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AZD8529 Single Ascending Dose Study in Healthy Japanese Subjects (JSAD)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00886756
First received: April 21, 2009
Last updated: August 18, 2009
Last verified: August 2009
History of Changes
  Purpose

This is a Phase I, double-blind, placebo-controlled, randomised within each dose group, single ascending dose study, with the objective to assess the safety, tolerability and pharmacokinetic profile of AZD8529 in healthy Japanese subjects.


Condition Intervention Phase
Healthy
 Drug: AZD8529
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: Basic Science
Official Title: A Phase I, Single-Centre, Randomised, Double-Blind, Placebo Controlled Single-Ascending Dose, Study to Assess the Safety, Tolerability, Pharmacokinetics of AZD8529 in Healthy Male Japanese Subjects

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To asses the safety:Adverse events, vital signs, physical examinations, telemetry, dECGs, clinical chemistry and haematology labs including testosterone, prolactin, LH, FSH and TSH, and urinalysis. [ Time Frame: From screening period to follow-up, 42 days (maiximum). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To characterize the pharmacokinetics of AZD8529 in plasma and urine. [ Time Frame: Blood and urine sampling from pre-dose until 12 days post dose. ] [ Designated as safety issue: No ]
  • To collect and store DNA for future exploratory research [ Time Frame: One blood sampling after randomisation. ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: April 2009
Study Completion Date: July 2009
Arms Assigned Interventions
Experimental: 1 Drug: AZD8529
Oral
Placebo Comparator: 2 Drug: Placebo
Oral

  Eligibility

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

Inclusion Criteria:

  • Healthy male Japanese subjects aged 20 to 45 years (inclusive)
  • Have a body mass index (BMI) between 18 and 27 kg/m 2 (inclusive) and weigh at least 50 kg.least 50 kg.

Exclusion Criteria:

  • History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
  • Any clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, haematology or urinalysis as judged by the Investigator and/or Sponsor.
  • Smoking in excess of 5 cigarettes per day or the equivalent within 28 days of Day 1.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00886756

Locations
United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Ulrike Lorch, MD MFPM FRCA Richmond Pharmacology Limited
  More Information

No publications provided

Responsible Party: AstraZeneca, MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00886756     History of Changes
Other Study ID Numbers: D1960C00003, 2009-009940-22
Study First Received: April 21, 2009
Last Updated: August 18, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
Phase I
Japanese healthy volunteer
AZD8529

ClinicalTrials.gov processed this record on May 21, 2013