NCT00687232

Brief Summary

The purpose is to investigate safety and tolerability of single and multiple ascending inhaled doses of AZD4818 in healthy Japanese male volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jan 2008

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

January 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 30, 2008

Completed
Last Updated

December 1, 2010

Status Verified

November 1, 2010

Enrollment Period

4 months

First QC Date

May 28, 2008

Last Update Submit

November 30, 2010

Conditions

Healthy

Keywords

Phase IJapanJapaneseinhalation

Outcome Measures

Primary Outcomes (2)

  • Incidence and nature of adverse Event, 12-lead ECG, BP, pulse rate, body temperature, spirometry

    During the study

  • Lab assessment

    During the study

Secondary Outcomes (1)

  • Pharmacokinetics

    During the study

Study Arms (2)

1

EXPERIMENTAL

AZD4818

Drug: AZD4818

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AZD4818DRUG

Dry powder, inhalation, b.i.d, 10 + 1/2 days or 20 + 1/2 days

1
PlaceboDRUG
2

Eligibility Criteria

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

You may qualify if:

  • Provision of informed consent
  • Body Mass Index (BMI) between 18.0-27.0 kg/m2
  • No clinically relevant abnormal findings

You may not qualify if:

  • Acute illness which requires medical intervention
  • Definite or suspected personal history of adverse drug reactions or drug hypersensitivity.
  • Clinical relevant disease or disorder (past or present)
  • A history of respiratory disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Osaka, Osaka, Japan

Location

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

AZD-4818

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michio Yagi

    Osaka Pharmacology Clinical Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 28, 2008

First Posted

May 30, 2008

Study Start

January 1, 2008

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

December 1, 2010

Record last verified: 2010-11

Locations

JP(1)