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OpenTrials
Completed

NCT Number: NCT00729443

Investigating Safety, Tolerability and Pharmakinetics When Giving Single and Fractionated Doses of AZD3241 to Healthy Volunteers

The study is carried out in order to investigate safety, tolerability and pharmacokinetics after administrating single and fractionated doses of AZD3241 to healthy volunteers

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Key information

Conditions

Healthy Volunteers

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Stockholm, Sweden

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Provision of informed consent
  • Body Mass Index (BMI) 19 to 30 kg/m2 inclusive
  • Clinically normal physical findings, including BP, pulse rate, ECG and laboratory findings, as judged by the investigator

Exclusion criteria

  • Clinically significant illness within the 2 weeks prior to the administration of the investigational product
  • Heart rate (resting, recumbent) <50 bmp or >85 bmp
  • History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity as judged by the investigator

Treatment and study plan

AZD3241

Drug

single oral dose

Placebo

Drug

Primary outcomes

  1. General tolerability and safety variables

    Time frame: 2 weeks

Secondary outcomes

  1. pk

    Time frame: approximately 48 hour

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Single-Centre, Placebo-Controlled, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AZD3241 Following Administration of Single Ascending (Part A) and Fractionated Ascending (Part B) Oral Doses to Young Healthy Volunteers

Acronym: SAD

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Aug 7, 2008
Registry last updated
Nov 13, 2008

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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