Study identifier:D1950C00008
ClinicalTrials.gov identifier:N/A
EudraCT identifier:2009-017702-36
CTIS identifier:N/A
A Phase I study to investigate the relative bioavailability of modified-release formulations of AZD1446 compared to an immediate-release capsule under fed and fasting conditions following single and repeated dose administration to young and elderly healthy volunteers
Healthy
Phase 1
Yes
AZD1446, Placebo
All
62
Interventional
18 Years - 80 Years
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Basic Science
Verified 01 Jul 2014 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
-
Part 1: The purpose of this study is to determine the pharmacokinetic profile of 4 different Extended/modified-release formulations and one immediate release formulation of AZD1446. In addition the food effect on AZD1446 pharmacokinetics will be investigated. Part 2: To asses the safety and tolerability of the selected formulation(s) from part 1 in elderly healthy volunteers.
Location
Location
Uppsala, Sweden
Location
Lulea, Sweden
Arms | Assigned Interventions |
---|---|
Experimental: Cohort 1 (2 arms) Period 1: randomized to either fasting IR or ER1. Period 2: Cross-over to either IR or ER1. Period 3: ER1 in fed conditions. | Drug: AZD1446 ER Fast, 90mg, p.o. capsule |
Experimental: Cohort 2 (2 arms) Period 1: randomized to either fasting IR or ER2. Period 2: Cross-over to either IR or ER2. Period 3: ER2 in fed conditions. | Drug: AZD1446 ER Moderate, 90mg, p.o. capsule |
Experimental: Cohort 3( 2 arms) Period 1: randomized to either fasting IR or ER3. Period 2: Cross-over to either IR or ER3. Period 3: ER3 in fed conditions. | Drug: AZD1446 ER Slow, 90mg, p.o. capsule |
Experimental: Cohort 4 (2 arms) Period 1: randomized to either fasting IR or MR4. Period 2: Cross-over to either IR or MR4. Period 3: MR4 in fed conditions. | Drug: AZD1446 MR Drug: AZD1446 IR, 90 mg p.o. capsule |
Experimental: Part 2: Extended/Modified release Extended/Modified release capsule to be determined | Drug: AZD1446 MR Drug: AZD1446 IR, 90 mg p.o. capsule |
Placebo Comparator: Part 2: Placebo | Drug: Placebo IR Drug: Placebo ER/MR |
This information is not intended to replace the informed medical advice or medical treatments of a healthcare professional. Only a physician can determine if a specific medicine is the correct treatment for a particular patient. If you have questions regarding any information contained in this site, you must consult a suitably qualified healthcare professional. Before prescribing any AstraZeneca products, Healthcare Professionals should view their country specific information.