Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01323465 | Study to Evaluate the Effect of Rifampicin, Ketoconazole, and Omeprazole on the Pharmacokinetics of Sativex | PHASE1 | COMPLETED | 36 | — | — | Feb 1, 2008 | Mar 1, 2008 | Apr 10, 2023 | 1 | United Kingdom |
| 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...