Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sativex and rifampicin · 1 trial · 3 indications
| Arm | Type | Description |
|---|---|---|
| Sequence 1A | EXPERIMENTAL | Sativex and rifampicin |
| Sequence 1B | EXPERIMENTAL | Sativex and rifampicin |
| Sequence 2C | EXPERIMENTAL | Sativex and ketoconazole |
| Sequence 2D | EXPERIMENTAL | Sativex and ketoconazole |
| Sequence 3E | EXPERIMENTAL | Sativex and omeprazole |
| Sequence 3F | EXPERIMENTAL | Sativex and omeprazole |
| Name | Type | Description |
|---|---|---|
| Sativex and rifampicin | DRUG | Single dose of 4 sprays Sativex on Day 1, Rifampicin 2 x 300 mg capsules on Days 2-10, Sativex dose of 4 sprays and rifampicin 2 x 300 mg capsules on Day 11. |
| Sativex and ketoconazole | DRUG | Single dose of 4 sprays Sativex on Day 1, ketoconazole 2 x 200 mg tablets on Days 2-5, Sativex x 4 sprays and ketoconazole 2 x 200mg on Day 6. |
| Sativex and omeprazole | DRUG | Single dose of 4 sprays of Sativex on Day 1 Omeprazole 2 x 20 mg on Days 2-6. Sativex x 4 sprays and omeprazole 2 x 20 mg on Day 9. |
Inclusion Criteria: * Healthy male subjects between 18 and 45 years of age (inclusive). * Subjects body mass index was between 18-30 kg/m2 (inclusive) as calculated by: Weight (kg)/height (m2). * No clinically significant abnormal findings on the physical examination, ECG, medical history, or clini...
Sativex is an investigational drug being studied for the treatment of spasticity in children aged 8 to 18 years with cerebral palsy. It has also been evaluated in healthy subjects for pharmacokinetic studies, including food effects and drug interactions, and for its abuse potential.
Sativex is being developed by Jazz Pharmaceuticals plc, a company traded on the NASDAQ under the ticker symbol JAZZ. The company is conducting clinical trials to evaluate the drug's safety, efficacy, and pharmacokinetics in various patient populations.
Sativex is in Phase 1 clinical development. The drug has completed Phase 1 trials evaluating its pharmacokinetics, including food effects and drug interactions, as well as a Phase 3 trial for spasticity in children with cerebral palsy. It remains investigational and is not yet approved.
Sativex has been studied in several completed clinical trials. These include NCT01322464, a Phase 1 food effect study; NCT01323465, a Phase 1 drug interaction study with rifampicin, ketoconazole, and omeprazole; NCT01898520, a Phase 3 study for spasticity in children with cerebral palsy; and NCT02325011, a Phase 1 study with fluconazole.
Sativex is a specific product name for a cannabis-based medicine. The drug is being studied for conditions such as cerebral palsy and spasticity. It is developed by Jazz Pharmaceuticals and is currently in clinical trials, though it has not been approved for these indications.