111 results
The study will be performed in 2 parts, Part 1 and Part 2). The purpose of the study is to investigate how quickly and to what extent Olesoxime is absorbed and eliminated from the body. In addition, it will be investigated how safe Olesoxime is and…
To analyze the difference in fT>MIC at the target site and infection rate for a single dose of 1 and 2g of cefazolin.
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…
The primary objective of the study is to evaluate a dose-response signal of IFX-1 in subjects with HS according to the HiSCR at Week 16. The secondary objectives of the study are:* To assess the efficacy of IFX-1 using additional outcome measures*…
The purpose of this study is to explore if the (f)MRI- and behavioral assessment are reproducible and suitable for drug studies performed at more than one medical center or clinic.
Part 1, 2 and 3;To assess the safety and tolerability of single and multiple ascending doses of RO7017773 in healthy participants.To investigate the PK of RO7017773 in plasma and urine.To investigate the PD effects of RO7017773 treatment on specific…
Primary- Phase 1: To determine the recommended dose (RD) of cabiralizumab in patients with pigmented villonodular synovitis (PVNS)/diffuse type tenosynovial giant cell tumor (dt-TGCT)- Phase 2: To estimate the objective response rate (ORR = CR+PR)…
Primary Efficacy Objectives:* To demonstrate the decrease in anti-fXa activity following andexanet treatment.* To evaluate the hemostatic efficacy following andexanet treatment.Secondary Efficacy Objective:* To assess the relationship between…
The hypothesis is that a switch from intravenous to oral antimicrobial therapy is non-inferior to standard intravenous therapy in patients with low-risk SAB. Therefore, the primary objective of the trial is to demonstrate, that oral switch therapy (…
To assess the safety and tolerability and to define the dose limiting toxicities (DLT) and maximum tolerated dose (MTD) of BMS-986158 as for subjects with selected advanced solid tumors.
The primary objective of the study is To evaluate the efficacy of BG00011 compared with placebo in subjects with IPF.The secondary objectives of the study are:* To evaluate the efficacy of BG00011 compared with placebo in subjects with IPF as…
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…
• 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
Evaluate the antitumor activity of nemvaleukin alfa (*nemvaleukin*, ALKS 4230) in combination with pembrolizumab as compared with chemotherapy in patients with platinum-resistant ovarian cancerSecondary Objectives:Evaluate the antitumor activity of…
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…
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…
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…
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…