending dose (SAD) part of the study is to characterize the safety and tolerability of a single dose of PTC857 in healthy subjects.Part 2 * Multiple Ascending…
Primary ObjectiveTo assess the tolerability and safety of single ascending oral doses of PHA-022121 administered after a standard meal and of a single 40 mg dose under fasted conditions in healthy adult subjects.To assess the PK characteristics of…
Part 1 - Single Ascending Dose (SAD):Primary objective:• To evaluate the safety and tolerability of single oral doses of THB001 in healthy subjects.Secondary objectives:• To characterize the plasma pharmacokinetic (PK) profile of single oral doses…
Primary objective:• To assess the mass balance of nanatinostat (ie, evaluate clearance mechanisms of nanatinostat and drug-related metabolites) following a single oral dose of [14C]-nanatinostat in patients with advanced cancer.Secondary objectives…
Primary objective:• To evaluate the safety and tolerability profile of single intravenous doses of AST-004 given as a short loading intravenous infusion followed by a 6-hour continuous intravenous (IV) infusion in healthy adult subjects.Secondary…
Primary:• To assess the effects of VMX-C001 and a DOAC on the anticoagulant effect of unfractionated heparin in healthy subjects.Secundary:• To assess the safety and tolerability of VMX-C001 in a simulated emergency use setting.• To assess the…
PrimarySAD: - To evaluate the safety and tolerability of single ascending doses of ANX1502 in healthy participants.MAD: - To evaluate the safety and tolerability of multiple ascending doses of ANX1502 in healthy participants.SecondarySAD: - To…
Primary:To evaluate the efficacy of depemokimab 200 mg SC every 26 weeks compared with mepolizumab 300 mg SC every 4 weeks in participants with relapsing or refractory EGPA receiving SoC therapySecondary:- To evaluate the efficacy of depemokimab 200…
Primary objectives: • To determine the safety and tolerability of a single administration and single-day IDR of intravenous GH002.• To determine the pharmacokinetics (PK) of 5-MeO-DMT in healthy volunteers following a single administration and…
Part 1:Primary objective:• To evaluate the PK profile of a single oral dose of ESB1609 jetmilled Form A in plasma and compare this profile with the PK profile of ESB1609 monohydrate Form B with 30% SLS.• To compare the PK profile of different…
Primary objective:• To investigate the effect of THB001 on the pharmacokinetics (PK) of caffeine, omeprazole and midazolam.Secondary objective:• To evaluate the safety and tolerability of THB001 co-administered with caffeine, omeprazole and…
Primary objective: To evaluate the safety and tolerability of single ascending i.v. doses of OMN6 in healthy young and elderly adult subjects.Secondary objective: To evaluate OMN6 PK in plasma following single ascending i.v. doses in healthy young…
Primary:1. To characterize the safety and tolerability of multiple oral doses of K-196 alone and in combination with naproxen/omeprazole in healthy subjects.Secondary:1. To assess the effects of K-196 compared to placebo on the proportion of…
Part 1 SAD:Primary objective: To evaluate the safety and tolerability of single ascending doses of ANXV in healthy subjects.Secondary objective: To determine the PK profile of single ascending doses of ANXV in healthy subjects.Part 2 MAD:Primary…
Primary objective:• To evaluate the safety and tolerability of single intravenous (i.v.) doses of XAB05 in healthy subjects.Secondary objective:• To characterize the plasma pharmacokinetic (PK) profile of single i.v. doses of XAB05 in healthy…
Primary objective:* To evaluate the safety of BYON5667 eye drops.Secondary objective:* To evaluate the tolerability of BYON5667 eye drops.
* to evaluate the safety and tolerability of Lu AF90103 following single ascending intravenous (i.v.) doses* to investigate the pharmacokinetics (PK) of Lu AF90103 (prodrug) and Lu AF88361 (drug) in plasma and cerebrospinal fluid (CSF) following…
Primary objective: - To evaluate the systemic absorption and pharmacokinetics of topically applied NT-077 Secondary objectives: - To evaluate the safety and tolerability of topically applied NT-077- To evaluate the pharmacodynamic effect on sweat…