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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01247103
First received: November 16, 2010
Last updated: November 30, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
Drug: AZD4316
Other: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: from screening period to follow-up ] [ Designated as safety issue: No ]
  • Assesment of vital signs (blood pressure, pulse and temperature) [ Time Frame: from screening period to follow-up ] [ Designated as safety issue: No ]
    Frequent assessments will be made for each subject from the screening period to follow up

  • Assessment of laboratory variables and physical examinations [ Time Frame: from screening period to follow-up ] [ Designated as safety issue: No ]
    Frequent assessments will be made for each subject from the screening period to follow up

  • Assessment of Electrocardiogram (ECG) variables [ Time Frame: from screening period to follow-up ] [ Designated as safety issue: No ]
    Frequent assessments will be made for each subject from the screening period to follow up


Secondary Outcome Measures:
  • Pharmacokinetic variables of AZD4316 by assessment of drug concentrations in plasma and urine [ Time Frame: Serial blood samples and urine collection for PK evaluation throughout the period of admission and up to the time of the follow-up visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 128
Study Start Date: December 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Other: Placebo
Placebo to match AZD4316
Placebo Comparator: Part B: multiple ascending dose
AZD4316: multiple oral doses
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01247103

Locations
United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Dr Dereck Tait Arrow Therapeutics
Principal Investigator: Dr Darren Wilbraham Quintiles
  More Information

No publications provided

Responsible Party: Medical Science Director, Arrow Therapeutics
ClinicalTrials.gov Identifier: NCT01247103     History of Changes
Other Study ID Numbers: D3340C00002
Study First Received: November 16, 2010
Last Updated: November 30, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
healthy volunteers
safety
tolerability

ClinicalTrials.gov processed this record on September 16, 2014