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

AstraZeneca1 site in 1 country90 target enrollmentMay 2011

ConditionsHealthy

InterventionsAZD2820 Placebo

DrugsAZD2820 Placebo

Overview

Phase: Phase 1
Intervention: AZD2820
Conditions: Healthy
Sponsor: AstraZeneca
Enrollment: 90
Locations: 1
Primary Endpoint: Safety variables ( Adverse events, Vital signs, ECG, EEG, Regiscan, Safety labs.)
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

May 2011

End Date

November 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

AZD2820

Intervention: AZD2820

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

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

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.(Blood samples will be taken multiple times from the morning day 1 before dose until day 2)