Clinical trials: sponsored by Jazz Pharmaceuticals
Healthy Participants
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JZP269 in Healthy Male and Female Participants
This study will characterize the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) of JZP269 in healthy participants.
- Trial name
- NCT07813663
- Testing
- JZP269
- Where
- 2 sites in United States
- Volunteers
- 212 people, healthy volunteers welcome
- Sponsor
- Jazz Pharmaceuticals
Healthy Participants
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of JZP047 in Healthy Participants
This is a Phase 1, double-blind, sponsor-unblinded, randomized, placebo-controlled study designed to characterize the safety, tolerability, and PK of JZP047 in healthy participants following single-ascending doses of study…
- Trial name
- NCT07377539
- Testing
- JZP047
- Where
- United States
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- Jazz Pharmaceuticals
Clinical High Risk for Psychosis (CHR), Clinical High Risk for Psychosis
Stratification and Treatment in Early Psychosis Study - PROMOTE
The purpose of this trial is: To investigate whether cannabidiol (CBD), compared to placebo, can reduce the severity of attenuated psychotic symptoms in individuals at clinical high risk for psychosis.
- Conditions
- Clinical High Risk for Psychosis (CHR), Clinical High Risk for Psychosis, Clinical High Risk for Developing Psychosis
- Trial name
- STEP-PROMOTE (NCT07434973)
- Testing
- Cannabidiol (CBD)
- Where
- 19 sites in Austria, Canada and 8 more
- Volunteers
- 586 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Early Life Adversity, Trauma
Study of Cannabidiol and Neuroimaging on Stress
Dysregulation in stress responsivity is a growing psychiatry-transdiagnostic fundamental phenomenon, with limited therapeutic strategies.
- Conditions
- Early Life Adversity, Trauma, Stress
- Trial name
- SCANS (NCT07278505)
- Testing
- Cannabidiol
- Where
- United States
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Icahn School of Medicine at Mount Sinai
Covid19
Defibrotide for the Treatment of Severe COVID-19
The goal of this study is to evaluate the safety and feasibility of defibrotide in COVID-19 pneumonia.
- Trial name
- NCT04652115
- Testing
- Defibrotide
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Brigham and Women's Hospital
Fragile X Syndrome
Effect of CBD on the Brain
This proposal focuses on the therapeutic relevance of the endocannabinoid (eCB) system for the treatment of Fragile-X syndrome (FXS), the primary hereditary cause of autism spectrum disorder (ASD).
- Trial name
- NCT06261450
- Testing
- CBD Oral Solution (eCBD system Target)
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Université de Sherbrooke
Healthy Participants
A Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JZP441 in Healthy Participants
Treatments for narcolepsy and hypersomnolence disorders should have good oral bioavailability and brain penetration properties. JZP441 has demonstrated wake-promoting efficacy and anticataplectic activity in nonclinical studies…
- Trial name
- NCT05720494
- Testing
- JZP441
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Jazz Pharmaceuticals
Healthy Participants
A Study to Investigate The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JZP441 in Sleep-deprived Healthy Participants
This Phase 1, double-blind, randomized, placebo-controlled study will characterize the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ascending nighttime doses of JZP441 in sleep-deprived healthy…
- Trial name
- NCT05651152
- Testing
- JZP441
- Where
- 2 sites in United States
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- Jazz Pharmaceuticals
Obstructive Sleep Apnea
Delphi Consensus Excessive Daytime Sleepiness in OSA
The objective of this study is to generate expert consensus statements on the differential diagnosis, definition, and management of EDS in patients with OSA who are adequately treated with primary therapy.
- Trial name
- NCT05055271
- Where
- United Kingdom
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- King's College London
Study the Efficacy of Epidiolex for Typical Absence Seizures
Epidiolex in Typical Absence Seizures
This is a Pilot study, open-label study consisting of a screening period of up to 4 weeks, a 4-week dose-titration treatment period to dose of up to 20 mg/kg/day BID of CBD (Epidiolex), and a 30 day safety follow-up period…
- Trial name
- NCT04899050
- Testing
- Cannabidiol (Epidiolex)
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- University of South Florida
Evaluation of Abuse Potential of Sativex
Abuse Potential of Sativex
This crossover study with six treatment sessions is to evaluate the abuse potential of three doses of Sativex as compared to Marinol and placebo, in subjects with a history of recreational marijuana use.
- Trial name
- NCT01323569
- Testing
- Sativex, Marinol
- Where
- Canada
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Jazz Pharmaceuticals
Food Effect
Study to Assess Food Effect on Sativex Bioavailability
Study to assess effect of food on the bioavailability of a single dose of Sativex and to measure its' pharmacokinetics after a single and multiple doses.
- Trial name
- NCT01322464
- Testing
- Sativex
- Where
- United Kingdom
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Jazz Pharmaceuticals
Evaluation of Pharmacokinetics of Sativex in the Absence and Presence of a Known Inducer of CYP3A4, Evaluation of Pharmacokinetics of Sativex in the Absence and Presence of a Potent Inhibitor of CYP3A4
Study to Evaluate the Effect of Rifampicin, Ketoconazole, and Omeprazole on the Pharmacokinetics of Sativex
Study to assess the effect of rifampicin, ketoconazole and omeprazole on the pharmacokinetics of a single dose of Sativex and to evaluate the safety of Sativex when given in combination with these other drugs.
- Conditions
- Evaluation of Pharmacokinetics of Sativex in the Absence and Presence of a Known Inducer of CYP3A4, Evaluation of Pharmacokinetics of Sativex in the Absence and Presence of a Potent Inhibitor of CYP3A4, Evaluation of Pharmacokinetics of Sativex in the Absence and Presence of a CYP2C19 Inhibitor
- Trial name
- NCT01323465
- Testing
- Sativex and rifampicin, Sativex and ketoconazole, Sativex and omeprazole
- Where
- United Kingdom
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Jazz Pharmaceuticals
Effects of Sativex on ECG
Sativex Thorough QT/QTc Study
This study was to evaluate effects of Sativex on electrocardiogram (ECG) traces when administered at its therapeutic dose of 8 sprays per day and at multiples of the therapeutic dose (24 or 36 sprays per day), and to evaluate its…
- Trial name
- NCT01322139
- Where
- Canada
- Volunteers
- 258 people, healthy volunteers welcome
- Sponsor
- Jazz Pharmaceuticals
Hepatic Impairment
Assessment of the Single Dose Pharmacokinetics and Tolerability of Sativex in Patients With Impaired Hepatic Function and Healthy Patients
A Phase I open-label study to evaluate the pharmacokinetics (what the body does to a drug), safety and tolerability of a single dose of Sativex (containing 10.8 mg tetrahydrocannabinol [THC] and 10 mg cannabidiol [CBD]) in…
- Trial name
- NCT01887301
- Testing
- Sativex
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Jazz Pharmaceuticals
Healthy Subjects
An Study to Evaluate the Effects of Fluconazole on the Pharmacokinetics (PK) of Sativex® in Healthy Subjects With Cannabis Experience.
The study aims to evaluate the effect of fluconazole on the pharmacokinetic (PK) profile of a single oromucosal dose of Sativex® (i.e.
- Trial name
- NCT02325011
- Testing
- Sativex® (Treatment A), Sativex® and fluconazole concomitantly (Treatment B)
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Jazz Pharmaceuticals
Epilepsy
A Study of the Safety and Tolerability of GWP42006 in Healthy Subjects
The primary objective of this study is to evaluate the safety and tolerability of single ascending (increasing) and multiple doses of GWP42006 compared with placebo.
- Trial name
- NCT01918735
- Testing
- GWP42006
- Where
- United Kingdom
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Jazz Pharmaceuticals
Hepatic Impairment
Safety and Pharmacokinetics of CMX001 in Impaired Hepatic Function and Healthy Subjects
This is an open-label, non-randomized, multi-center, sequential group, safety, tolerance, and Pharmacokinetic study of a single dose of CMX001 administered at 2 mg/kg of ideal body weight rounded to the closest 20 mg in fasted…
- Trial name
- NCT05391724
- Testing
- CMX001
- Where
- 3 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Jazz Pharmaceuticals
Daytime Sleepiness
Community-Level Daytime Sleepiness: Social-Environmental Determinants, Consequences, and Impact of Sleep Apnea
The purpose of this study is to examine daytime sleepiness in a community context. This includes examining sleepiness in a large sample in terms of social/behavioral/environmental predictors and health-related outcomes, as well…
- Trial name
- NCT04176042
- Testing
- Track 1, Track 2
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- University of Arizona
Sleep, Sleep Disorder
Language of Sleepiness
Subjects will complete an electronic consent form and then fill out questionnaires on a tablet computer. The answers to the questions will be recorded to a secure electronic database, along with the results of a clinical…
- Conditions
- Sleep, Sleep Disorder, Sleepiness
- Trial name
- NCT04323254
- Where
- 2 sites in United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego