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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02780713 | A Study to Assess the Pharmacokinetics and Safety of Different Forms and Formulations of AZD9496 in Healthy Subjects | PHASE1 | COMPLETED | 14 | — | — | Jun 2, 2016 | Sep 20, 2016 | Aug 25, 2021 | 1 | United States |
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
| 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 |
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...