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

AstraZeneca

Status and phase: Withdrawn; Phase 1

Conditions: Healthy Volunteers

Treatments: Other: Placebo; Drug: AZD4316

Study type: Interventional

Funder types: Industry

Identifiers

NCT01247103

D3340C00002

Details and patient eligibility

About

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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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128 participants in 2 patient groups, including a placebo group

Part A: single ascending dose

Placebo Comparator group

Description:

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

Treatment:

Drug: AZD4316

Drug: AZD4316

Other: Placebo

Part B: multiple ascending dose

Placebo Comparator group

Description:

AZD4316: multiple oral doses

Treatment:

Drug: AZD4316

Drug: AZD4316

Other: Placebo