AZD1305 Single and Multiple Ascending Dose Study in Healthy Japanese and Caucasian Subjects (JMAD)

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: NCT00935025
Recruitment Status : Terminated
First Posted : July 8, 2009
Last Update Posted : December 7, 2010
Information provided by:

Brief Summary:
This is a phase I, single-blind, randomized, placebo-controlled single and repeated ascending dose study to assess the safety, tolerability and pharmacokinetics with oral doses of AZD1305 extended-release capsules in healthy male Japanese and Caucasian subjects. Three (or four if needed) dose levels will be given to Japanese subjects and one of the doses will also be given to Caucasian subjects.

Condition or disease Intervention/treatment Phase
Healthy Drug: AZD1305 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: A Single-center, Single-blind, Randomized, Placebo-controlled, Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics After Single and Multiple Ascending Oral Doses of AZD1305 Extended-release Capsules in Healthy Male Japanese and Caucasian Subjects
Study Start Date : July 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Arm Intervention/treatment
Experimental: 1, AZD1305 Drug: AZD1305
single and multiple oral doses, extended-release capsule

Placebo Comparator: 2, Placebo Drug: Placebo
single and multiple oral doses, capsule

Primary Outcome Measures :
  1. Adverse events, ECG variables, vital signs, physical examination, laboratory variables, body temperature and weight [ Time Frame: During the study, from screening period to follow-up, 50 days approximately ]

Secondary Outcome Measures :
  1. Pharmacokinetic variables of AZD1305 by assessment of drug concentrations in plasma and urine after single and repeated oral doses [ Time Frame: From predose until 48 hrs post last dose ]

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 Japanese and Caucasian male subjects 20 to 45 years of age inclusive
  • Body weight between 50 and 85 kg, inclusive, with a Body Mass Index (BMI) ≥19 to ≤ 27 kg/m2

Exclusion Criteria:

  • Clinically significant illness, surgical procedure or trauma, within two weeks preceding the pre-entry visit until first administration of IP, as judged by the investigator
  • History of clinically significant gastrointestinal, mental, cardiac, renal or hepatic disorder, or other significant disease as judged by the investigator
  • Habitual smoker (daily use) of tobacco or daily use of nicotine-containing products

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): NCT00935025

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, M.D. California Clinical Trials

Responsible Party: MSD, AstraZeneca Identifier: NCT00935025     History of Changes
Other Study ID Numbers: D3190C00015
First Posted: July 8, 2009    Key Record Dates
Last Update Posted: December 7, 2010
Last Verified: December 2010

Keywords provided by AstraZeneca:
Phase I
Japanese healthy volunteer
Japanese and Caucasian