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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00769899
First received: October 8, 2008
Last updated: March 17, 2009
Last verified: March 2009
  Purpose

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 Intervention Phase
Healthy Volunteer
Drug: AZD7325
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,Randomised,Double-Blind,Placebo-Controlled Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7325 in Healthy Male Japanese Subjects

Further study details as provided by AstraZeneca:

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

Secondary Outcome Measures:
  • Pharmacokinetic parameters for AZD7325 [ Time Frame: During residential period ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: October 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: AZD7325
Capsule for oral, single dose
Placebo Comparator: 2 Drug: Placebo
Placebo capsule for oral, single dose

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT00769899

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: Mark A. Smith, MD, PhD Senior Medical Science Director, AstraZeneca LP
ClinicalTrials.gov Identifier: NCT00769899     History of Changes
Other Study ID Numbers: D1140C00010
Study First Received: October 8, 2008
Last Updated: March 17, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
AZD7325
Japanese Healthy Volunteers
Phase I study
Single Ascending Dose

ClinicalTrials.gov processed this record on November 24, 2014