Clinical trial NCT01264250: A Study to Assess the Safety, Tolerability and Pharmacokinetics After Single Ascending Intravenous Doses of AZD2927 in Healthy Male Volunteers
Official title: A Phase I, Single-centre, Single-blind, Randomised, Placebo-controlled, Single-dose Study to Assess the Safety, Tolerability and Pharmacokinetics After Single Ascending Intravenous Doses of AZD2927 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety
Tolerability
pharmacokinetics
drug metabolism
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-12-21
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In this early phase study, healthy male volunteers will be randomly assigned to one dose of either AZD2927 or placebo. The objective will be to assess the Safety,Tolerability and Pharmacokinetics of AZD2927.


Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study specific procedures
* Healthy male subjects aged 18 to 45 years inclusive 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 (IP)
* Have a body mass index (BMI) between 19.0 and 30.0 kg/m2 and weight of at least 50.0 kg and no more than 100.0 kg

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, mental, cardiac, hepatic or renal disorder, or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
* Abnormal vital signs, after 10 minutes supine rest
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the administration of IP
* Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator

Primary outcomes:
measure: Safety and tolerability of AZD2927, at screening
timeFrame: Monitoring of Adverse events, Electrocardiograms, vital signs, safety lab and ophtalmologic variables at screening
measure: Safety and tolerability of AZD2927, day 1
timeFrame: Monitoring of Adverse events, Electrocardiograms, vital signs, safety lab and ophtalmologic variables on day 1.
measure: Safety and tolerability of AZD2927, day 2
timeFrame: Monitoring of Adverse events, Electrocardiograms, vital signs and safety lab on day 2.
measure: Safety and tolerability of AZD2927, day 3
timeFrame: Monitoring of Adverse events, Electrocardiograms, vital signs, and safety lab on day 3.
measure: Safety and tolerability of AZD2927, at follow up
timeFrame: Monitoring of Adverse events, Electrocardiograms, vital signs and safety lab at follow up.
Secondary outcomes:
measure: Pharmakokinetic for AZD2927 measured by Cmax, tmax, AUC, t1/2, CL and Vss, day 1
timeFrame: Pharmacokinetic sampling will be performed day 1
measure: Pharmakokinetic for AZD2927 measured by Cmax, tmax, AUC, t1/2, CL and Vss, day 2
timeFrame: Pharmacokinetic sampling will be performed day 2
measure: Pharmakokinetic for AZD2927 measured by Cmax, tmax, AUC, t1/2, CL and Vss, day 3
timeFrame: Pharmacokinetic sampling will be performed day 3
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Research Site
Study officials:
affiliation: Quintiles AB
name: Wolfgang Kühn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Helen Lunde, MD
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Mirjana Kujacic, MD
role: PRINCIPAL_INVESTIGATOR
References: