Study to Evaluate Different Extended Release (ER)-Formulations and Multiple Ascending Dosing of AZD3241

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: AZD3241; Drug: Placebo Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT00914303

EudraCT No 2007-003145-33

D0490C00002

Details and patient eligibility

About

The aims of the study are to assess the safety, tolerability and pharmacokinetics of ER tablets of AZD3241 following multiple ascending doses administered to healthy male and female subjects including the effect of food.

Enrollment: 77 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and female subjects 30-65 years
• Body Mass Index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg

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
• Previous history of frequent pre-syncope or syncope

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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77 participants in 2 patient groups

AZD3241

Experimental group

Description:

AZD3241 Tablets

Treatment:

Drug: AZD3241

Placebo

Experimental group

Description:

Placebo Tablets

Treatment:

Drug: Placebo Tablet