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

NCT ID: NCT01247103

Last Updated: 2010-12-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2011-06-30

Brief 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

Keywords

healthy volunteers; safety; tolerability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Part A: single ascending dose

AZD4316: single oral dose, with 1 group with/without food

Group Type: PLACEBO_COMPARATOR

AZD4316

Intervention Type: DRUG

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)

Placebo

Intervention Type: OTHER

Placebo to match AZD4316

Part B: multiple ascending dose

AZD4316: multiple oral doses

Group Type: PLACEBO_COMPARATOR

AZD4316

Intervention Type: DRUG

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.

Placebo

Intervention Type: OTHER

Placebo to match AZD4316

Interventions

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)

Intervention Type: 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.

Intervention Type: DRUG

Placebo

Placebo to match AZD4316

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Arrow Therapeutics

Principal Investigators

Dr Dereck Tait

Role: STUDY_DIRECTOR

Arrow Therapeutics

Dr Darren Wilbraham

Role: PRINCIPAL_INVESTIGATOR

Quintiles, Inc.

Locations

Research Site

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

D3340C00002

Identifier Type: -

Identifier Source: org_study_id