NCT00867685

Brief Summary

The purpose of this study is to compare the liquid suspension form of AZD 2624 to a tablet form of the same drug. This study will also study the effect of food on the tablet form of the drug.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Mar 2009

Shorter than P25 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

March 1, 2009

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2009

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

April 30, 2009

Status Verified

April 1, 2009

First QC Date

March 18, 2009

Last Update Submit

April 29, 2009

Conditions

Healthy

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Serial blood draws will be used to measure the plasma levels of AZD2624 for the liquid suspension and the tablet formulation in a fed and fasted state.

    Seventeen blood draws will be collected during each treatment period for a total of 51 samples for the study.

Secondary Outcomes (1)

  • Safety will be measured by the collection of AEs, ECGs, physical exams, and vital signs.

    Subjects inquiry on AE daily, ECGs collected at 2 timepoints each period, clinical labs collected at 3 timepoints each period, physical exams completed 3 timepoints each period, and vital signs collected each day of each period

Study Arms (3)

Treatment A

EXPERIMENTAL

Single oral dose of 40 mg AZD2624 liquid suspension in a fasted state.

Drug: AZD2624

Treatment B

EXPERIMENTAL

Single oral dose of 40 mg (2x20mg tablets)AZD2624 in a fasted state.

Drug: AZD2624

Treatment C

EXPERIMENTAL

Single oral dose of 40 mg (2x20mg tablets) in a fed state.

Drug: AZD2624

Interventions

AZD2624DRUG

Single dose of 40 mg AZD2624 liquid suspension, PO

Treatment A

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy male and female volunteers

You may not qualify if:

  • Donation of plasma or blood products within one month of of screening
  • Clinically relevant abnormalities in physical examination, vital signs,ECG, clinical chemistry, hematology, or urinalysis.
  • Previous participation in an AD2624 study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Philadelphia, Pennsylvania, United States

Location

MeSH Terms

Interventions

3-((methylsulfonyl)amino)-2-phenyl-N-(1-phenylpropyl)quinolin-4-carboxamide

Study Officials

  • Sylvan Hurewitz, MD

    AstraZeneca Clinical Pharmacology Unit, US

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 18, 2009

First Posted

March 24, 2009

Study Start

March 1, 2009

Study Completion

April 1, 2009

Last Updated

April 30, 2009

Record last verified: 2009-04

Locations

US(1)