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

AstraZeneca77 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Healthy

Interventions

AZD3241DRUG

Oral Tablet, Repeated Administration

Placebo TabletDRUG

Oral Tablet. Repeated Administration

Eligibility

Sex: ALLMin age: 30 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Uppsala, Sweden

Outcomes

Primary Outcomes

Safety variables (adverse events, vital signs, ECG, safety lab)

Time frame: Assessments performed at frequent timepoints during a 4-8 week period

Secondary Outcomes

To characterize the pharmacokinetics of AZD3241 in plasma

Time frame: Frequent sampling occasions during some study days for a 4-8 weeks period

Data from ClinicalTrials.gov

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