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

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

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.

Study Overview

• Status: Terminated
• Conditions: Healthy
• Intervention / Treatment: Drug: AZD1305; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States
      • Research Site
  • Maryland
    • Baltimore, Maryland, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse events, ECG variables, vital signs, physical examination, laboratory variables, body temperature and weight	During the study, from screening period to follow-up, 50 days approximately

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetic variables of AZD1305 by assessment of drug concentrations in plasma and urine after single and repeated oral doses	From predose until 48 hrs post last dose

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Mark Yen, M.D., California Clinical Trials

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: July 2, 2009
• First Submitted That Met QC Criteria: July 6, 2009
• First Posted (Estimate): July 8, 2009

Study Record Updates

• Last Update Posted (Estimate): December 7, 2010
• Last Update Submitted That Met QC Criteria: December 6, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: Phase I; AZD1305; Japanese healthy volunteer; Japanese and Caucasian
• Other Study ID Numbers: D3190C00015