A Study to Assess the Safety, Tolerability and Pharmacokinetics After Single Ascending Intravenous Doses of AZD2927 in Healthy Male Volunteers

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01264250

Enrollment

Registered

2010-12-21

Start date

2011-01-31

Completion date

2011-05-31

Last updated

2011-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Safety, Tolerability, pharmacokinetics, drug metabolism

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.

Interventions

DRUGAZD2927

Single dose of AZD2927

DRUGPlacebo

Single dose of placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of AZD2927, at follow up	Monitoring of Adverse events, Electrocardiograms, vital signs and safety lab at follow up.
Safety and tolerability of AZD2927, day 1	Monitoring of Adverse events, Electrocardiograms, vital signs, safety lab and ophtalmologic variables on day 1.
Safety and tolerability of AZD2927, day 2	Monitoring of Adverse events, Electrocardiograms, vital signs and safety lab on day 2.
Safety and tolerability of AZD2927, day 3	Monitoring of Adverse events, Electrocardiograms, vital signs, and safety lab on day 3.
Safety and tolerability of AZD2927, at screening	Monitoring of Adverse events, Electrocardiograms, vital signs, safety lab and ophtalmologic variables at screening

Secondary

Measure	Time frame
Pharmakokinetic for AZD2927 measured by Cmax, tmax, AUC, t1/2, CL and Vss, day 2	Pharmacokinetic sampling will be performed day 2
Pharmakokinetic for AZD2927 measured by Cmax, tmax, AUC, t1/2, CL and Vss, day 3	Pharmacokinetic sampling will be performed day 3
Pharmakokinetic for AZD2927 measured by Cmax, tmax, AUC, t1/2, CL and Vss, day 1	Pharmacokinetic sampling will be performed day 1

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026