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

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: AZD2927 Drug: Placebo	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science
Official Title:	A Phase I, Single-centre, Single-blind, Randomised, Placebo-controlled, Single-dose Study to Assess the Safety, Tolerability and Pharmacokinetics After Single Ascending Intravenous Doses of AZD2927 in Healthy Male Subjects

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Safety and tolerability of AZD2927, at screening [ Time Frame: Monitoring of Adverse events, Electrocardiograms, vital signs, safety lab and ophtalmologic variables at screening ] [ Designated as safety issue: Yes ]
Safety and tolerability of AZD2927, day 1 [ Time Frame: Monitoring of Adverse events, Electrocardiograms, vital signs, safety lab and ophtalmologic variables on day 1. ] [ Designated as safety issue: Yes ]
Safety and tolerability of AZD2927, day 2 [ Time Frame: Monitoring of Adverse events, Electrocardiograms, vital signs and safety lab on day 2. ] [ Designated as safety issue: Yes ]
Safety and tolerability of AZD2927, day 3 [ Time Frame: Monitoring of Adverse events, Electrocardiograms, vital signs, and safety lab on day 3. ] [ Designated as safety issue: Yes ]
Safety and tolerability of AZD2927, at follow up [ Time Frame: Monitoring of Adverse events, Electrocardiograms, vital signs and safety lab at follow up. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmakokinetic for AZD2927 measured by Cmax, tmax, AUC, t1/2, CL and Vss, day 1 [ Time Frame: Pharmacokinetic sampling will be performed day 1 ] [ Designated as safety issue: No ]
Pharmakokinetic for AZD2927 measured by Cmax, tmax, AUC, t1/2, CL and Vss, day 2 [ Time Frame: Pharmacokinetic sampling will be performed day 2 ] [ Designated as safety issue: No ]
Pharmakokinetic for AZD2927 measured by Cmax, tmax, AUC, t1/2, CL and Vss, day 3 [ Time Frame: Pharmacokinetic sampling will be performed day 3 ] [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	January 2011
Study Completion Date:	May 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: AZD2927 Single dose of AZD2927
Placebo Comparator: 2	Drug: Placebo Single dose of placebo

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01264250

Locations

Sweden
Research Site
Uppsala, Sweden

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	Wolfgang Kühn, MD	Quintiles AB
Study Director:	Helen Lunde, MD	AstraZeneca AB
Principal Investigator:	Mirjana Kujacic, MD	AstraZeneca AB

More Information

No publications provided

Responsible Party:	MSD, AstraZeneca
ClinicalTrials.gov Identifier:	NCT01264250 History of Changes
Other Study ID Numbers:	D4120C00001
Study First Received:	December 7, 2010
Last Updated:	May 23, 2011
Health Authority:	Sweden: Medical Products Agency

Keywords provided by AstraZeneca:

Safety
Tolerability
pharmacokinetics
drug metabolism

ClinicalTrials.gov processed this record on May 22, 2013