AZD6765 Single and Multiple Ascending Dose Study in Healthy Male and Female Japanese and Caucasian Subjects (JSAD/JMAD)

A Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6765 in Healthy Male and Female Japanese and Caucasian 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 AZD6765 in healthy male and female Japanese and Caucasian subjects

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: AZD6765; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Body mass index (BMI): 18 to 27 kg/m 2
• Female subjects must be postmenopausal for at least 1 year, surgically sterile, or using a reliable method of contraception at screening.
• Male subjects must be willing to use accepted contraceptive methods, avoid unprotected sex, and donating sperm until 3 months after drug administration.

Exclusion Criteria:

• Clinically relevant disease and/or abnormalities (past or present)
• Clinically relevant abnormalities in physical examinations,vital signs,clinical chemistry, hematology or urinalysis at screening as judged by the investigator
• Use of any prescription medication within 14 days of Day 1
• Use of over-the-counter (OTC) medication (with the exception of acetaminophen), vitamin/nutritional supplements and herbal preparations within 14 days of Day 1
• Smoking in excess of 5 cigarettes per day or the equivalent within 28 days of Day 1

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	Drug: AZD6765; single administration and once daily for 5 days
Placebo Comparator: 2; given (2 subjects in each ethnic/dose group)	Drug: Placebo; single administration and once daily for 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability; Adverse events (AEs), vital signs, physical examinations, ECGs and clinical laboratory assessments	During the study

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetic - Pharmacokinetic parameters for AZD6765 in plasma and urine	During residential period
Genetics; Collect blood samples for optional exploratory genetic studies focusing on identification of genes that influence the disposition, efficacy, safety and tolerability of AZD6765.	During the study

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

Helpful Links

• D6702C00013 Clinical Study Report Synopsis

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: November 3, 2008
• First Submitted That Met QC Criteria: November 4, 2008
• First Posted (Estimate): November 5, 2008

Study Record Updates

• Last Update Posted (Estimate): October 13, 2014
• Last Update Submitted That Met QC Criteria: October 10, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Phase I study; AZD6765; Japanese and Caucasian Healthy Volunteers; Single and multiple Ascending Dose; Japanese volunteers
• Other Study ID Numbers: D6702C00013