Study to Investigate Safety and Tolerability of a Single Dose of AZD6482

A Randomised, Double-Blind, Placebo-Controlled Phase I Study to Assess the Tolerability, Safety, Pharmacokinetic, and Pharmacodynamic Properties of AZD6482, Alone and co-Administered With ASA, After Single Ascending Intravenous Doses to Healthy Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00688714

Enrollment

Registered

2008-06-03

Start date

2008-01-31

Completion date

2008-05-31

Last updated

2008-06-03

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

Conditions

Antiplatelet Effect

Keywords

Antiplatelet

Brief summary

AZD6482 is a new drug substance aiming to prevent blood clots which may arise in atherosclerotic blood vessels and cause myocardial infarction or stroke. This is the first study with AZD6482 in humans. The primary aim for this study is to evaluate the safety and tolerability of AZD6482 in healthy human volunteers. How the substance is metabolised and eliminated from the body will also be studied. This will be done by comparing the effect of single ascending doses of AZD6482 to placebo (inactive substance).

Interventions

DRUGPlacebo

DRUGAZD6482

0,9-364,5 mg administrated through intravenous infusion over 3 hours

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* BMI between 19.0 and 30.0 kg/m2, inclusive and body weight between 50.0 and 100.0 kg, inclusive * Provision of written informed consent

Exclusion criteria

* Personal or family history of bleeding disorders, or reasonable suspicion of vascular malformations, including aneurysms. * Acute illness, surgical procedure or trauma from 2 weeks before pre-entry visit until administration of investigational product or clinically significant abnormalities in clinical chemistry, haematology, faeces, urinalysis or supine BP or pulse * Known impaired glucose intolerance or known or suspected Gilbert´s syndrome

Design outcomes

Primary

Measure	Time frame
General safety and tolerability including adverse events, physical examination, vital signs, ECG parameters and laboratory variables	Prior to dose, repeatedly during 24 hrs after dose and at the follow-up visit 7-10 days after.

Secondary

Measure	Time frame
Capillary Bleeding Time, Insulin and glucose homeostasis (HoMa-Index)	Prior to dose, repeatedly during 24 hrs after dose and at the follow-up visit 7-10 days after.
Pharmacokinetics and inhibition of platelet aggregation	Prior to dose and repeatedly during 24 hrs after dose.

Outcome results

None listed

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