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A Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Multiple Ascending Doses of AZD5069 in Healthy Volunteers

NCT01051505 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2015-06-25

No results posted yet for this study

Summary

The purpose of this study is to explore the safety and tolerability of AZD5069 at steady-state, following twice a day oral dosing in healthy subjects.

AZD5069 is being developed by AstraZeneca and this study is being carried out on behalf of the sponsor by Quintiles Drug Research Unit at Guy's Hospital, London. This is the second time that AZD5069 will be administered to humans in clinical trials. We are conducting this study to determine whether AZD5069 is safe and well tolerated by healthy males and females at different dose levels over an 8-day dosing period. We will also be studying how quickly AZD5069 is absorbed into and cleared by the body. It is planned that there will be up to 3 dose groups in the study and each group will consist of up to 12 volunteers, with 9 receiving the active drug and 3 receiving placebo. The study involves 3 visits over approximately 8 weeks, and will include 1 residential visit lasting 10 nights and a follow up.

Conditions

  • Healthy

Interventions

DRUG

AZD5069

oral suspension dose of AZD5069. Multiple doses will be given once daily on day 1 and day 8 and twice daily on days 2 to 7

DRUG

Placebo

oral suspension dose of matched placebo. Multiple doses will be given once daily on day 1 and day 8 and twice daily on days 2 to 7

Sponsors & Collaborators

Principal Investigators

  • Darren Wilbraham, MBBS, DCPSA · Quintiles, Inc.

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • United Kingdom

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01051505 on ClinicalTrials.gov