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

AstraZeneca

Status and phase

Terminated

Phase 1

Conditions

Healthy

Treatments

Drug: AZD1305

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00935025

D3190C00015

Details and patient eligibility

About

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.

Enrollment

45 estimated patients

Sex

Male

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

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