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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: AZD9742; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Dose level A, B, C and optional Dose level D and E: single administration and one to three times daily for 6 days (Japanese n=8)	Drug: AZD9742; IV Formulation
Placebo Comparator: 2; placebo given (2 subjects in each dose group)	Drug: Placebo; IV Formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 18-22 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Characterize the Pharmacokinetics of AZD9742 in blood and urine	PK-sampling during 14 pre-defined study days for PK profiling

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Mark Yen, M..D., California Clinical Trials

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: April 28, 2010
• First Submitted That Met QC Criteria: April 29, 2010
• First Posted (Estimate): April 30, 2010

Study Record Updates

• Last Update Posted (Estimate): August 3, 2010
• Last Update Submitted That Met QC Criteria: August 2, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: Phase I; Single and Multiple Ascending Dose; AZD9742; Japanese Healthy Volunteers
• Other Study ID Numbers: D2690C00003