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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: AZD6765

Study type: Interventional

Funder types: Industry

Identifiers

NCT00785915

D6702C00013

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: AZD6765

2

Placebo Comparator group

Description:

given (2 subjects in each ethnic/dose group)

Treatment:

Drug: Placebo