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Excretion balance, pharmacokinetics and metabolism of S44819 after single administration of [14C]-S44819 in young healthy male volunteers. A phase 1 monocentre open-label study.

The purpose of the study is to investigate the pharmacokinetics of S 44819. S 44819 is labeled with 14-Carbon (14C) and is thus radioactive (also called radiolabeled). In this way, S 44819 and its metabolites can be traced in blood, urine and feces…

Single-center, open-label, non-randomized study investigating the excretion balance, pharmacokinetics and metabolism of a single oral dose of [14C]-labeled RO5285119 in healthy male subjects

The purpose of the study is to investigate how quickly and to what extent the study medication is absorbed, distributed, metabolized (broken down) and eliminated from the body (this is called pharmacokinetics). The compound to be administered will…

Validation of the novel PET tracer [18F]PK209 in healthy volunteers: Dosimetry, test-retest, and specific binding to the NMDA receptor

The objective of this project is to assess the applicability of [18F]PK209 for in vivo imaging of the NMDA receptor.

An open-label, two-period, fixed sequence study to evaluate the effects of multiple oral doses of AFQ056 on the pharmacokinetics of a monophasic oral contraceptive in healthy female volunteers

* To examine how multiple oral doses of the test compound (an experimental medication) will be taken up by the body, metabolized and excreted by the body in combination with the oral contraception pill which consists of ethinyl-estradiol and…

An open label extension study to evaluate long term use of a Food for Special Medical Purposes (FSMP) in patients with mild Alzheimer*s disease
who completed the Souvenir II study

The purpose of this open label extension study is to gather further compliance and safety information on the longer-term (up to approximately 48 weeks) use of the study product. This will provide valuable information in addition to the findings of…

A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis (CFTY720D2316)

Primary: Safety and tolerability of fingolimod 0,5 mg in a broader population of MS patients.Explorerend: incidence of macular edema, bradyarrythmia, Patient-Reported Outcomes Indices for Multiple Sclerosis (PRIMuS) and Short Form Health Survey*12 (…

Excretion balance, pharmacokinetics and metabolism of S 47445 after single oral administration of 20mg [14C]-S 47445 in young healthy male volunteers.

- to assess the excretion balance of total radioactivity in urine and faeces after single oral dose of 20 mg 2.35 MBq (64 µCi) of [14C]-S 47445, - to determine the pharmacokinetics of the total radioactivity in whole blood, plasma and urine after…

Examining the feasibility of exercise-related outcome measures for children with spastic cerebral palsy, who are propelling a manual wheelchair.

To develop reliable and feasible aerobic and anaerobic exercise tests for children with spastic CP who use wheelchairs.

A phase 0 validation study in healthy male volunteers assessing the safety and tolerability of serial CSF sampling and to evaluate biomarkers related to Alzheimer*s disease in CSF and plasma

The objective of this study is:• To investigate the safety and tolerability of 30 h continuous CSF sampling in healthy male subjects• To evaluate subject experiences of continuous CSF sampling using a standardized questionnaire.• To gain experience…

Validation of novel PET tracer [11C]-GMOM: Assessment of dosimetry, biodistribution, and specific binding in healthy volunteers

The objective of this project is to assess the applicability of [11C]GMOM for in vivo imaging of the NMDA receptor.

A Single-Center, Open-Label, Parallel Study to Investigate the Effects of Multiple Doses of Ketoconazole on the Pharmacokinetics of a Single Oral Dose of RO4602522 in Healthy Male Subjects.

The purpose of the study is to find out if there is a possible influence of Ketoconazole on the effect of RO4602522 (this is called pharmacodynamics). it will be investigated whether and if so to what extent Ketoconazole influences how fast…

Pilot study to investigate the EMG acvtivity and energy expenditure during sitting and standing in children with cerebral palsy

To gain insight in the muscle activity and energy expenditure during sitting and standing in children with CP.

Single-Center, Open-label Study Investigating the Excretion Balance, Pharmacokinetics and Metabolism of a Single Oral Dose of [14C]-radio-labeled RO4602522 in Healthy Male Volunteers

Primary:* To explore the routes and rates of elimination of [14C]-labeled RO4602522.* To investigate the pharmacokinetics of total drug related material, RO4602522 and its metabolites as appropriate.Secondary:* To investigate metabolic profiles of…

A Phase 3, Open-Label, Baseline-controlled, Multicenter, Sequential Dose Titration Study to Assess the Long-Term Efficacy and Safety, and the Pharmacokinetics of Solifenacin Succinate Suspension in Patients from 5 to Less than 18 years of Age with Neurogenic Detrusor Overactivity (NDO)

To evaluate the efficacy, safety and PK of solifenacin succinate suspension after multiple dose administration.

A Multicentre, Open-Label, Long-Term, Safety and Tolerability Study of Retigabine Immediate Release (IR) in Adults with Partial-Onset Seizures (Extension of Study RGB113905: RTG113413).

Primary: Long-term safety and tolerability.Secondary: Long-term efficacy.

An Open-Label, Flexible-Dose Study of Retigabine Immediate Release (IR) as Adjunctive Therapy to Specified Monotherapy Antiepileptic Treatments in Adults with Partial-Onset Seizures (RGB113905)

Primary: To evaluate the efficacy of retigabine as adjunctive therapy to each of the following specified monotherapy AED treatments: carbamazepine/ oxcarbazepine, lamotrigine, levetiracetam or valproic acid in subjects with partial-onset seizures (…

A prospective explorative cross sectional clinical study to investigate the neurocognitive effects of human Immunodeficiency virus and the influence of highly active anti retroviral (HAART) therapy on CSF viral replication and biomarkers for neurodegeneration in HIV infected patients on chronic therapy with HAART

1 To investigate the influence of HAART on CSF viral load, development of HIV resistance, neurotransmitters and biomarkers for neurodegeneration2 To explore the neurocognitive effects of HIV infection and its treatment3 To investigate the…

The feasibility and energy expenditure of adults with stroke playing Wii-Sports

The aim of this study is to determine the feasibility and energy expenditure of adults with a stroke playing Wii-Sports.

The influence of oral contraceptives on lamotrigine clearance in patients on lamotrigine in combination with valproic acid, carbamazepine or oxcarbazepine as compared to patients on lamotrigine only.

In a previous prospective study(4), we investigated in detail the effect of OCs on LTG clearance. However, LTG is frequently used in combination therapy. This raises the question as to what extent and how co-medication with other anti-epileptic…

Pharmacokinetics of levetiracetam after rectal administration in healthy volunteers

Comparison of single-dose pharmacokinetics of levetiracetam after rectal versus oral administration at healthy volunteers.