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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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Principal Investigator: Mirjana Kujacic, MD AstraZeneca
  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 November 20, 2014