View clinical trials related to Healthy Volunteers.
Filter by:Gastroesophageal reflux disease (GERD) is a very common condition affecting up to 30% of adults. To date, therapy consists of powerful acid suppression with proton pump inhibitors (PPI). Nevertheless, only 60-70% of GERD patients report complete symptom relief with this therapy. As the mechanisms underlying symptom perception in PPI resistant patients are not fully understood, there is currently no adequate therapy available. It is becoming increasingly clear that reflux, especially in the postprandial period, occurs from a reservoir of acid floating on top of the meal: the so-called "acid pocket". In this study, we aim to investigate further the acid pocket by determining its exact position and chemical contents between healthy volunteers, GERD patient who respond well and bad to PPI therapy and GERD patients with barrett's esophagus.
The purpose of this study is to assess the influence of simultaneous CYP3A4 and p-glycoprotein inhibition on lenvatinib pharmacokinetics following a single oral dose of 5 mg lenvatinib.
This two-part study will assess the safety and tolerability of single ascending oral doses of RO6806127 in a group of healthy male participants and investigate the effect of high fat and high caloric food on the relative bioavailability of a single oral dose of RO6806127 in a separate group of healthy male participants. The relationship between drug exposure and tolerability will be explored.
The purpose of this study is to evaluate a novel PET tracer ([11C]AS2471907), and to use [11C]AS2471907 to assess the level and time-course of enzyme occupancy in the human brain prior to and following single oral dose administration of ASP3662.
This study will compare the pharmacokinetic performance of film-coated tablet and granule formulations of RG1662 under fed and fasted conditions in healthy volunteers. A randomized, four-period, four-treatment crossover design is used. In each period, each volunteer will receive a single oral dose of the tablet or granule formulation either with or without food.
Midazolam is a rapid-acting benzodiazepine, with a short half-life (approximately 1.9 hours) and is primarily metabolised by CYP3A. Omeprazole is a selective proton pump inhibitor substrate used to reduce gastric acid secretion. Omeprazole is primarily metabolised by CYP2C19. Midazolam and omeprazole are both used as probe drugs in clinical pharmacology studies to evaluate clinical CYP3A and CYP2C19 drug interactions, respectively. Furthermore the EMA and the FDA guidance on drug interactions recommend the use of these drugs for such evaluations. The aim of this study is to assess the effect of PQ912 on the PK of midazolam and omeprazole. In vitro studies have demonstrated that PQ912 inhibits several CYP enzymes, including CYP3A4 and CYP2C19 and at the expected exposure levels in patients, has the potential to inhibit these enzymes in-vivo. This study is therefore planned to investigate the potential changes in the PK of midazolam and omeprazole due to the effect of PQ912 at steady-state. In clinical practice it is likely that co-administration of PQ912 with other drugs that are metabolised via the CYP3A and/or CYP2C19 enzymes will occur. This study will provide important information for the requirement of dose adjustments or contraindications in these circumstances.
The purpose of this study is to evaluate the pharmacokinetic and safety profile of the sustained-release formulation of deferiprone under both fasting and fed conditions, and evaluate the relative bioavailability of this sustained-release formulation when compared to immediate-release formulation of deferiprone under fasting conditions.
The primary objective of the study is to evaluate the pharmacokinetic characteristics and demonstrate bioequivalence of a reconstituted new lyophilized formulation of caplacizumab for subcutaneous (s.c.) injection as compared to an equal nominal s.c. dose of the reference liquid formulation of caplacizumab. The secondary objective of the study is to compare the safety and tolerability, and the pharmacodynamic parameters of the new formulation with those of the reference formulation.
All subjects in this study will be given tafamidis. After swallowing a single pill of tafamidis, measurements including blood samples will be compared to see if tafamidis made in different ways is about the same. After approximately 28 days subjects will be given another pill of tafamidis and the study measurements will be repeated.
The aim of the study is to confirm that the new generation state of the art breath analyzer gives equivalent results to the previous model of the Exalenz breath analyzer.