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

A Phase 1, Single-centre Randomised, Double-Blind, Placebo-Controlled, Single and Multiple Dose, Parallel-group Study to Determine the Safety, Tolerability, and Pharmacokinetics of AZD4316 in Healthy Volunteers

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.

Study Overview

• Status: Withdrawn
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: AZD4316; Drug: AZD4316; Other: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 128
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy male and female subjects aged 18 to 50 years with suitable veins for cannulation or repeated venepuncture.
• Female subjects must not be pregnant, must not be lactating and must be of non-child-bearing potential (i.e. they must be post-menopausal or surgically sterile)
• Male subjects should be willing to use barrier contraception i.e. condoms and spermicide, from the day of dosing until at least 3 months after dosing with the investigational product
• Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.
• Subjects who are healthy as determined by pre study medical history, physical examination, 12-Lead ECG

Exclusion Criteria:

• History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
• Any clinically important abnormalities in rhythm, conduction or morphology of the resting ECG, including changes that may interfere with the interpretation of QTcF interval changes.
• Current smokers, those who have smoked or used nicotine products within the previous three months.
• History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD4316.
• Judgment by the investigator that the subject should not participate in the study if they have any ongoing or recent (ie, during the screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions and requirements.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Part A: single ascending dose; AZD4316: single oral dose, with 1 group with/without food	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
Placebo Comparator: Part B: multiple ascending dose; AZD4316: multiple oral doses	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events		from screening period to follow-up
Assesment of vital signs (blood pressure, pulse and temperature)	Frequent assessments will be made for each subject from the screening period to follow up	from screening period to follow-up
Assessment of laboratory variables and physical examinations	Frequent assessments will be made for each subject from the screening period to follow up	from screening period to follow-up
Assessment of Electrocardiogram (ECG) variables	Frequent assessments will be made for each subject from the screening period to follow up	from screening period to follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetic variables of AZD4316 by assessment of drug concentrations in plasma and urine	Serial blood samples and urine collection for PK evaluation throughout the period of admission and up to the time of the follow-up visit

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Dr Dereck Tait, Arrow Therapeutics; Principal Investigator: Dr Darren Wilbraham, Quintiles, Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Anticipated): June 1, 2011
• Study Completion (Anticipated): June 1, 2011

Study Registration Dates

• First Submitted: November 16, 2010
• First Submitted That Met QC Criteria: November 23, 2010
• First Posted (Estimate): November 24, 2010

Study Record Updates

• Last Update Posted (Estimate): December 1, 2010
• Last Update Submitted That Met QC Criteria: November 30, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: tolerability; safety; healthy volunteers
• Other Study ID Numbers: D3340C00002