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Completed

NCT Number: NCT01264250

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

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.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Uppsala, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD2927

Drug

Single dose of AZD2927

Placebo

Drug

Single dose of placebo

Primary outcomes

  1. Safety and tolerability of AZD2927, at screening

    Time frame: Monitoring of Adverse events, Electrocardiograms, vital signs, safety lab and ophtalmologic variables at screening

  2. Safety and tolerability of AZD2927, day 1

    Time frame: Monitoring of Adverse events, Electrocardiograms, vital signs, safety lab and ophtalmologic variables on day 1.

  3. Safety and tolerability of AZD2927, day 2

    Time frame: Monitoring of Adverse events, Electrocardiograms, vital signs and safety lab on day 2.

  4. Safety and tolerability of AZD2927, day 3

    Time frame: Monitoring of Adverse events, Electrocardiograms, vital signs, and safety lab on day 3.

  5. Safety and tolerability of AZD2927, at follow up

    Time frame: Monitoring of Adverse events, Electrocardiograms, vital signs and safety lab at follow up.

Secondary outcomes

  1. Pharmakokinetic for AZD2927 measured by Cmax, tmax, AUC, t1/2, CL and Vss, day 1

    Time frame: Pharmacokinetic sampling will be performed day 1

  2. Pharmakokinetic for AZD2927 measured by Cmax, tmax, AUC, t1/2, CL and Vss, day 2

    Time frame: Pharmacokinetic sampling will be performed day 2

  3. Pharmakokinetic for AZD2927 measured by Cmax, tmax, AUC, t1/2, CL and Vss, day 3

    Time frame: Pharmacokinetic sampling will be performed day 3

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Dec 21, 2010
Registry last updated
May 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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