NCT01064388

Brief Summary

The purpose of this study is to determine the safety, tolerability and blood levels of AZD9742 after daily dosing for 14 days.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Feb 2010

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

Study Start

First participant enrolled

February 1, 2010

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 8, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

June 6, 2012

Status Verified

June 1, 2012

Enrollment Period

6 months

First QC Date

February 3, 2010

Last Update Submit

June 5, 2012

Conditions

Healthy

Keywords

Safety

Outcome Measures

Primary Outcomes (1)

  • Safety variables (adverse events, vital signs, physical examinations, clinical laboratory assessments, 12-lead ECG, digital ECG, telemetry)

    collected prior to treatment, during treatment and follow-up for a total of 25-30 days.

Secondary Outcomes (1)

  • To characterize the Pharmacokinetics of AZD9742 in blood and urine

    PK-sampling during 14 pre-defined study days for PK profiling

Study Arms (2)

1

EXPERIMENTAL
Drug: AZD9742

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AZD9742DRUG

IV infusion, 15 days

1
PlaceboDRUG

IV infusion, 15 days

2

Eligibility Criteria

Age23 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI between 19-30

You may not qualify if:

  • Positive Fecal Occult Blood Test
  • Prescriptions that inhibit liver function
  • Received flu/H1N1 vaccine within 2 weeks before first dose

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Overland Park, Kansas, United States

Location

Study Officials

  • Andrew Shaw

    AstraZeneca

    STUDY DIRECTOR

  • Brendan Smyth

    AstraZeneca

    STUDY CHAIR

  • David Melnick

    AstraZeneca

    STUDY DIRECTOR

  • Ralph Schutz

    Quintiles, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 3, 2010

First Posted

February 8, 2010

Study Start

February 1, 2010

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

June 6, 2012

Record last verified: 2012-06

Locations

US(1)