AZD7268 Single Ascending Dose Study in Healthy Japanese Subjects

A Phase I, Single Center, Randomized, Double-Blind, Placebo-Controlled Single Ascending Oral Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7268 in Healthy Japanese Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00912353

Acronym

JSAD

Enrollment

Registered

2009-06-03

Start date

2009-05-31

Completion date

2009-10-31

Last updated

2013-01-29

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, AZD7268

Brief summary

This is a Phase I, single center, randomized, double-blind, placebo-controlled single ascending oral dose study to assess the safety, tolerability and pharmacokinetics of AZD7268 in healthy Japanese subjects.

Interventions

DRUGAZD7268

Single Oral

DRUGPlacebo

Single Oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy Japanese male and female (of non-child bearing potential) subjects 20 to 45 years of age, inclusive * Body weight between 50 and 90 kg, inclusive, with a Body Mass Index (BMI) * 18 to ≤ 27 kg/m2

Exclusion criteria

* Clinically relevant disease or disorder (past or present), which in the opinion of the investigator, may either put the subject at risk because of participation in the study or influence the results or the subject's ability to participate in the study * Any clinically significant abnormalities in physical examination, vital signs, clinical chemistry, hematology or urinalysis results as judged by the investigator and/or sponsor * Smoking in excess of 5 cigarettes per day or equivalent within 30 days of Day 1

Design outcomes

Primary

Measure	Time frame
To asses the safety nature and incidence of adverse events, blood pressure, pulse rate, body temperature, physical examination, laboratory assessments (clinical chemistry, hematology, and urinalysis parameters), effects on ECG parameters, EEG recordings,	From screening period to follow-up, 44 days (maiximum).

Secondary

Measure	Time frame
To characterize the pharmacokinetics of AZD7268 and its metabolite(s) in plasma and urine.	Blood and urine sampling from pre-dose until 72 hrs post dose.
To collect and store DNA for future exploratory research	One blood sampling after randomisation

Countries

United States

Outcome results

None listed

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