NCT00729443

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 4, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 7, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

November 13, 2008

Status Verified

November 1, 2008

Enrollment Period

4 months

First QC Date

August 4, 2008

Last Update Submit

November 10, 2008

Conditions

Healthy Volunteers

Keywords

Single dosePhase 1Safety of AZD3241tolerability of AZD3241

Outcome Measures

Primary Outcomes (1)

  • General tolerability and safety variables

    2 weeks

Secondary Outcomes (1)

  • pk

    approximately 48 hour

Study Arms (2)

1

EXPERIMENTAL
Drug: AZD3241

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AZD3241DRUG

single oral dose

1
PlaceboDRUG
2

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Stockholm, Sweden

Location

MeSH Terms

Interventions

AZD3241

Study Officials

  • Ingemar Bylesjö

    Astrazeneca Clinical Pharmacology Unit, Stockholm, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 4, 2008

First Posted

August 7, 2008

Study Start

July 1, 2008

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

November 13, 2008

Record last verified: 2008-11

Locations

SE(1)