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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01264250
First received: December 7, 2010
Last updated: May 23, 2011
Last verified: May 2011

December 7, 2010
May 23, 2011
January 2011
May 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01264250 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study to Assess the Safety, Tolerability and Pharmacokinetics After Single Ascending Intravenous Doses of AZD2927 in Healthy Male Volunteers
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Healthy
  • Drug: AZD2927
    Single dose of AZD2927
  • Drug: Placebo
    Single dose of placebo
  • Experimental: 1
    Intervention: Drug: AZD2927
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
May 2011
May 2011   (final data collection date for primary outcome measure)

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
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01264250
D4120C00001
No
MSD, AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Wolfgang Kühn, MD Quintiles AB
Study Director: Helen Lunde, MD AstraZeneca AB
Principal Investigator: Mirjana Kujacic, MD AstraZeneca AB
AstraZeneca
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP