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CompletedNCT01030224Updated Jul 27, 2012

This is a Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of AZD9742 After Single IV Doses in Healthy Subjects

A Phase 1 interventional study of AZD9742 and Placebo to match AZD9742 in Healthy, sponsored by AstraZeneca. Completed at 1 site in United States. Open to participants aged 23 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-07-27.

Sponsored by AstraZeneca · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
23 Years to 45 Years
Sex
All
01

Study summary

The main purpose of this study is to assess the safety, tolerability and PK of AZD9742 after single IV doses.

02

Conditions studied

  • Healthy

Keywords

  • Healthy volunteer
  • First time in human
03

In context

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
23 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Provision of signed and dated, written informed consent prior to any study specific procedures.
  • Clinically normal physical findings and laboratory values as judged by the investigator with normal ECG.
  • Healthy male and female volunteers. Females must be of non childbearing potential.

Exclusion criteria

Exclusion Criteria:

  • Clinically significant illness or clinically relevant trauma, as judged by the investigator, within 4 weeks of the first administration of the Investigational Product
  • History of any disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    AZD9742 IV Infusion

    Active

    Drug: AZD9742

  • Placebo comparator
    Placebo to AZD9742 IV Infusion

    Placebo

    Drug: Placebo to match AZD9742

Interventions

  • DrugAZD9742

    Increasing single IV infusion doses of AZD9742 given to approximately 6 cohorts of 8 subjects each (6 on active and 2 on placebo). Specific doses will be selected by the safety review committee

  • DrugPlacebo to match AZD9742

    Single IV infusion of AZD9742 placebo given to approximately 6 cohorts of 8 subjects each (6 on active and 2 on placebo)

06

What researchers measure

Primary outcomes

  1. Safety and tolerability of AZD9742 will be assessed by incidence and severity of AE's, abnormalities in vital signs, ECG's, telemetry, clinical laboratory assessments, physical exams and withdrawals

    Time frame: Assessments taken at Visit 1 (enrollment), defined timepoints pre-dose and post-dose during Visit 2 (residential period) and at Visit 3 (follow up). Volunteers will be monitored througout the study from Visit 1 through Visit 3 for adverse events.

Secondary outcomes

  1. Pharmacokinetic profile: to characterize the pharmacokinetics of AZD9742 in blood and urine

    Time frame: Samples taken during Visit 2 (residential period) at defined timepoints pre-dose and post-dose.

07

Study locations

1 site
  • Research Site
    Overland Park, Kansas, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01030224
Lead sponsor
AstraZeneca
Collaborators
Quintiles, Inc.
Responsible party
Sponsor
First posted
Dec 11, 2009
Start date
Nov 2009
Primary completion
Mar 2010
Completion
Mar 2010
Last update
Jul 27, 2012

Study contacts

Dr. Ralph A Schutz
principal investigator · Quintiles, Inc.
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.

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