Clinical trial NCT01247103: Assessment of the Safety and Pharmacokinetics of Single and Multiple Oral Doses of AZD4316 in Healthy Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: healthy volunteers
safety
tolerability
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-11-24
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: from screening period to follow-up
measure: Assesment of vital signs (blood pressure, pulse and temperature)
timeFrame: from screening period to follow-up
measure: Assessment of laboratory variables and physical examinations
timeFrame: from screening period to follow-up
measure: Assessment of Electrocardiogram (ECG) variables
timeFrame: from screening period to follow-up
Secondary outcomes:
measure: Pharmacokinetic variables of AZD4316 by assessment of drug concentrations in plasma and urine
timeFrame: Serial blood samples and urine collection for PK evaluation throughout the period of admission and up to the time of the follow-up visit
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Arrow Therapeutics
name: Dr Dereck Tait
role: STUDY_DIRECTOR
affiliation: Quintiles, Inc.
name: Dr Darren Wilbraham
role: PRINCIPAL_INVESTIGATOR
References: