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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00785915
First received: November 3, 2008
Last updated: March 17, 2009
Last verified: March 2009
  Purpose

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 Intervention Phase
Healthy
Drug: AZD6765
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Safety and tolerability; Adverse events (AEs), vital signs, physical examinations, ECGs and clinical laboratory assessments [ Time Frame: During the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetic - Pharmacokinetic parameters for AZD6765 in plasma and urine [ Time Frame: During residential period ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: November 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00785915

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

No publications provided

Responsible Party: United States: Institutional Review Board, AstraZeneca LP
ClinicalTrials.gov Identifier: NCT00785915     History of Changes
Other Study ID Numbers: D6702C00013
Study First Received: November 3, 2008
Last Updated: March 17, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
AZD6765
Japanese and Caucasian Healthy Volunteers
Phase I study
Single and multiple Ascending Dose
Japanese volunteers

ClinicalTrials.gov processed this record on August 28, 2014