A Bioavailability Study Comparing Modified-release Capsules and Immediate Release Capsules in Fed and Fasting Conditions

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: AZD1446; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01092299

2009-017702-36 (EudraCT Number)

D1950C00008

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body mass index (BMI) between 19 and 30 kg/m2
• Clinically normal findings on physical examination

Exclusion criteria

• History of any clinically significant disease or disorder
• History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
• History or present symptoms or signs of severe allergy/hypersensitivity reactions including severe food allergy, as judged by the investigator

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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62 participants in 6 patient groups, including a placebo group

Cohort 1 (2 arms)

Experimental group

Description:

Period 1: randomized to either fasting IR or ER1. Period 2: Cross-over to either IR or ER1. Period 3: ER1 in fed conditions.

Treatment:

Drug: AZD1446

Drug: AZD1446

Drug: AZD1446

Drug: AZD1446

Drug: AZD1446

Cohort 2 (2 arms)

Experimental group

Description:

Period 1: randomized to either fasting IR or ER2. Period 2: Cross-over to either IR or ER2. Period 3: ER2 in fed conditions.

Treatment:

Drug: AZD1446

Drug: AZD1446

Drug: AZD1446

Drug: AZD1446

Drug: AZD1446

Cohort 3( 2 arms)

Experimental group

Description:

Period 1: randomized to either fasting IR or ER3. Period 2: Cross-over to either IR or ER3. Period 3: ER3 in fed conditions.

Treatment:

Drug: AZD1446

Drug: AZD1446

Drug: AZD1446

Drug: AZD1446

Drug: AZD1446

Cohort 4 (2 arms)

Experimental group

Description:

Period 1: randomized to either fasting IR or MR4. Period 2: Cross-over to either IR or MR4. Period 3: MR4 in fed conditions.

Treatment:

Drug: AZD1446

Drug: AZD1446

Drug: AZD1446

Drug: AZD1446

Drug: AZD1446

Part 2: Extended/Modified release

Experimental group

Description:

Extended/Modified release capsule to be determined

Treatment:

Drug: AZD1446

Drug: AZD1446

Drug: AZD1446

Drug: AZD1446

Drug: AZD1446

Part 2: Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo