AZD6765 Single and Multiple Ascending Dose Study in Healthy Male and Female Japanese and Caucasian Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: AZD6765; Drug: Placebo

• Registration Number: NCT00785915
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-03
• Study First Submitted QC: 2008-11-04
• Study First Posted: 2008-11-05
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-10
• Last Update Posted: 2014-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AZD6765	-
2	Placebo	given (2 subjects in each ethnic/dose group)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇺🇸 Baltimore, Maryland, United States