Relative Bioavailability Study in Healthy Male Subjects for ZD4054 (Zibotentan) Immediate Release Tablets.

NCT00713791 | Completed Phase 1

• 2 other identifiers: D4320C00029ZD4054IL0029
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to see how different formulations of ZD4054 (Zibotentan) are absorbed by the body. As for all clinical trials, safety and tolerability of the drug will be evaluated.

Conditions

Healthy

Keywords

Healthy Volunteers; ZD4054

Outcome Measures

Primary Outcomes (1)

• characterise and compare the plasma concentration-time profiles for ZD4054 (Zibotentan) when administered as reference oral solution formulation and as 5 solid oral formulations.

  00.50mins, 01.00, 01.15, 01.30, 01.45, 02.00, 02.30, 03.00, 04.00, 06.00, 08.00, 12.00, 24.00, 36.00, 48.00, 72.00, 96.00hrs

Secondary Outcomes (2)

• characterise and compare pharmacokinetic parameters for ZD4054 (Zibotentan) when administered as an oral solution and as 5 solid oral formulations and to assure the safety of all healthy volunteers by assessment of vital signs, ECG, Labs, and AEs

  00.05, 00.10, 00.15, 00.20, 00.30, 00.40, 00.50mins, 01.00, 01.15, 01.30, 01.45, 02.00, 02.30, 03.00, 04.00, 06.00, 08.00, 12.00, 24.00, 36.00, 48.00, 72.00, 96.00hrs

• To assure the safety of all subjects by assessment of vital signs, ECG, clinical chemistry, haematology, urinalysis and adverse events.

  From time of Consent to Last Visit

Study Arms (1)

1

EXPERIMENTAL

There are 5 variations of the ZD4054 (Zibotentan) 10mg tablet - A, B, C, D, and E. A minimum washout period of 1 week will occur between each treatment period.

Drug: ZD4054

Interventions

ZD4054 DRUG

Treatment period 1: 10mg oral solution

Also known as: Zibotentan

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Philadelphia, Pennsylvania, United States

Location

MeSH Terms

Interventions

ZD4054

Study Officials

• Sylvan Hurewitz

  AZ Clinical Pharmacology Unit, Philadelphia, USA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• 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: August 1, 2008
• Last Updated: November 15, 2010

Record last verified: 2010-11

Locations

US (1)