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

NCT01247103 | Withdrawn Phase 1

• 1 other identifier: D3340C00002
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• 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

Study Arms (2)

Part A: single ascending dose

PLACEBO COMPARATOR

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

Drug: AZD4316; Other: Placebo

Part B: multiple ascending dose

PLACEBO COMPARATOR

AZD4316: multiple oral doses

Drug: AZD4316; Other: Placebo

Interventions

AZD4316 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)

Part A: single ascending dose

Placebo OTHER

Placebo to match AZD4316

Part A: single ascending dose; Part B: multiple ascending dose

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

London, United Kingdom

Location

Study Officials

• Dr Dereck Tait

  Arrow Therapeutics

  STUDY DIRECTOR

• Dr Darren Wilbraham

  Quintiles, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 16, 2010
• First Posted: November 24, 2010
• Study Start: December 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: December 1, 2010

Record last verified: 2010-11

Locations

GB (1)