Clinical trials: sponsored by Vanda Pharmaceuticals
Bipolar I Disorder, Schizophrenia
Evaluating a New Iloperidone Titration Scheme in Bipolar I Disorder or Schizophrenia
This is a single-center open-label study to be conducted in the United States in subjects with bipolar I disorder or schizophrenia.
- Trial name
- NCT04127058
- Testing
- Iloperidone
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Vanda Pharmaceuticals
Jet Lag Disorder
An Observational Study to Investigate the Effects of Rapid Transmeridian Travel
Observational study to investigate circadian rhythm patterns
- Trial name
- NCT02560103
- Testing
- Transmeridian travel across multiple time zones
- Where
- 2 sites in United States
- Volunteers
- 119 people, healthy volunteers welcome
- Sponsor
- Vanda Pharmaceuticals
Non-24-Hour-Sleep-Wake Disorder
Open Label Study to Assess the Absolute Bioavailability of Tasimelteon (HETLIOZ™)
Hetlioz™ (tasimelteon) is used in the treatment of Non-24-Hour-Sleep-Wake Disorder (Non-24). Non-24 is very common in people who are totally blind because light can not reset their body clock.
- Trial name
- NCT02130999
- Testing
- tasimelteon 20 mg capsule, tasimelteon 2 mg I.V.
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Vanda Pharmaceuticals
Safety and Tolerability of Iloperidone
Tolerability and Pharmacokinetics of Iloperidone in Adolescent Patients
Tolerability, undertstanding of the action of the drug in the body, and understanding the effect of the drug in adolescent patients needing treatment with an antipsychotic medication
- Trial name
- NCT01495169
- Testing
- iloperidone (oral tablet)
- Where
- 10 sites in United States
- Volunteers
- 33 people
- Sponsor
- Vanda Pharmaceuticals
Healthy Volunteers
Study to Assess the Effect of Multiple Doses of Tradipitant on CYP3A4 Using Midazolam as a Substrate in Healthy Subjects
This study is designed to evaluate the potential effect of administration of tradipitant on CYP3A4 using midazolam pharmacokinetics as markers. The study will also further characterize the pharmacokinetics of tradipitant.
- Trial name
- NCT02621385
- Testing
- tradipitant, Midazolam
- Where
- Switzerland
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Vanda Pharmaceuticals
Smith Magenis Syndrome
Observational Study to Investigate the Melatonin and Cortisol Circadian Rhythms of Individuals With Smith-Magenis Syndrome (SMS)
The purpose of this study is to characterize the circadian rhythm disruption experienced by patients as determined by plasma melatonin, cortisol, and other circadian analytes
- Trial name
- NCT02180451
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Vanda Pharmaceuticals
Major Depressive Disorder
Melatonin Agonist Effects of Tasimelteon Versus Placebo in Patients With Major Depressive Disorder
The purpose of this study is to evaluate the safety and efficacy of an 8-week double-masked treatment of tasimelteon or placebo in male and female subjects with Major Depressive Disorder.
- Trial name
- MAGELLAN (NCT01428661)
- Testing
- tasimelteon
- Where
- 40 sites in United States
- Volunteers
- 507 people
- Sponsor
- Vanda Pharmaceuticals
Pruritus
Study of Itch Control by VLY-686 in Healthy Volunteers After Intradermal Injections of Substance P
The purpose of this study is to test whether VLY-686 can prevent or reduce the itch and dermatological reaction observed after healthy volunteers are injected with Substance P in comparison with placebo.
- Trial name
- NCT01919944
- Testing
- VLY-686
- Where
- Switzerland
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Vanda Pharmaceuticals
Non-24-Hour Sleep-Wake Disorder
Tasimelteon for the Treatment of Non-24-hour Sleep-Wake Disorder (N24HSWD) in Blind Individuals With no Light Perception
The purpose of this study is to evaluate the safety of tasimelteon in male and female patients who suffer from Non-24-Hour Sleep-Wake Disorder.
- Trial name
- NCT01429116
- Testing
- tasimelteon
- Where
- 22 sites in United States
- Volunteers
- 200 people
- Sponsor
- Vanda Pharmaceuticals
Non-24-Hour Sleep-Wake Disorder
Efficacy and Safety of Tasimelteon Compared With Placebo in Totally Blind Subjects With Non-24-Hour Sleep-Wake Disorder
The purpose of this study is to evaluate the efficacy and safety of a six month double-mask treatment of tasimelteon or placebo in male and female subjects with Non-24-Hour Sleep-Wake Disorder
- Trial name
- NCT01163032
- Testing
- tasimelteon
- Where
- 28 sites in United States, Germany
- Volunteers
- 136 people
- Sponsor
- Vanda Pharmaceuticals
Primary Insomnia
VEC-162 Study in Adult Patients With Primary Insomnia
The purpose of this study is to evaluate the efficacy and safety of a 5 week double-blind treatment period of VEC-162 as compared to placebo in male and female patients with primary insomnia.
- Trial name
- NCT00548340
- Testing
- VEC-162 20 mg, VEC-162 50 mg
- Where
- 35 sites in United States
- Volunteers
- 322 people
- Sponsor
- Vanda Pharmaceuticals
Insomnia
VEC-162 Study in Healthy Adult Volunteers in a Model of Insomnia
The purpose of this study is to determine the safety and efficacy of VEC-162 compared to placebo to improve sleep parameters in a model of insomnia.
- Trial name
- NCT00291187
- Testing
- 20 mg VEC-162, 50 mg VEC-162, 100 mg VEC-162
- Where
- 19 sites in United States
- Volunteers
- 411 people, healthy volunteers welcome
- Sponsor
- Vanda Pharmaceuticals
Non-24-Hour Sleep-Wake Disorder
Withdrawal Study to Demonstrate the Maintenance Effect in the Treatment of Non-24-Hour Sleep-Wake Disorder
The purpose of this study is to evaluate the maintenance effect and safety of 20 mg tasimelteon versus placebo in subjects suffering from Non-24-Hour Sleep-Wake Disorder.
- Trial name
- NCT01430754
- Testing
- tasimelteon
- Where
- 22 sites in United States
- Volunteers
- 20 people
- Sponsor
- Vanda Pharmaceuticals
Circadian Rhythm Sleep Disorders
Safety and Efficacy of VEC-162 on Circadian Rhythm in Healthy Adult Volunteers
The purpose of this study is to assess the safety and efficacy of VEC-162 compared to matching placebo on circadian phase shift and sleep parameters.
- Trial name
- NCT00490945
- Testing
- VEC-162
- Where
- 2 sites in United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Vanda Pharmaceuticals
Pharmacodyamics and Pharmacokinetics of Tasimelteon Alone and in Combination With Ethanol
Evaluation of the Pharmacodynamic and Pharmacokinetic Interactions of Tasimelteon and Ethanol
The purpose of this research study is to understand if there is any difference in the effects of tasimelteon when it is taken alone or in combination with alcohol.
- Trial name
- NCT01578057
- Testing
- tasimelteon, Ethanol
- Where
- Canada
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Vanda Pharmaceuticals
Renal Impairment
Pharmacokinetics of Tasimelteon in Subjects With Renal Impairment and Matched Control Subjects With Relatively Normal Renal Function
The purpose of this research study is to understand whether there is any difference in the amount of tasimelteon (including its breakdown products) in the blood of individuals with severe renal impairment compared to individuals…
- Trial name
- NCT01526746
- Testing
- Tasimelteon
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Vanda Pharmaceuticals
Healthy Volunteers
Effects of Smoking, Age and Body Size on Pharmacokinetics, Safety and Tolerability on Tasimelteon in Healthy Subjects
The purpose of this research study is to understand whether there is any difference in the amount of tasimelteon in the blood in smokers versus non-smokers.
- Trial name
- NCT01477619
- Testing
- Tasimelteon
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Vanda Pharmaceuticals
Healthy
Pharmacokinetics of Tasimelteon Alone and in Combination With a CYP3A4 Inhibitor, Ketoconazole, or a CYP3A4 Inducer, Rifampin.
The purpose of this research study is to understand whether there is any difference in the amount of tasimelteon (including its breakdown product) in the blood when taken alone and in combination with either rifampin or…
- Trial name
- NCT01637636
- Testing
- tasimelteon, Rifampin, Ketoconazole
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Vanda Pharmaceuticals
Healthy Volunteers
A Study to Assess the Effect Tasimelteon on the Cytochrome P450 3A4 and 2C8 Enzymes in Healthy Subjects
The purpose of this research study is to understand whether there is any difference in the amount of midazolam (including its breakdown product) in the blood when midazolam is given with tasimelteon, and whether there is any…
- Trial name
- NCT01402076
- Testing
- Tasimelteon, Rosiglitazone, Midazolam
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Vanda Pharmaceuticals
Healthy Volunteers
Pharmacokinetics of Tasimelteon Alone and in Combination With CYP1A2 Inhibitor, Fluvoxamine
The purpose of this research study is to evaluate whether administration of a CYP1A2 inhibitor affects the single-dose pharmacokinetics of tasimelteon and its metabolites.
- Trial name
- NCT01540500
- Testing
- Tasimelteon, Fluvoxamine
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Vanda Pharmaceuticals