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How sickening is sitting: experimental evidence

18-22 YEAR OLD MALES WIHT A NORMAL WEIGHTExamine the possible attenuating cardiometabolic health effects of (A) hourly, 10-min standing interruptions, when compared to a single bout of prolonged sitting, and (B) sitting on a stability ball, when…

Mood, serotonin and social interaction

This project aims to study how changes in serotonin alter interpersonal functioning in adults with or without a first degree family member diagnosed with MDD. The primary goal is to investigate the effect of experimentally lowered brain serotonin…

DIStal versus COnventional RADIAL access for coronary angiography and
intervention: a randomized multicenter trial

The objective of this study is to demonstrate the superiority of Distal Transradial Access (DTRA) to Conventional Transradial Access (CTRA) regarding forearm radial artery occlusion (RAO) using the 6Fr Glidesheath Slender (GSS).

A bridging trial to compare the pharmacokinetics of Glepaglutide (ZP1848) after a single subcutaneous administration by vial/syringe and by autoinjector in healthy subjects: a phase 1, randomized, open-label, three-way, reference-replicated crossover trial

- To compare the pharmacokinetics (PK) of glepaglutide after a single subcutaneous (SC) administration by vial/syringe and by autoinjector.- To evaluate the safety and tolerability of glepaglutide following SC dosing in healthy subjects.

A Multicenter, Randomized, Placebo-Controlled, Double-Blind Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAR443060 in Subjects with Amyotrophic Lateral Sclerosis (ALS)

Double-blinded part:The primary objectives of the study are as follows:• To investigate the safety and tolerability of 28 days of oral doses of SAR443060 in subjects with ALS.The secondary objectives of the study are as follows: • To characterize…

A single center, randomized study investigating the safety, tolerability, and pharmacokinetics of AZ-009 (Staccato apomorphine) in healthy volunteers and the safety, tolerability, pharmacokinetics, and pharmacodynamics of AZ-009 in subjects with established Parkinson*s Disease.

To examine the safety, tolerability, and pharmacokinetic profile of single ascending doses of AZ-009 compared to placebo (part B and C) or to Apo-Go (part A) in healthy volunteers being pretreated with domperidone and in patients with Parkinson…

An Open-Label, Randomized, Crossover Pilot Study to Evaluate the Pharmacokinetics and Relative Bioavailability of JZP-324 Formulations vs. Xyrem in Healthy Subjects

Part 1:The purpose of the study is to compare 5 different JZP-324 formulations to Xyrem. It will be investigated how quickly and to what extent JZP-324 is absorbed and eliminated from the body (this is called pharmacokinetics) when compared to Xyrem…

Biocomparison study of crushed elbasvir/grazoprevir compared to the whole tablet (CRUSADE-2)/Hep-NED005

Primary objective:To assess pharmacokinetic similarity of EBR/GZR as a crushed (test) Zepatier tablet compared to a whole (reference) tablet.Secondary objective:To assess Cmax similarity of EBR/GZR as a crushed (test) Zepatier tablet compared to a…

Randomized, double blind, placebo- and active comparator- controlled 3-way crossover study in healthy subjects to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ENX-201

To assess PK of MPhs and MP.

Effect of the SGLT-2 inhibitor dapagliflozine on impaired awareness of hypoglycemia in type 1 diabetes

Primary objective: to investigate the effect of treatment with the SGLT-2 inhibitor dapagliflozin on the awareness of and counterregulatory hormone responses to hypoglycemia in people with type 1 diabetes and impaired awareness of hypoglycemia.…

Adjustment of insulin Degludec to Reduce post-Exercise (nocturnal) hypoglycaeMia in people with diabetes - the ADREM study

To examine the effect of two different degludec dose adjustments on glucose profiles and the incidence of (nocturnal) hypoglycaemia after oxidative exercise in people with DM1 at elevated risk of hypoglycaemia.

An International, Multicenter, Open-label, Randomized, Phase 3 Study of BLU 285 vs Regorafenib in Patients with Locally Advanced Unresectable or Metastatic Gastrointestinal Stromal Tumor (GIST)

Primary Objective:* The primary objective is to demonstrate the efficacy of avapritinib based on progression-free survival (PFS) determined by central radiological assessment per modified Response Evaluation Criteria in Solid Tumors (mRECIST),…

A phase I, open-label, randomized, three-way cross-over study comparing bioavailability of two formulations and assessing the food effect on tablet formulation after PXL770 single oral dose in healthy subjects

The purpose of this study is compare a tablet formulation of PXL770 to the capsule formulation of PXL770. It will be investigated how quickly and to what extent PXL770 in each formulation is absorbed and eliminated from the body. To limit the…

A phase 1, double-blind placebo-controlled single and multiple ascending dose study of the safety, tolerability, pharmacokinetics, pharmacodynamics and food effects of IFM-2427 in healthy subjects

The purpose of this study is to investigate how safe the new compound IFM-2427 is and how well it is tolerated when it is administered to healthy volunteers. IFM-2427 has not been administered to humans before; it will be administered to healthy…

A trial to assess the injection site pain experience of excipient solutions relevant for subcutaneous injection

The primary objective is to assess, in healthy subjects with a body mass index (BMI) greater than or equal to 25.0 kg/m2, the injection site pain experience of 9 excipient solutions (Trial Products 4 to 12), intended to be used in future…

A Randomised Feasibility n-of-1 Trial of Weekly-Interval Red Cell Transfusion in myelodysplastic syndromes; Red blood cell transfusion schedule in myelodysplastic syndromes (REDDS): study 2

This protocol describes a two-part study to assess red blood cell (RBC) transfusion schedules in patients with transfusion-dependent myelodysplastic syndromes (MDS).The first part of the study is a pilot n-of-1 study to assess the feasibility of a…

Evaluating the safety, tolerability, and pharmacodynamic properties of IW-6463 in healthy elderly subjects.

Primary* To evaluate the effect of IW-6463 on cerebral blood flow (CBF) in healthy elderly participants* To assess the safety and tolerability of IW-6463 vs placebo when administered to healthy elderly participants for up to 15 daysExploratory* To…

A Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Profile of AZ-009 in Subjects with Established Parkinson*s Disease

Objectives of part A:- evaluate the safety, tolerability and pharmacokinetics of 2, 3 or 4 mg AZ-009 after 5 days of dosing in people with Parkinson's disease- evaluate the safety, tolerability and pharmacokinetics of 2, 3 or 4 mg AZ-009 after…

An exploratory single-centre cross-over study in healthy subjects to investigate the effects of sleep deprivation on driving, EEG, and PainCart.

Part A• To assess the effect of sleep deprivation on next morning driving (both on road and in simulated driving) and subjective self-reported driving performance tests;• To assess the effect of sleep deprivation on CNS functioning using the…

A randomized cross-over trial in the effect of automated oxygen control devices on the distribution of oxygen saturation in preterm infants

To compare the effect of two automated oxygen controllers (Oxygenie and CLiO2) on time spent within oxygen target range in preterm infants.