NCT00710047

Brief Summary

The purpose of the study is to assess the effect of food on the pharmacokinetics of a 10 mg single oral dose of ZD4054 (Zibotentan)

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-volunteers

Timeline
Completed

Started Jun 2008

Shorter than P25 for phase_1 healthy-volunteers

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

June 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 1, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2008

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

November 15, 2010

Status Verified

November 1, 2010

Enrollment Period

2 months

First QC Date

July 1, 2008

Last Update Submit

November 10, 2010

Conditions

Healthy Volunteers

Keywords

ZD4054ZibotentanHealthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • PK variables

    frequent sampling occasions during study days

Secondary Outcomes (1)

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

    During the whole treatment period

Study Arms (2)

1

EXPERIMENTAL

Fasting state

Drug: ZD4054

2

EXPERIMENTAL

after high-fat breakfast

Drug: ZD4054

Interventions

ZD4054DRUG

one single 10mg dose

Also known as: Zibotentan
12

Eligibility Criteria

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

You may qualify if:

  • BMI between 18 and 30 kg/m2
  • Medical and surgical history and physical examination without any clinically significant findings
  • Able to consume standard FDA specified high-fat breakfast.

You may not qualify if:

  • Definite or suspected personal history or family history of hypersensitivity to drugs that are endothelin antagonists; ie, ambrisentan, artrasentan, sitaxsetan and bosentan
  • Medical diagnosis of migraine with an attack during the 12 months prior to Screening
  • Use of prescription medication within 2 weeks before dosing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Harrow, United Kingdom

Location

MeSH Terms

Interventions

ZD4054

Study Officials

  • Thomas Morris

    AstraZeneca, Medical Science Director

    STUDY DIRECTOR

  • David Wessels

    Parexel

    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

July 1, 2008

First Posted

July 3, 2008

Study Start

June 1, 2008

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

November 15, 2010

Record last verified: 2010-11

Locations

GB(1)