NCT00713336

Brief Summary

This Study compares two ZD4054 (Zibotentan) doses (10mg and 30mg) with a placebo and a positive control to look at ZD4054 (Zibotentan)'s effect on the ECG of Healthy Volunteer

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jun 2008

Typical duration 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

June 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 9, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 11, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

September 28, 2010

Status Verified

September 1, 2010

First QC Date

July 9, 2008

Last Update Submit

September 27, 2010

Conditions

Healthy

Keywords

ZD4054Healthy VolunteersQT interval

Outcome Measures

Primary Outcomes (1)

  • to assess the maximum of the mean changes in time-matched QTcX (study specific correction) intervals after ZD4054 (Zibotentan) administration (10mg and 30mg) compared to placebo

    Pre-dose, 0.5hr, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h

Secondary Outcomes (3)

  • assess the maximum of the mean changes in time-matched QT, QTcB (Bazett's correction), QTcF (Fridericia's correction) and QTcI (subject specific correction) intervals after ZD4054 (Zibotentan) administration (10mg and 30mg) compared to placebo

    Pre-dose, 0.5hr, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h

  • assess the maximum of mean changes in time-matched QTcX, QT, QTcB, QTcF and QTcI intervals after moxifloxacin administration compared to placebo.

    Pre-dose, 0.5hr, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h

  • further assess the safety and tolerability of ZD4054 (Zibotentan) by assessment of adverse events (AEs), laboratory variables and vital signs.

    From time of Consent to Last Follow-up Visit

Study Arms (4)

1

EXPERIMENTAL

ZD4054 + Moxifloxacin placebo

Drug: ZD4054Drug: Moxifloxacin placebo

2

ACTIVE COMPARATOR

ZD4054 placebo + Moxifloxacin

Drug: ZD4054Drug: MoxifloxacinDrug: ZD4054 Placebo

3

EXPERIMENTAL

ZD4054 + ZD4054 placebo + Moxifloxacin placebo

Drug: ZD4054Drug: Moxifloxacin placeboDrug: ZD4054 Placebo

4

PLACEBO COMPARATOR

ZD4054 Placebo + Moxifloxacin placebo

Drug: ZD4054Drug: ZD4054 PlaceboDrug: Moxifloxacin placebo

Interventions

ZD4054DRUG

ZD4054 10mg Tablet

Also known as: Zibotentan
1234
MoxifloxacinDRUG

400 mg capsule

Also known as: AVELOX
2
ZD4054 PlaceboDRUG

3 tablets

24
Moxifloxacin placeboDRUG

1 capsule

134

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Non Smoker
  • Normal resting 12-lead ECG with normal QTc interval (\<450 msec)
  • Negative screens for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV) at screening

You may not qualify if:

  • Receipt of another new chemical entity in the 4 months before dosing in this study; participation in another study and participation in a non-invasive methodology study in which no drugs were given within 30 days before dosing in this study
  • Risk (in the investigator's opinion) of transmitting, through blood or other body fluids, the agents responsible for acquired immune deficiency syndrome (AIDS), hepatitis B or hepatitis C
  • Judgement by the investigator, that the healthy volunteer should not participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Macclesfield, United Kingdom

Location

MeSH Terms

Interventions

ZD4054Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Raj Chetty, MD

    Clinical Pharmacology UnitAlderley ParkAstraZenecaMacclesfieldSK10 4TG

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 9, 2008

First Posted

July 11, 2008

Study Start

June 1, 2008

Study Completion

November 1, 2008

Last Updated

September 28, 2010

Record last verified: 2010-09

Locations

GB(1)