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

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00935025

Acronym

JMAD

Enrollment

Registered

2009-07-08

Start date

2009-07-31

Completion date

2009-11-30

Last updated

2010-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Phase I, Japanese healthy volunteer, AZD1305, Japanese and Caucasian

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.

Interventions

DRUGAZD1305

single and multiple oral doses, extended-release capsule

DRUGPlacebo

single and multiple oral doses, capsule

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

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

Design outcomes

Primary

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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026