Conditions: Asthma Chronic Obstructive Pulmonary Disease (COPD)
Keywords: AZD7594 Bioavailability Healthy male subjects Safety Tolerability Pharmacokinetics Monodose inhaler Multiple-dose dry powder inhaler
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 30
Healthy volunteers: yes

Brief summary:
This is an open-label,partially randomized, four-period study in healthy male subjects to assess the bioavailability and pharmacokinetics of a single dose of AZD7594 when administered intravenously, orally and inhaled via two different dry powder inhalers (DPIs) and a pressurized meter-dose inhaler (pMDI)

Detailed description:
This study is an open-label, partially randomized, 4-period, 5-treatment study in healthy male subjects, performed at a single study center. All subjects will receive the 4 of the 5 treatments. The IV infusion will be fixed as the first treatment (Period 1), the Monodose inhaler will be fixed as the second treatment (Period 2) and the oral formulation will be fixed as the fourth treatment (Period 4). During Period 3, subjects are split into 2 equal cohorts, multiple-dose DPI and pMDI.

Arms:
arm 1: 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) arm 2: 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)

Interventions: intervention 1: AZD7594 Solution for infusion (150 μg intravenous formulation) intervention 2: AZD7594 Oral suspension (1200 μg oral formulation) intervention 3: AZD7594 Inhalation powder (400 μg) by DPI Device 1 (monodose inhaler) intervention 4: AZD7594 Inhalation powder (400 μg) by DPI device 2 (multiple-dose inhaler) intervention 5: AZD7594 Pressurized inhalation suspension (400 μg) by pMDI
Intervention descriptions: intervention 1: Solution for infusion 0.01 mg/ml; AZD7594 150 μg IV intervention 2: 0.1 - 10 mg/g oral solution; AZD7594 1200 μg oral intervention 3: Inhalation powder, hard capsules 400 μg Monodose inhaler; AZD7594 400 μg by dry powder inhaler (DPI) Device 1 (Monodose inhaler) intervention 4: Inhalation powder, multiple-dose dry powder inhaler (DPI) 400 μg; AZD7594 400 μg by DPI Device 2 (multiple-dose DPI) intervention 5: Inhalation suspension 200 μg; AZD7594 400 μg by pressurized metered-dose inhaler (pMDI); 2 puffs x 200 μg = 400 μg

Protocol document: