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

A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Extended Release Tablets of AZD3241 After Administration of Multiple Ascending Doses in Healthy Male and Female Volunteers Including Food Effect

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00914303

Enrollment

Registered

2009-06-04

Start date

2009-06-30

Completion date

2010-03-31

Last updated

2010-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Safety, tolerability, healthy, Healthy volunteer study

Brief summary

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.

Interventions

DRUGAZD3241

Oral Tablet, Repeated Administration

DRUGPlacebo Tablet

Oral Tablet. Repeated Administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

30 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Safety variables (adverse events, vital signs, ECG, safety lab)	Assessments performed at frequent timepoints during a 4-8 week period

Secondary

Measure	Time frame
To characterize the pharmacokinetics of AZD3241 in plasma	Frequent sampling occasions during some study days for a 4-8 weeks period

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026