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OpenTrials
Completed

NCT Number: NCT01030224

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

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

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Key information

Conditions

Healthy

Age range

23 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Overland Park, Kansas, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

AZD9742

Drug

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

Placebo to match AZD9742

Drug

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

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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Quintiles, Inc.

Registry information

Official study title

A Phase-1, Single Center, Double Blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Intravenous AZD9742 After Single Ascending Doses in Healthy Male and Female Subjects

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 11, 2009
Registry last updated
Jul 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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