Clinical trial NCT01332214: To Assess the Safety, Tolerability and Pharmacokinetics of AZD2820 After Single Ascending Doses
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Phase 1
healthy male volunteers
dose escalation
pharmacokinetics
Single Ascending Dose
AZD2820 Cmax
tmax
t1/2λz
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-04-11
Enrollment: 90
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Safety variables ( Adverse events, Vital signs, ECG, EEG, Regiscan, Safety labs.)
timeFrame: 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:
measure: 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.
timeFrame: Blood samples will be taken multiple times from the morning day 1 before dose until day 2
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Mirjana Kujacic, PhD
role: STUDY_CHAIR
affiliation: Quintiles, Inc.
name: Prof J Ritter BM BCh, MRCP, FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Mark Berner Hansen, PhD
role: STUDY_DIRECTOR
References: