NCT00767052

Brief Summary

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of multiple ascending oral doses of AZD1236 given to healthy young subjects for 13 days and to evaluate the single-dose relative bioavailability of the oral suspension and oral tablet formulations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_1

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 3, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 6, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

June 30, 2009

Status Verified

June 1, 2009

First QC Date

October 3, 2008

Last Update Submit

June 29, 2009

Conditions

Healthy Volunteer

Keywords

Healthy VolunteerSafetyTolerabilityPharmacokineticsAZD1236

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of AZD1236 by assessment of blood pressure, pulse rate, body temperature, laboratory variables, ECG and adverse events

    Assessments taken at screening visit, defined timepoints pre-dose and post-dose during treatment periods and follow up visit. Volunteers will be monitored throughout the study for adverse events.

Secondary Outcomes (1)

  • Pharmacokinetic profile: concentration of AZD1236 in blood

    Samples taken during Visit 2 in multiple dosing part at 41 points and Visit 2/3 in relative bioavailability part at 32 points.

Study Arms (4)

Active

EXPERIMENTAL

AZD1236 tablet

Drug: AZD1236

Placebo

PLACEBO COMPARATOR

Placebo tablet

Drug: Placebo

Relative bioavailability

OTHER

AZD1236 Oral suspension

Drug: AZD1236

Relative bioavailability tablet

OTHER

AZD1236 tablet

Drug: AZD1236

Interventions

AZD1236DRUG

75mg once daily or 75mg twice daily will be administered in multiple dose part.

Active
PlaceboDRUG

Placebo tablet matching to the active in multiple dose part.

Placebo

Eligibility Criteria

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

You may qualify if:

  • Provision of signed informed consent prior to any study specific procedures
  • Body Mass Index (BMI) between 19-27 kg/m2

You may not qualify if:

  • Receipt of another investigational drug in the 4 months before dosing in this study
  • Acute illness which requires medical intervention within 2 weeks of Visit 2.
  • Abnormal resting BP and pulse rate (after resting for 10 minutes). Supine blood pressure \> 140 mmHg systolic or \>90 mmHg diastolic, pulse\<= 50 or =\> 90 beats per minute

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Osaka, Osaka, Japan

Location

MeSH Terms

Interventions

4-((5-chloro-2-pyridinyl)oxy)-1-((((4S)-4-methyl-2,5-dioxo-4-imidazolidinyl)methyl)sulfonyl)-piperidine

Study Officials

  • Shunji Matsuki, MD PhD

    Kyushu Clinical Pharmacology Research Clinic

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 3, 2008

First Posted

October 6, 2008

Study Start

September 1, 2008

Study Completion

December 1, 2008

Last Updated

June 30, 2009

Record last verified: 2009-06

Locations

JP(1)