NCT00914303

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jun 2009

Typical duration for phase_1 healthy

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

First Submitted

Initial submission to the registry

June 1, 2009

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

April 6, 2010

Status Verified

April 1, 2010

Enrollment Period

9 months

First QC Date

June 1, 2009

Last Update Submit

April 5, 2010

Conditions

Healthy

Keywords

SafetytolerabilityhealthyHealthy volunteer study

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (1)

  • To characterize the pharmacokinetics of AZD3241 in plasma

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

Study Arms (2)

AZD3241

EXPERIMENTAL

AZD3241 Tablets

Drug: AZD3241

Placebo

EXPERIMENTAL

Placebo Tablets

Drug: Placebo Tablet

Interventions

AZD3241DRUG

Oral Tablet, Repeated Administration

AZD3241
Placebo TabletDRUG

Oral Tablet. Repeated Administration

Placebo

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Uppsala, Sweden

Location

MeSH Terms

Interventions

AZD3241

Study Officials

  • Rolf Karlsten, MD

    Medical Science Director AstraZeneca R&D Södertälje.

    STUDY DIRECTOR

  • Wolfgang Kuhn, MD, PhD

    Quintiles AB Phase I Unit, Uppsala, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 1, 2009

First Posted

June 4, 2009

Study Start

June 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

April 6, 2010

Record last verified: 2010-04

Locations

SE(1)