AZD5985 Single Ascending Dose Study

AstraZeneca

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: AZD5985

Study type: Interventional

Funder types: Industry

Identifiers

NCT00967356

D2300C00002

Details and patient eligibility

About

The aims of this study are to assess the safety, tolerability and pharmacokinetics of single ascending oral doses of AZD5985 in healthy male subjects.

Enrollment: 72 estimated patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provision of signed, written and dated informed consent prior to any study specific procedure
• Healthy male subjects aged 18 to 45 years (inclusive)
• Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
• Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for >6 months prior to study start

Exclusion criteria

• History or presence of any clinically significant disease or disorder in the opinion of the investigator
• Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator
• Participation in another investigational drug study within 3 months before Visit 2 or participation in a methodological study (no drug) 1 month prior to Visit 2

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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72 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

AZD5985

Treatment:

Drug: AZD5985

B

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo