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

Healthy Clinical Trial

— JMAD  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00935025
• Other study ID #: D3190C00015
• Status: Terminated
• Phase: Phase 1
• First received: July 2, 2009
• Last updated: December 6, 2010
• Start date: July 2009
• Est. completion date: November 2009

Study information

• Verified date: December 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• AZD1305
single and multiple oral doses, extended-release capsule
• Placebo
single and multiple oral doses, capsule

Locations

Country	Name	City	State
United States	Research Site	Baltimore	Maryland
United States	Research Site	Glendale	California

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No