MedDataX Logo

Phase I Multiple Ascending Dose Study for AZD 7268 in Healthy Volunteers

NCT ID: NCT00861718

Last Updated: 2009-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Multiple Ascending Dose Study

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Phase 1 Healthy Volunteer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AZD7268

Group Type EXPERIMENTAL

AZD7268

Intervention Type DRUG

Capsule, Oral, QD

AZD7268

Intervention Type DRUG

Capsule, Oral, BID

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Capsule, Oral BID

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AZD7268

Capsule, Oral, QD

Intervention Type DRUG

AZD7268

Capsule, Oral, BID

Intervention Type DRUG

Placebo

Capsule, Oral BID

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Provision of Informed Consent
* Healthy male subjects and female subjects (of non-child bearing potential)

* with suitable veins for cannulation or repeated venipuncture

Exclusion Criteria

* Inability to understand or cooperate with given information
* Any positive result on screening for human immune deficiency virus (HIV), Hepatitis B, or Hepatitis C test
* History of seizure (including infancy febrile seizures) or family history of seizure
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

AstraZeneca Pharmaceuticals

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sylvan Hurewitz, M.D.

Role: PRINCIPAL_INVESTIGATOR

AstraZeneca Clinical Pharmacology Unit, US

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D1151C00003

Identifier Type: -

Identifier Source: org_study_id