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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: AZD2820; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Subcutaneous Injection in abdomen or Thigh
Experimental: AZD2820	Drug: AZD2820; Subcutaneous Injection in abdomen or Thigh

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Chair: Mirjana Kujacic, PhD, AstraZeneca; Principal Investigator: Prof J Ritter BM BCh, MRCP, FRCP, Quintiles, Inc.; Study Director: Mark Berner Hansen, PhD, AstraZeneca

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: April 6, 2011
• First Submitted That Met QC Criteria: April 7, 2011
• First Posted (Estimate): April 11, 2011

Study Record Updates

• Last Update Posted (Estimate): November 21, 2011
• Last Update Submitted That Met QC Criteria: November 18, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: pharmacokinetics; Phase 1; t1/2λz; tmax; dose escalation; Single Ascending Dose; healthy male volunteers; AZD2820 Cmax
• Other Study ID Numbers: D3870C00001