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

NCT00688714 | Completed Phase 1

• 1 other identifier: D1700C00001
• Study Type: interventional
• Target: 49
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Antiplatelet Effect

Keywords

Antiplatelet

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

Study Arms (2)

1

EXPERIMENTAL

Drug: AZD6482

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AZD6482 DRUG

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

1

Placebo DRUG

2

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

MeSH Terms

Interventions

2-(1-(7-methyl-2-morpholin-4-yl-4-oxo-4H-pyrido(1,2-a)pyrimidin-9-yl)ethylamino)benzoic acid

Study Officials

• Marianne Hartford, MD

  AstraZeneca R&D, Clinical Pharmacology Unit, Sahlgrenska University Hospital, Göteborg, Sweden

  PRINCIPAL INVESTIGATOR

• Brian Bryzinski, MD

  AstraZeneca Wilmington, DE United States

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 30, 2008
• First Posted: June 3, 2008
• Study Start: January 1, 2008
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: June 3, 2008

Record last verified: 2008-05