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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00729443
First received: August 4, 2008
Last updated: November 10, 2008
Last verified: November 2008
  Purpose

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 Intervention Phase
Healthy Volunteers
Drug: AZD3241
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • General tolerability and safety variables [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • pk [ Time Frame: approximately 48 hour ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: July 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD3241
single oral dose
Placebo Comparator: 2 Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00729443

Locations
Sweden
Research Site
Stockholm, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Ingemar Bylesjö Astrazeneca Clinical Pharmacology Unit, Stockholm, Sweden
  More Information

No publications provided

Responsible Party: Jarkko Kalliomäki, MD, Medical Science Director, Neuroscience alpha, AstraZeneca R&D Södertälje, Sweden
ClinicalTrials.gov Identifier: NCT00729443     History of Changes
Other Study ID Numbers: D0490C00012, EudractCT# 2008-002466-62
Study First Received: August 4, 2008
Last Updated: November 10, 2008
Health Authority: Sweden: Medical Products Agency

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

ClinicalTrials.gov processed this record on September 18, 2014