To Assess the Safety, Tolerability and Pharmacokinetics of AZD2820 After Single Ascending Doses - Full Text View

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: AZD2820 Drug: Placebo	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Basic Science
Official 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Enrollment:	90
Study Start Date:	May 2011
Study Completion Date:	November 2011
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: AZD2820	Drug: AZD2820 Subcutaneous Injection in abdomen or Thigh
Placebo Comparator: Placebo	Drug: Placebo Subcutaneous Injection in abdomen or Thigh

Eligibility

Ages Eligible for Study:	20 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01332214

Locations

United Kingdom
Research Site
London, United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

Study Chair:	Mirjana Kujacic, PhD	AstraZeneca
Principal Investigator:	Prof J Ritter BM BCh, MRCP, FRCP	Quintiles
Study Director:	Mark Berner Hansen, PhD	AstraZeneca

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01332214 History of Changes
Other Study ID Numbers:	D3870C00001
Study First Received:	April 6, 2011
Last Updated:	November 18, 2011
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:

Phase 1
healthy male volunteers
dose escalation
pharmacokinetics

Single Ascending Dose
AZD2820 Cmax
tmax
t1/2λz

ClinicalTrials.gov processed this record on May 16, 2013