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Completed

NCT Number: NCT01332214

To Assess the Safety, Tolerability and Pharmacokinetics of AZD2820 After Single Ascending Doses

This is a randomised, single-blind, placebo-controlled Phase I study to investigate the safety, tolerability and pharmacokinetics after administration of single doses of AZD2820 to healthy male subjects.

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Key information

Conditions

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

London, United Kingdom

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 ≥20 - ≤45 years 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.
  • Have a body mass index (BMI) between≥ 18 and ≤30 kg/m2 and weigh at least 50 kg and no more than 100 kg.
  • Provision of signed, written and dated informed consent for genetic research. If a subject declines to participate in the genetic component of the study, there will be no penalty or loss of benefit to the subject. The subject will not be excluded from other aspects of the study described in this Clinical Study Protocol, so long as they consent.

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, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
  • A history of erectile dysfunction or anatomic abnormality of the penis (eg, cavernosal fibrosis, Peyronie's disease, or plaques) which interferes with normal erectile function
  • Predisposition or history of priapism (eg, sickle cell anemia or trait).
  • Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product

Treatment and study plan

AZD2820

Drug

Subcutaneous Injection in abdomen or Thigh

Placebo

Drug

Subcutaneous Injection in abdomen or Thigh

Primary outcomes

  1. Safety variables ( Adverse events, Vital signs, ECG, EEG, Regiscan, Safety labs.)

    Time frame: Assessments performed multilpe times from the morning day 1 before dose until day 3. And then once at the follow up after 14-18 days

Secondary outcomes

  1. To evaluate the pharmacokinetics of AZD2820 and assess the dose proportionality of the pharmacokinetics following single ascending doses of AZD2820 by assessment Cmax, tmax, t1/2 , AUC, CL/F, Ae and CLR.

    Time frame: Blood samples will be taken multiple times from the morning day 1 before dose until day 2

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Randomised, Single-blind, Placebo-controlled Single-centre Phase I Study in Healthy Male Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of AZD2820 After Single Ascending Doses

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 11, 2011
Registry last updated
Nov 21, 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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