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Also known as AZD9496 (Reference)
AZD9496 · 2 trials · 2 indications
To evaluate maximum observed plasma concentration (Cmax) for AZD9496 and its metabolites M3 and M5 following administration of different AZD9496 formulations and compare with a reference formulation.
To evaluate the area under the plasma concentration-curve from time zero to time of last quantifiable concentration (AUC (0-t) of AZD9496 and its metabolites M3 and M5 following administration of different AZD9496 formulations and compare with a reference formulation
To evaluate maximum plasma concentration (Cmax) of capsule variants by comparing with reference AZD9496
To evaluate area under curve from time zero to time with last observation (AUC0-t) of variants by comparing with reference AZD9496
To evaluate area under the curve from time zero to time infinity (AUC 0-infinity) of variants by comparing with reference AZD9496
To evaluate area under the curve from time zero to infinity (AUC 0-infinity) for AZD9496 and its metabolites
Safety and tolerability in terms of adverse events, serious adverse events (including death) and safety measures: ECG, physical examination, vital signs and laboratory variables. Definition of maximum tolerated dose (MTD) or maximum feasible dose (MFD) by measuring the number of evaluable patients with dose-limiting toxicities.Time frame DLT period 28 days
| Arm | Type | Description |
|---|---|---|
| AZD9496 | EXPERIMENTAL | This is a fixed sequence study with 5-sequential treatment periods in healthy volunteers. Each volunteer will receive 5 single doses of AZD9496 in different forms, formulations and doses. 1. Treatment period 1 will assess AZD9496 Variant A: 100mg. 2. Treatment period 2 will assess AZD9496 Reference: 100mg. 3. Treatment period 3 will assess one of AZD9496 Variants, B, C or D: 100mg. 4. Treatment period 4 will assess one of AZD9496 Variants, B, C or D: 100mg. 5. Treatment period 5 will assess one of AZD9496 Variants A, B, C or D: \*300mg. \*Based on a review of PK and safety results from Treatment Periods 1, 3 and 4, a lower dose of 200 mg may be administered in Treatment Period 5 |
| Name | Type | Description |
|---|---|---|
| AZD9496 (Reference) | DRUG | AZD9496 (Reference) |
| AZD9496 Variant A | DRUG | AZD9496 Variant A. |
| AZD9496 Variant B | DRUG | AZD9496 Variant B |
| AZD9496 Variant C | DRUG | AZD9496 Variant C |
| AZD9496 Variant D | DRUG | AZD9496 Variant D |
| AZD9496 | DRUG | AZD9496 |
Inclusion Criteria: 1. Provision of signed and dated, written informed consent prior to any study specific procedures. 2. Healthy male and/or female subjects aged 18 to 65 years with suitable veins for cannulation or repeated venipuncture. 3. Females must have a negative pregnancy test at screening...
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AZD9496 is an investigational small molecule developed for breast cancer, specifically ER+ HER2- advanced breast cancer. It has been studied in Phase 1 clinical trials in patients with this form of advanced breast cancer. It is not an approved therapy and remains in clinical development.
AZD9496 is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca sponsored the Phase 1 clinical studies of the compound in advanced breast cancer and in healthy volunteers.
AZD9496 is in Phase 1 clinical development. Two Phase 1 trials have been completed, including a first-in-patient dose escalation study in ER+ HER2- advanced breast cancer and a pharmacokinetics and safety study in healthy subjects. No later-phase trials have been reported.
AZD9496 has been evaluated in two completed Phase 1 trials. NCT02248090 was a first-in-patient ascending dose study in ER+ HER2- advanced breast cancer across the United States, South Korea, and the United Kingdom, enrolling 45 patients. NCT02780713 assessed pharmacokinetics and safety of different forms and formulations in 14 healthy subjects in the United States.
Yes, AZD9496 (Reference) is an alternative name for AZD9496. Both names refer to the same investigational small molecule developed by AstraZeneca for ER+ HER2- advanced breast cancer, so searches using either name point to the same compound.