AZD5985 Single Ascending Dose Study

Phase 1

Terminated

• Conditions: Healthy
• Interventions: Drug: AZD5985; Drug: Placebo

• Registration Number: NCT00967356
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-26
• Study First Submitted QC: 2009-08-26
• Study First Posted: 2009-08-27
• Status Verified: 2009-11
• Study Completion: 2009-11
• Last Update Submitted: 2009-11-11
• Last Update Posted: 2009-11-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	AZD5985	AZD5985
B	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab)	Frequent sampling occasions during study days

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic variables	Frequent sampling occasions during study days

Trial Locations

Locations (1)

Research Site; 🇸🇪 Goteborg, Sweden