NCT00912353

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started May 2009

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 1, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

January 29, 2013

Status Verified

August 1, 2010

Enrollment Period

5 months

First QC Date

June 1, 2009

Last Update Submit

January 28, 2013

Conditions

Healthy

Keywords

Phase IJapanese healthy volunteerAZD7268

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Study Arms (2)

AZD7268

EXPERIMENTAL
Drug: AZD7268

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AZD7268DRUG

Single Oral

AZD7268
PlaceboDRUG

Single Oral

Placebo

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)
  • to ≤ 27 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Gelndale, California, United States

Location

Study Officials

  • Mark Yen, MD

    California Clinical Trials

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2009

First Posted

June 3, 2009

Study Start

May 1, 2009

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

January 29, 2013

Record last verified: 2010-08

Locations

US(1)