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

This study has been terminated.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00935025
First received: July 2, 2009
Last updated: December 6, 2010
Last verified: December 2010
  Purpose

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 Intervention Phase
Healthy
Drug: AZD1305
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: July 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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
  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: NCT00935025

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, M.D. California Clinical Trials
  More Information

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00935025     History of Changes
Other Study ID Numbers: D3190C00015
Study First Received: July 2, 2009
Last Updated: December 6, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Phase I
Japanese healthy volunteer
AZD1305
Japanese and Caucasian

ClinicalTrials.gov processed this record on October 21, 2014