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OpenTrials
Completed

NCT Number: NCT01064388

A Study in Healthy Volunteers to Assess Safety and Blood Levels of AZD9742 After Multiple Doses Over 14 Days

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

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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

  • BMI between 19-30

Exclusion criteria

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

Treatment and study plan

AZD9742

Drug

IV infusion, 15 days

Placebo

Drug

IV infusion, 15 days

Primary outcomes

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

    Time frame: 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

    Time frame: PK-sampling during 14 pre-defined study days for PK profiling

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase I, Single Center, Double-blind Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Intravenous AZD9742 After Administration of Multiple Ascending Doses for 14 Days in Healthy Male and Female Subjects

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 8, 2010
Registry last updated
Jun 6, 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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