Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD2516 · 5 trials · 4 indications
Total number of reflux episodes 0 to 3 hours post meal
| Arm | Type | Description |
|---|---|---|
| First 5 mg, then placebo, then 16 mg, then 40 mg | EXPERIMENTAL | period 1: AZD2516 5 mg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD2516 16 mg, period 6: washout, period 7: AZD2516 40 mg. |
| First 40 mg, then 16 mg, then placebo, then 5 mg | EXPERIMENTAL | period 1: AZD2516 40 mg, period 2: washout, period 3: AZD2516 16 mg, period 4: washout, period 5: placebo, period 6: washout, period 7: AZD2516 5 mg. |
| First 16 mg, then 5 mg, then 40 mg, then placebo | EXPERIMENTAL | period 1: AZD2516 16 mg, period 2: washout, period 3: AZD2516 5 mg, period 4: washout, period 5: AZD2516 40 mg, period 6: washout, period 7: placebo. |
| First placebo, then 40 mg, then 5 mg, then 16 mg | EXPERIMENTAL | period 1: placebo, period 2: washout, period 3: AZD2516 40 mg, period 4: washout, period 5: AZD2516 5 mg, period 6: washout, period 7: AZD2516 16 mg |
| 1 | EXPERIMENTAL | AZD2516 (dose escalating) |
| 2 | PLACEBO_COMPARATOR | Placebo |
| AZD2516 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| AZD2516, 5 mg | DRUG | Capsule, oral |
| AZD2516, 16 mg | DRUG | Capsule, oral |
| AZD2516, 40 mg | DRUG | Capsule, oral |
| Placebo | DRUG | Capsule, oral |
| AZD2516 | DRUG | Oral, single, daily, 11 days |
Inclusion Criteria: * Provision of signed informed consent * Healthy male subjects * Age 18-45 years, inclusive Exclusion Criteria: * Clinically significant illness within the 2 weeks prior to the first dose of study drug * History of clinically significant cardiovascular, respiratory, renal, hep...
AZD2516 is an investigational small molecule being developed by AstraZeneca for reflux. It has been studied in healthy volunteers to assess its safety, tolerability, and pharmacokinetics, but it is not approved and remains in clinical development.
AZD2516 targets the metabotropic glutamate receptor 5 (mGluR5). A positron emission tomography (PET) study was conducted to determine central mGluR5 receptor occupancy of AZD2516 in healthy volunteers.
AZD2516 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN.
AZD2516 is in Phase 1 clinical development. All completed trials for AZD2516 are Phase 1 studies, and the drug is not yet approved by regulatory authorities.
AZD2516 has been studied in several completed Phase 1 trials, including NCT00754715, NCT00892944, NCT00972049, and NCT01148095. These trials assessed safety, tolerability, pharmacokinetics, and mGluR5 receptor occupancy in healthy volunteers across Sweden, Japan, and the United Kingdom.
AZD2516 is the sole name provided for this investigational compound. No alternative names have been associated with it in the clinical trial records.