A Study to Assess the Safety, Tolerability and Pharmacokinetics After Single Ascending Intravenous Doses of AZD2927 in Healthy Male Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: AZD2927; Drug: Placebo

• Registration Number: NCT01264250
• Lead Sponsor: AstraZeneca

Brief Summary

In this early phase study, healthy male volunteers will be randomly assigned to one dose of either AZD2927 or placebo. The objective will be to assess the Safety,Tolerability and Pharmacokinetics of AZD2927.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-12-07
• Study First Submitted QC: 2010-12-20
• Study First Posted: 2010-12-21
• Study Start: 2011-01
• Status Verified: 2011-05
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Last Update Submitted: 2011-05-23
• Last Update Posted: 2011-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

Inclusion Criteria

• Provision of signed and dated, written informed consent prior to any study specific procedures
• Healthy male subjects aged 18 to 45 years inclusive with suitable veins for cannulation or repeated venepuncture
• Male subjects should be willing to use barrier contraception ie, condoms, from the day of dosing until 3 months after dosing with the Investigational Product (IP)
• Have a body mass index (BMI) between 19.0 and 30.0 kg/m2 and weight of at least 50.0 kg and no more than 100.0 kg

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
• History or presence of gastrointestinal, mental, cardiac, hepatic or renal disorder, or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
• Abnormal vital signs, after 10 minutes supine rest
• Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the administration of IP
• Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AZD2927	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of AZD2927, day 3	Monitoring of Adverse events, Electrocardiograms, vital signs, and safety lab on day 3.
Safety and tolerability of AZD2927, at screening	Monitoring of Adverse events, Electrocardiograms, vital signs, safety lab and ophtalmologic variables at screening
Safety and tolerability of AZD2927, day 1	Monitoring of Adverse events, Electrocardiograms, vital signs, safety lab and ophtalmologic variables on day 1.
Safety and tolerability of AZD2927, day 2	Monitoring of Adverse events, Electrocardiograms, vital signs and safety lab on day 2.
Safety and tolerability of AZD2927, at follow up	Monitoring of Adverse events, Electrocardiograms, vital signs and safety lab at follow up.

Secondary Outcome Measures

Name	Time	Method
Pharmakokinetic for AZD2927 measured by Cmax, tmax, AUC, t1/2, CL and Vss, day 1	Pharmacokinetic sampling will be performed day 1
Pharmakokinetic for AZD2927 measured by Cmax, tmax, AUC, t1/2, CL and Vss, day 2	Pharmacokinetic sampling will be performed day 2
Pharmakokinetic for AZD2927 measured by Cmax, tmax, AUC, t1/2, CL and Vss, day 3	Pharmacokinetic sampling will be performed day 3

Trial Locations

Locations (1)

Research Site; 🇸🇪 Uppsala, Sweden