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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00785915
Recruitment Status : Completed
First Posted : November 5, 2008
Last Update Posted : October 13, 2014
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Healthy Drug: AZD6765 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

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

Primary Outcome Measures :
  1. Safety and tolerability; Adverse events (AEs), vital signs, physical examinations, ECGs and clinical laboratory assessments [ Time Frame: During the study ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00785915

United States, California
Research Site
Glendale, California, United States
United States, Maryland
Research Site
Baltimore, Maryland, United States
Sponsors and Collaborators
Principal Investigator: Mark Yen, MD California Clinical Trials

Additional Information:
Responsible Party: AstraZeneca Identifier: NCT00785915     History of Changes
Other Study ID Numbers: D6702C00013
First Posted: November 5, 2008    Key Record Dates
Last Update Posted: October 13, 2014
Last Verified: October 2014

Keywords provided by AstraZeneca:
Japanese and Caucasian Healthy Volunteers
Phase I study
Single and multiple Ascending Dose
Japanese volunteers