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

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ClinicalTrials.gov Identifier: NCT00886756
Recruitment Status : Completed
First Posted : April 23, 2009
Last Update Posted : August 19, 2009
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: AZD8529 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : April 2009
Study Completion Date : July 2009

Arm Intervention/treatment
Experimental: 1 Drug: AZD8529
Placebo Comparator: 2 Drug: Placebo

Primary Outcome Measures :
  1. 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). ]

Secondary Outcome Measures :
  1. To characterize the pharmacokinetics of AZD8529 in plasma and urine. [ Time Frame: Blood and urine sampling from pre-dose until 12 days post dose. ]
  2. To collect and store DNA for future exploratory research [ Time Frame: One blood sampling after randomisation. ]

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:   Male
Accepts Healthy Volunteers:   Yes

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.

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 ClinicalTrials.gov identifier (NCT number): NCT00886756

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

Responsible Party: AstraZeneca, MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00886756     History of Changes
Other Study ID Numbers: D1960C00003
First Posted: April 23, 2009    Key Record Dates
Last Update Posted: August 19, 2009
Last Verified: August 2009

Keywords provided by AstraZeneca:
Phase I
Japanese healthy volunteer