Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD5213 · 5 trials · 6 indications
Brief pain Index - diabetic painful neuropathy (BPI-DPN) - average daily pain, Item 5 (final 2 day diary + in clinic assessment at end of 3 week treatment period)
Total Tic Severity Score on the the Yale Global Tic Severity Scale - Part 2 only (lower is better), range 0 - 50
Pharmacokinetics Part 1 only: Maximum plasma Concentration (ng/ml) Single dose Day 1 AZD5213 0.5 mg
Pharmacokinetics Part 1 only: Time to maximum plasma concentration (hr)Single dose Day 1 AZD5213 0.5 mg
Pharmacokinetics Part 1 only: Single dose Day 1 AZD5213 0.5 mg Area Under the Concentration time curve (AUC) 0 to infinity (h\*ng/ml)
Total sleep time (TST) is defined as the total time in minutes, that subjects were determined to be in a sleep state by polysomnography (PSG) measurement.
Each healthy volunteer in the main panel will complete 3 PET measurements using radioligand; one at baseline and 2 after treatment with AZD5213.
| Arm | Type | Description |
|---|---|---|
| placebo capsules | PLACEBO_COMPARATOR | Capsules to match pregabalin and AZD5213 |
| AZD5213 + pregabalin | EXPERIMENTAL | AZD5213 in combination with pregabalin |
| pregabalin | ACTIVE_COMPARATOR | pregabalin capsules |
| Placebo | PLACEBO_COMPARATOR | - |
| low dose AZD5213 | EXPERIMENTAL | - |
| high dose AZD5213 | EXPERIMENTAL | - |
| AZD5213 doseA | EXPERIMENTAL | AZD5213 doseA daily |
| AZD5213 doseB | EXPERIMENTAL | AZD 5213 doseB daily |
| AZD5213 doseC | EXPERIMENTAL | AZD5213 doseC daily |
| Pilot panel | EXPERIMENTAL | \[11C\]AZ12807110 distribution and kinetics |
| Main panel | EXPERIMENTAL | Histamine receptor occupancy reached by AZD5213 |
| 1 | EXPERIMENTAL | dose escalating |
| 2 | PLACEBO_COMPARATOR | placebo |
| Name | Type | Description |
|---|---|---|
| AZD5213 + pregabalin | DRUG | Double blind Investigational drug AZD5213 (capsules) given in combination with pregabalin (capsules) |
| Placebo | DRUG | Double blind placebo capsules to match AZD5213 and pregabalin |
| pregabalin capsules | DRUG | Double blind pregabalin capsules to match AZD5213 and placebo |
| AZD5213 and placebo | DRUG | low dose AZD5213 capsules; high dose AZD5213 capsules; placebo capsules |
| AZD5213 | DRUG | AZD5213 doseA daily |
| [11C]AZ12807110 | OTHER | Radioligand |
Inclusion Criteria: 1\. Male or female, age 18 to 75 years, inclusive, at Screen. 2. Subjects must provide informed consent in accordance with local regulations before the conduct of any study-related procedures. The informed consent should reflect the protocol stipulations concerning the use of co...
AZD5213 is an investigational small molecule developed by AstraZeneca PLC (ticker AZN). It has been studied in clinical trials for painful diabetic neuropathy, Tourette syndrome, and mild cognitive impairment, including mild Alzheimer's disease. It is not an approved medicine and remains in clinical development.
AZD5213 has been studied for painful diabetic neuropathy, Tourette syndrome, and mild cognitive impairment, including mild Alzheimer's disease. One trial also evaluated its brain distribution and receptor occupancy. It is investigational and has not been approved for any indication.
AZD5213 is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca sponsored the clinical trials of AZD5213, including studies in painful diabetic neuropathy, Tourette syndrome, and mild cognitive impairment.
AZD5213 is in clinical development. A Phase 1 brain distribution and receptor occupancy study has been completed, and Phase 2 studies in painful diabetic neuropathy, Tourette syndrome, and mild cognitive impairment have also been completed. It is investigational and not approved.
Completed trials include NCT01928381 in painful diabetic neuropathy with pregabalin, NCT01904773 in adolescents with Tourette syndrome, NCT01548287 in mild cognitive impairment and mild Alzheimer's disease, and NCT01194986, a Phase 1 brain distribution and receptor occupancy study.