AZD7325 Single Ascending Dose Study in Healthy Male Japanese Subjects (JSAD)

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: NCT00769899
Recruitment Status : Completed
First Posted : October 9, 2008
Last Update Posted : March 18, 2009
Information provided by:

Brief Summary:
This is a Phase I randomized double-blind, placebo-controlled, single centre study to assess the safety, tolerability and pharmacokinetics of AZD7325 following single ascending dose administration to healthy male Japanese volunteers.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: AZD7325 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 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,Randomised,Double-Blind,Placebo-Controlled Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7325 in Healthy Male Japanese Subjects
Study Start Date : October 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Arm Intervention/treatment
Experimental: 1 Drug: AZD7325
Capsule for oral, single dose
Placebo Comparator: 2 Drug: Placebo
Placebo capsule for oral, single dose

Primary Outcome Measures :
  1. Safety and tolerabilityThe nature and incidence of adverse events (AEs), vital signs,physical examinations,electrocardiograms (ECGs)and laboratory assessments. [ Time Frame: During the study ]

Secondary Outcome Measures :
  1. Pharmacokinetic parameters for AZD7325 [ Time Frame: During residential period ]
  2. Genetic analysis of the genes involved in the pharmacokinetics and safety and tolerability to AZD7325 treatment may be performed. Participation in the exploratory genetic study is optional for the subjects. [ Time Frame: During the study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Body mass index (BMI) : 18 to 27 kg/m 2

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 medication or herbal preparation within 14 days of Study day 1 through the Follow-up Visit other than paracetamol (up to 3 g/day)
  • Smoking in excess of 5 cigarettes per day or the equivalent within 28 days prior to the first study day or inability to refrain from smoking during the study confinement period

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): NCT00769899

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

Responsible Party: Mark A. Smith, MD, PhD Senior Medical Science Director, AstraZeneca LP Identifier: NCT00769899     History of Changes
Other Study ID Numbers: D1140C00010
First Posted: October 9, 2008    Key Record Dates
Last Update Posted: March 18, 2009
Last Verified: March 2009

Keywords provided by AstraZeneca:
Japanese Healthy Volunteers
Phase I study
Single Ascending Dose