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Completed

NCT Number: NCT01114152

AZD9742 Single and Multiple Ascending Dose Study in Healthy Male and Female Japanese Subjects

This is a Phase I randomized double-blind, placebo-controlled, single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of AZD9742 in healthy male and female Japanese subjects

Completed

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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

Glendale, California, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • female (non-childbearing potential)
  • Body mass index (BMI) : 17 to 27 kg/m 2

Exclusion criteria

  • History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
  • History or presence of gastrointestinal, hepatic, or renal disease or any otherHistory or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
  • Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product

Treatment and study plan

AZD9742

Drug

IV Formulation

Placebo

Drug

IV Formulation

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 18-22 days

Secondary outcomes

  1. 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 Single and Multiple Ascending Doses of Intravenous AZD9742 in Healthy Male and Female Japanese Subjects

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 30, 2010
Registry last updated
Aug 3, 2010

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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