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

• Sponsor: AstraZeneca (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00935025
• Collaborator: (none)
• Enrollment: 45
• Locations: 2
• Arms: 2
• Duration (Months): 4
• Patients Per Site: 22.5
• Patients Per Site Per Month: 5.6

Study Details

Study Description

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 Design

• Study Type: Interventional
• Anticipated 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: Jul 1, 2009
• Actual Primary Completion Date: Nov 1, 2009
• Actual Study Completion Date: Nov 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 45 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Glendale	California	United States
2	Research Site	Baltimore	Maryland	United States

Sponsors and Collaborators

• AstraZeneca

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00935025
• Other Study ID Numbers: D3190C00015
• First Posted: Jul 8, 2009
• Last Update Posted: Dec 7, 2010
• Last Verified: Dec 1, 2010

• Keywords provided by , ,: Phase I; Japanese healthy volunteer; AZD1305; Japanese and Caucasian

Study Results

No Results Posted as of Dec 7, 2010