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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: AZD2820; Drug: Placebo

• Registration Number: NCT01332214
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-06
• Study First Submitted QC: 2011-04-07
• Study First Posted: 2011-04-11
• Study Start: 2011-05
• Status Verified: 2011-11
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Last Update Submitted: 2011-11-18
• Last Update Posted: 2011-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AZD2820	AZD2820	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Safety variables ( Adverse events, Vital signs, ECG, EEG, Regiscan, Safety labs.)	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇬🇧 London, United Kingdom