Clinical trials: sponsored by H. Lundbeck A/S
Healthy
Eptinezumab in Healthy Japanese Subjects
The purpose of this study is to investigate how eptinezumab enters, moves through and exits the body. Safety and tolerability will also be investigated.
- Trial name
- NCT04336449
- Testing
- Eptinezumab
- Where
- Japan
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Parkinson Disease, Healthy
Study Investigating Effects of Foliglurax in Patients With Parkinson's Disease (PD) and Healthy Subjects
The purpose of this study is to investigate effects of foliglurax on brain wave patterns (electric signals) in healthy subjects and in patients with PD
- Trial name
- NCT04322227
- Testing
- Foliglurax 10 mg (treatment A), Foliglurax 30 mg (treatment B)
- Where
- France
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Healthy
Safety and Tolerability of Lu AF95245 in Healthy Young Men
The purpose of this study is to investigate the safety and tolerability of Lu AF95245 and what the body does to Lu AF95245 after swallowing single doses of the drug
- Trial name
- NCT04199585
- Testing
- Lu AF95245, Lu AF95245 14C radiolabelled spiked dosage
- Where
- Netherlands
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Schizophrenia
Positron Emission Tomography (PET) Study Investigating Dopamine and Serotonin Receptor Occupancy After Multiple Oral Dosing of Lu AF35700
The purpose of this PET study is to verify the binding of Lu AF35700 after multiple oral dosing at the dopamine and the serotonin receptors in male patients with schizophrenia.
- Trial name
- NCT02333487
- Testing
- Lu AF35700
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- H. Lundbeck A/S
Healthy
Effects of Repeated Doses of Foliglurax on Drug Metabolizing Enzymes in Healthy Subjects
The purpose of this study is to help determine which types of drugs that may interact with foliglurax
- Trial name
- NCT04275115
- Testing
- Drug Cocktail, Foliglurax, midazolam iv
- Where
- France
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Healthy
A Study Investigating Tablet Formulations of Lu AF11167 in Healthy Subjects
The purpose of this study is to investigate the extent to which Lu AF11167 enters the bloodstream following tablet intake and the influence of food on uptake in healthy men and women
- Trial name
- NCT04104503
- Testing
- Lu AF11167, [14C]-Lu AF11167, Lu AF11167 MR tablet prototype formulation selected from part A or 1 mg modified release tablet (reference formulation)
- Where
- United Kingdom
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Major Depressive Disorder
Study With Vortioxetine on Emotional Functioning in Patients With Depression
The study will evaluate effectiveness of flexible dose vortioxetine 10-20 mg/day on emotional functioning in patients with MDD with an inadequate response to SSRIs/SNRIs.
- Trial name
- COMPLETE (NCT03835715)
- Testing
- Vortioxetine
- Where
- 23 sites in France, Italy and 2 more
- Volunteers
- 150 people
- Sponsor
- H. Lundbeck A/S
Alzheimer Disease
Study With Lu AF20513 in Patients With Mild Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI) Due to AD
The purpose of this study is to study the effect of monthly dosing with a single dose of Lu AF20513, with and without booster vaccine, on antibody response.
- Trial name
- NCT03819699
- Testing
- Lu AF20513, booster vaccine
- Where
- 3 sites in Finland, Sweden
- Volunteers
- 3 people
- Sponsor
- H. Lundbeck A/S
Parkinson Disease
A Positron Emission Tomography (PET) Study to Examine the Brain Binding Properties of a Novel Radioactive Compound [11C]-PXT012253 in Healthy Subjects
This study evaluates the usefulness of a PET radioligand to estimate the binding on the mGlu4 receptor in the brain. mGlu4 has been proposed as a therapeutic target in Parkinson's disease.
- Trial name
- NCT03826134
- Testing
- [11C]PXT012253
- Where
- Sweden
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Treatment-resistant Schizophrenia
Efficacy of Lu AF35700 in Patients With Early-in-disease or Late-in-disease Treatment-resistant Schizophrenia
This study evaluates the efficacy of 10 mg/day Lu AF35700 on symptoms of schizophrenia in patients with early-in-disease (ED) or late-in-disease (LD) treatment-resistant schizophrenia (TRS)
- Trial name
- Anew (NCT03230864)
- Testing
- Lu AF35700, Risperidone, Olanzapine
- Where
- 41 sites in United States, Bulgaria and 3 more
- Volunteers
- 119 people
- Sponsor
- H. Lundbeck A/S
Alzheimer Disease
Study to Evaluate the Safety and Tolerability of a New Drug Named Lu AF20513 in Patients With Mild Alzheimer's Disease
The purpose of this study is to determine if multiple immunizations with Lu AF20513 is tolerable and safe in patients with mild Alzheimer's disease.
- Trial name
- NCT02388152
- Testing
- Lu AF20513, low dose, Lu AF20513, medium dose, Lu AF20513, high dose
- Where
- 5 sites in Austria, Finland and 1 more
- Volunteers
- 50 people
- Sponsor
- H. Lundbeck A/S
Schizophrenia
Effect of Lu AF35700 in Patients With Treatment-resistant Schizophrenia
To evaluate the efficacy of 10 and 20 mg/day of Lu AF35700 on schizophrenia symptoms in patients with treatment-resistant schizophrenia (TRS)
- Trial name
- DayBreak (NCT02717195)
- Testing
- Risperidone, Olanzapine, Lu AF35700
- Where
- 147 sites in United States, Bulgaria and 12 more
- Volunteers
- 1,098 people
- Sponsor
- H. Lundbeck A/S
Alzheimer's Disease
A Study to Evaluate the Long-term Safety and Tolerability of Lu AF20513 and the Antibody Response in Patients With Alzheimer's Disease (AD)
The purpose of this study is to evaluate the long-term safety, tolerability and antibody response of Lu AF20513 in patients with Alzheimer's disease who have completed the 16026A study.
- Trial name
- NCT03668405
- Testing
- Lu AF20513
- Where
- 4 sites in Finland, Sweden
- Volunteers
- 18 people
- Sponsor
- H. Lundbeck A/S
Healthy
What the Body Does to Foliglurax in Healthy Volunteers
This study evaluates how the body takes up and gets rid of foliglurax after swallowing a liquid dose.
- Trial name
- Foliglurax (NCT04002895)
- Testing
- Foliglurax
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Healthy
Study With Lu AF35700 in Healthy Men and Women in Fasting and Fed State
The purpose of this study is to investigate the extent to which Lu AF35700 enters the bloodstream following pill intake and the influence of food on the uptake in healthy men and women
- Trial name
- NCT03670082
- Testing
- Lu AF35700, Lu AF35700 iv
- Where
- United Kingdom
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Cytochrome P450 Interaction
Study Evaluating the Effect of Multiple Doses of Itraconazole on the Drug Lu AF35700 in Healthy Young Men and Women
This study will investigate the effect of multiple doses of the strong P450 enzyme inhibitor itraconazole on the pharmacokinetics of Lu AF35700 in healthy subjects.
- Trial name
- NCT03103646
- Testing
- Lu AF35700, Itraconazole (200 mg), Itraconazole (300 mg)
- Where
- 2 sites in United States, United Kingdom
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Renal Failure
Pharmacokinetics of Lu AF35700 in Subjects With Renal Impairment
This study will evaluate the pharmacokinetics of Lu AF35700 after a single dose tablet to subjects with renal impairment (kidney insufficiency) and compare that with healthy subjects
- Trial name
- NCT03241147
- Testing
- Lu AF35700
- Where
- Germany
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Healthy
Single Dose of Lu AF28996 to Healthy Young Men
This study evaluates how increasing doses of Lu AF28996 enters, moves through and exits the body when given by mouth to healthy young men.
- Trial name
- NCT03565094
- Testing
- Lu AF28996 solution, Lu AF28996 capsule
- Where
- Netherlands
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Schizophrenia, Schizoaffective Disorder
Study Investigating the Effect of Lu AF35700 on Cardiac Repolarization in Men and Women With Schizophrenia and Schizoaffective Disorder
The purpose of this study is to investigate the effect of Lu AF35700 on electrical activity in the heart as measured on an electrocardiogram (ECG) in patients with schizophrenia or schizoaffective disorder after 6 weeks of…
- Trial name
- NCT02901587
- Testing
- Lu AF35700 (10 mg/day), Lu AF35700 (30 mg/day), Quetiapine (Seroquel XR® 800 mg/day)
- Where
- United States
- Volunteers
- 119 people
- Sponsor
- H. Lundbeck A/S
Major Depressive Disorder
Vortioxetine Intravenous Infusion at Initiation of Oral Treatment With Vortioxetine in Patients With Depression
The purpose of this study is to evaluate the efficacy and safety of vortioxetine given as a single intravenous dose of 25 mg at initiation of an oral vortioxetine regimen of 10 mg/day for 7 days
- Trial name
- NCT03766867
- Testing
- Vortioxetine infusion 25 mg, Vortioxetine tablets 10 mg/day
- Where
- 13 sites in Bulgaria, Estonia and 1 more
- Volunteers
- 80 people
- Sponsor
- H. Lundbeck A/S