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Assessment of the Safety and Pharmacokinetics of Single and Multiple Oral Doses of AZD4316 in Healthy Subjects

NCT01247103 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2010-12-01

No results posted yet for this study

Summary

The purpose of the study is to assess the safety, tolerability and pharmacokinetics of AZD4316 following oral administration of single and multiple doses to healthy volunteers.

Conditions

  • Healthy Volunteers

Interventions

DRUG

AZD4316

Single oral doses of AZD4316 suspension in the fasted state. In one group in Part A, subjects will receive a second dose of AZD4316 in the fed state (within 30 min after receiving a high fat breakfast)

DRUG

AZD4316

Multiple oral doses of AZD4316 suspension. It's planned that doses will be administered in the fasted state, however, if in Part A it's shown that food increases absorption of AZD4316, then doses will be administered after a meal.

OTHER

Placebo

Placebo to match AZD4316

Sponsors & Collaborators

Principal Investigators

  • Dr Dereck Tait · Arrow Therapeutics

  • Dr Darren Wilbraham · Quintiles, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • United Kingdom

Study Locations

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Entities

Companies

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 NCT01247103 on ClinicalTrials.gov