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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00729443
Recruitment Status : Completed
First Posted : August 7, 2008
Last Update Posted : November 13, 2008
Information provided by:

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

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: AZD3241 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official 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
Study Start Date : July 2008
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Arm Intervention/treatment
Experimental: 1 Drug: AZD3241
single oral dose

Placebo Comparator: 2 Drug: Placebo

Primary Outcome Measures :
  1. General tolerability and safety variables [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. pk [ Time Frame: approximately 48 hour ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00729443

Research Site
Stockholm, Sweden
Sponsors and Collaborators
Principal Investigator: Ingemar Bylesjö Astrazeneca Clinical Pharmacology Unit, Stockholm, Sweden

Responsible Party: Jarkko Kalliomäki, MD, Medical Science Director, Neuroscience alpha, AstraZeneca R&D Södertälje, Sweden Identifier: NCT00729443     History of Changes
Other Study ID Numbers: D0490C00012
EudractCT# 2008-002466-62
First Posted: August 7, 2008    Key Record Dates
Last Update Posted: November 13, 2008
Last Verified: November 2008

Keywords provided by AstraZeneca:
Single dose
Phase 1
Safety of AZD3241
tolerability of AZD3241