NCT01116258

Brief Summary

The purpose of this study is to determine the safety, tolerability and blood levels of AZD5847 after daily oral dosing for 14 days.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Apr 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

April 1, 2010

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 4, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

October 11, 2010

Status Verified

October 1, 2010

Enrollment Period

6 months

First QC Date

April 29, 2010

Last Update Submit

October 8, 2010

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 to 52 days(includes upto 28 days for screening)

Secondary Outcomes (1)

  • 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: AZD5847

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AZD5847DRUG

oral suspension, 15 days

1
PlaceboDRUG

oral suspension, 15 days

2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI between 18-30

You may not qualify if:

  • Use of drugs that inhibit or induce cytochrome P450 3A4 enzymes
  • History of presence of gastrointestinal, hepatic or renal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Overland Park, Kansas, United States

Location

MeSH Terms

Interventions

posizolid

Study Officials

  • Andrew Shaw

    AstraZeneca

    STUDY DIRECTOR

  • Brendan Smyth

    AstraZeneca

    STUDY CHAIR

  • David Melnick

    AstraZeneca

    STUDY DIRECTOR

  • Eleanor Lisbon

    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

Study Record Dates

First Submitted

April 29, 2010

First Posted

May 4, 2010

Study Start

April 1, 2010

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

October 11, 2010

Record last verified: 2010-10

Locations

US(1)