NCT00796965

Brief Summary

Single Ascending Dose Study

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2008

Shorter than P25 for phase_1

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

November 20, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 24, 2008

Completed
7 days until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

August 19, 2009

Status Verified

August 1, 2009

First QC Date

November 20, 2008

Last Update Submit

August 18, 2009

Conditions

Healthy Volunteer

Keywords

Phase 1

Outcome Measures

Primary Outcomes (1)

  • To assess the safety and tolerability of single ascending dose administration of AZD7268 when given orally to healthy male subjects and female subjects of non-childbearing potential.

    Safety assessments are made at each visit, at least daily, during the study.

Secondary Outcomes (2)

  • To characterize the pharmacokinetics of AZD7268 in plasma and urine.

    Blood and urine samples will be taken during the study.

  • To assess the effect of food on the safety and pharmacokinetic profile of AZD7268.

    Safety assessments and blood and urine samples will be taken throughout the study.

Study Arms (2)

1

EXPERIMENTAL
Drug: AZD7268

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AZD7268DRUG

Solution/Capsule, Oral, once daily

1
PlaceboDRUG
2

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Provision of Informed Consent
  • Healthy male subjects and female subjects (of non-child bearing potential) with suitable veins for cannulation or repeated venipuncture

You may not qualify if:

  • Inability to understand or cooperate with given information
  • Positive human immune deficiency virus (HIV), Hepatitis B, or Hepatitis C test
  • Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology, and urinanalysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Philadelphia, Pennsylvania, United States

Location

Study Officials

  • Sylvan Hurewitz, M.D.

    AstraZeneca Clinical Pharmacology Unit, US

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 20, 2008

First Posted

November 24, 2008

Study Start

December 1, 2008

Study Completion

March 1, 2009

Last Updated

August 19, 2009

Record last verified: 2009-08

Locations

US(1)