Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD7594 for infusion · 1 trial · 2 indications
For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594
| Arm | Type | Description |
|---|---|---|
| Treatment sequence 1 | EXPERIMENTAL | Treatment Period 1:AZD7594 Solution for infusion (150 μg intravenous formulation) Treatment Period 2:AZD7594 Inhalation powder (400 μg) by dry powder inhaler (DPI) Device 1 (monodose inhaler) Treatment Period 3:AZD7594 Inhalation powder (400 μg) by DPI device 2 (multiple-dose inhaler) Treatment Period 4:AZD7594 Oral suspension (1200 μg oral formulation) |
| Treatment sequence 2 | EXPERIMENTAL | Treatment Period 1:AZD7594 Solution for infusion (150 μg intravenous formulation) Treatment Period 2:AZD7594 Inhalation powder (400 μg) by dry powder inhaler (DPI) Device 1 (monodose inhaler) Treatment Period 3:AZD7594 Pressurized inhalation suspension (400 μg) by pressurized metered-dose inhaler (pMDI) Treatment Period 4:AZD7594 Oral suspension (1200 μg oral formulation) |
| Name | Type | Description |
|---|---|---|
| AZD7594 Solution for infusion (150 μg intravenous formulation) | DRUG | Solution for infusion 0.01 mg/ml; AZD7594 150 μg IV |
| AZD7594 Oral suspension (1200 μg oral formulation) | DRUG | 0.1 - 10 mg/g oral solution; AZD7594 1200 μg oral |
| AZD7594 Inhalation powder (400 μg) by DPI Device 1 (monodose inhaler) | DRUG | Inhalation powder, hard capsules 400 μg Monodose inhaler; AZD7594 400 μg by dry powder inhaler (DPI) Device 1 (Monodose inhaler) |
| AZD7594 Inhalation powder (400 μg) by DPI device 2 (multiple-dose inhaler) | DRUG | Inhalation powder, multiple-dose dry powder inhaler (DPI) 400 μg; AZD7594 400 μg by DPI Device 2 (multiple-dose DPI) |
| AZD7594 Pressurized inhalation suspension (400 μg) by pMDI | DRUG | Inhalation suspension 200 μg; AZD7594 400 μg by pressurized metered-dose inhaler (pMDI); 2 puffs x 200 μg = 400 μg |
Inclusion Criteria: 1. Provision of signed and dated, written informed consent prior to any study specific procedures. 2. Healthy male subjects aged 18 - 45 years with suitable veins for cannulation or repeated venipuncture. 3. Have a body mass index (BMI) between 18 and 30 kg/m2, inclusive, and we...