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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT00785915

Run by

AstraZeneca

People needed

40

Starts

2008-11-01

Expected to finish

2009-03-01

Last updated by the study team

2014-10-13

Who can join

Age: 20 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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