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OpenTrials
Completed

NCT Number: NCT00914303

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

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.

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Key information

Conditions

Healthy

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Uppsala, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD3241

Drug

Oral Tablet, Repeated Administration

Placebo Tablet

Drug

Oral Tablet. Repeated Administration

Primary outcomes

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

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

Secondary outcomes

  1. To characterize the pharmacokinetics of AZD3241 in plasma

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 4, 2009
Registry last updated
Apr 6, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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