NCT00908934

Brief Summary

The aims of this study are to compare the blood levels achieved with a new formulation of AZD9056 to an existing formulation of AZD9056 used in previous studies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started May 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 27, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

July 23, 2009

Status Verified

July 1, 2009

First QC Date

May 22, 2009

Last Update Submit

July 22, 2009

Conditions

Healthy

Keywords

Relative BioavailabilityAZD9056

Outcome Measures

Primary Outcomes (1)

  • Relative bioavailability of AZD9056 using PK variables Cmax and AUC

    For each study period, intensive sampling occasions on day 1: half hourly after dosing until 4 hours, then 4,6,8 and 12 hours post dose, with once daily sampling on days 2 to 7

Secondary Outcomes (2)

  • Descriptive PK parameters for AZD9056 using PK variables (tmax, AUC(0-t), t1/2, CL/F and Vz/F)

    For each study period, intensive sampling occasions on day 1: half hourly after dosing until 4 hours, then 4,6,8 and 12 hours post dose, with once daily sampling on days 2 to 7

  • Safety variables (adverse events, safety lab, blood pressure, pulse, ECG)

    Frequent sampling occasions throughout the study period

Study Arms (2)

1

EXPERIMENTAL

50 or 400 mg AZD9056, Test formulation

Drug: AZD9056 formulation Phase III 50 mg (T)Drug: AZD9056 formulation Phase III 200 mg (T)

2

EXPERIMENTAL

50 or 400 mg AZD9056, Reference formulation

Drug: AZD9056 formulation Phase IIb 50 mg (R)Drug: AZD9056 formulation Phase IIb 200mg (R)

Interventions

AZD9056 formulation Phase III 50 mg (T)DRUG

Given as 50 mg tablet (T)

1
AZD9056 formulation Phase IIb 50 mg (R)DRUG

Given as 50 mg tablet (R)

2
AZD9056 formulation Phase III 200 mg (T)DRUG

Given as 400 mg (2 x 200 mg tablet (T))

1
AZD9056 formulation Phase IIb 200mg (R)DRUG

Given as 400 mg (2 x 200 mg tablet (R))

2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Provision of informed consent prior to any study-specific procedures
  • Healthy Volunteers, Females should not be of childbearing potential
  • BMI between 18 and 30 kg/m2

You may not qualify if:

  • Clinically significant ECG abnormality suggestive of underlying cardiovascular disease
  • A history or presence of GI, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism and excretion of drugs
  • Known or suspected drug or alcohol abuse or positive DOA test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Manchester, United Kingdom

Location

Study Officials

  • Mark Layton

    AstraZeneca R&D, Alderley Park, UK

    STUDY DIRECTOR

  • Simon Constable

    ICON Development Solutions, Manchester, UK

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 22, 2009

First Posted

May 27, 2009

Study Start

May 1, 2009

Study Completion

July 1, 2009

Last Updated

July 23, 2009

Record last verified: 2009-07

Locations

GB(1)