Antiplatelet EffectPhase 1NCT00688714
Study to Investigate Safety and Tolerability of a Single Dose of AZD6482
A Phase 1 study testing AZD6482 in people with Antiplatelet Effect, run by AstraZeneca.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Antiplatelet Effect
- What is being tested?
- AZD6482
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to May 2008
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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
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
- Being tested
- AZD6482, Placebo
- Keywords
- Antiplatelet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD6482Drug
0,9-364,5 mg administrated through intravenous infusion over 3 hours
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: AZD6482 |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
General safety and tolerability including adverse events, physical examination, vital signs, ECG parameters and laboratory variables
Measured: 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)
Measured: 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
Measured: Prior to dose and repeatedly during 24 hrs after dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study startJan 2008
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antiplatelet EffectStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Marianne Hartford, MD, Principal investigator, AstraZeneca R&D, Clinical Pharmacology Unit, Sahlgrenska University Hospital, Göteborg, SwedenBrian Bryzinski, MD, Study chair, AstraZeneca Wilmington, DE United States
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00688714
- Sponsor's protocol ID
- D1700C00001
- Status last verified
- May 2008
- First submitted
- 30 May 2008
- Last updated
- 3 Jun 2008
- Results posted
- No
- Data monitoring committee
- No