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

NCT01332214 | Completed Phase 1

• 1 other identifier: D3870C00001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Phase 1; healthy male volunteers; dose escalation; pharmacokinetics; Single Ascending Dose; AZD2820 Cmax; tmax; t1/2λz

Outcome Measures

Primary Outcomes (1)

• 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 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.

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

Study Arms (2)

AZD2820

EXPERIMENTAL

Drug: AZD2820

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AZD2820 DRUG

Subcutaneous Injection in abdomen or Thigh

AZD2820

Placebo DRUG

Subcutaneous Injection in abdomen or Thigh

Placebo

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

London, United Kingdom

Location

Study Officials

• Mirjana Kujacic, PhD

  AstraZeneca

  STUDY CHAIR

• Prof J Ritter BM BCh, MRCP, FRCP

  Quintiles, Inc.

  PRINCIPAL INVESTIGATOR

• Mark Berner Hansen, PhD

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2011
• First Posted: April 11, 2011
• Study Start: May 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: November 21, 2011

Record last verified: 2011-11

Locations

GB (1)