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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01247103
Recruitment Status : Withdrawn
First Posted : November 24, 2010
Last Update Posted : December 1, 2010
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: AZD4316 Other: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : December 2010
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : June 2011

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)

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

Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: from screening period to follow-up ]
  2. Assesment of vital signs (blood pressure, pulse and temperature) [ Time Frame: from screening period to follow-up ]
    Frequent assessments will be made for each subject from the screening period to follow up

  3. Assessment of laboratory variables and physical examinations [ Time Frame: from screening period to follow-up ]
    Frequent assessments will be made for each subject from the screening period to follow up

  4. Assessment of Electrocardiogram (ECG) variables [ Time Frame: from screening period to follow-up ]
    Frequent assessments will be made for each subject from the screening period to follow up

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01247103

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United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
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Study Director: Dr Dereck Tait Arrow Therapeutics
Principal Investigator: Dr Darren Wilbraham Quintiles, Inc.
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Responsible Party: Medical Science Director, Arrow Therapeutics Identifier: NCT01247103    
Other Study ID Numbers: D3340C00002
First Posted: November 24, 2010    Key Record Dates
Last Update Posted: December 1, 2010
Last Verified: November 2010
Keywords provided by AstraZeneca:
healthy volunteers