Thrombin InhibitionPhase 1NCT01150812
Oral AZD8165 After Single Oral Ascending Doses in Healthy Male Subjects
A Phase 1 study testing AZD8165 in people with Thrombin Inhibition, run by AstraZeneca at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of AZD8165 and the pharmacokinetics of the metabolite AZ12971554 and plasma levels of the prodrug AZD8165 after escalating single oral low doses. 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
- Thrombin Inhibition
- What is being tested?
- AZD8165
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Aug 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Suitable veins for cannulation or repeated venipuncture
- Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and nor more than 100 kg
Who cannot join
- History of any clinically significancy disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study
- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
- Personal or family history of bleeding disorders, or reasonable suspicion of vascular malformations, including aneurysms.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single-center, Single-blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AZD8165 After Single Oral Ascending Doses in Healthy Male Subjects
The purpose of this study is to evaluate the safety and tolerability of AZD8165 and the pharmacokinetics of the metabolite AZ12971554 and plasma levels of the prodrug AZD8165 after escalating single oral low doses.
- Conditions
- Thrombin Inhibition
- Being tested
- AZD8165
- Keywords
- First time in man, healthy, thrombin inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD8165Drug
Oral suspension, 2 mg/mL and 20 mg/mL, single doses
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: AZD8165 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety variables (adverse events, Electrocardiograms, vital signs, safety labs)
Measured: Approximately 64 days including a screening period, 3 treatment periods, 2 washout periods, and a follow-up period.
Secondary outcomes (2)
Plasma and urine levels of AZD8165 and its active metabolite AZ12971554
Measured: Serial blood and urine samples will be taken over 24 hours after oral administration to evaluate AZD8165 and its active metabolite AZ12971554
Coagulation times (namely Activated Partial Thromboplastin Time,Ecarin Clotting Time, Thrombin Clotting Time
Measured: Serial blood samples will be taken over 24 hours after oral administration to evaluate Activated Partial Thromboplastin Time (APTT), Ecarin clotting Time (ECT), Thrombin Clotting Time (TCT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionAug 2010
- Study completionAug 2010
Why it stopped: The study pharmacodynamic stopping criteria were met after the first dosing group
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thrombin InhibitionStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ralph Schutz, MD, Principal investigator, Quintiles, Inc.Peter Held, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01150812
- Sponsor's protocol ID
- D2890C00001
- Status last verified
- Sep 2010
- First submitted
- 21 Jun 2010
- Last updated
- 17 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-center, Single-blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AZD8165 After Single Oral Ascending Doses in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01150812
- Acronym / sponsor ID
- D2890C00001
- Conditions
- Thrombin Inhibition
- Keywords
- First time in man, healthy, thrombin inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study pharmacodynamic stopping criteria were met after the first dosing group
- Enrolment
- 9 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 25 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and tolerability of AZD8165 and the pharmacokinetics of the metabolite AZ12971554 and plasma levels of the prodrug AZD8165 after escalating single oral low doses.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD8165 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Suitable veins for cannulation or repeated venipuncture
- Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and nor more than 100 kg
Key exclusion criteria (3 listed)
- History of any clinically significancy disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study
- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
- Personal or family history of bleeding disorders, or reasonable suspicion of vascular malformations, including aneurysms.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD8165Oral suspension, 2 mg/mL and 20 mg/mL, single doses | Drug | 1 |
Primary outcome
Safety variables (adverse events, Electrocardiograms, vital signs, safety labs)
Time frame: Approximately 64 days including a screening period, 3 treatment periods, 2 washout periods, and a follow-up period.
2 secondary outcomes
Plasma and urine levels of AZD8165 and its active metabolite AZ12971554
Time frame: Serial blood and urine samples will be taken over 24 hours after oral administration to evaluate AZD8165 and its active metabolite AZ12971554
Coagulation times (namely Activated Partial Thromboplastin Time,Ecarin Clotting Time, Thrombin Clotting Time
Time frame: Serial blood samples will be taken over 24 hours after oral administration to evaluate Activated Partial Thromboplastin Time (APTT), Ecarin clotting Time (ECT), Thrombin Clotting Time (TCT)
Results and safety
The study was stopped early (reason given: The study pharmacodynamic stopping criteria were met after the first dosing group). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2010.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralph Schutz, MD principal investigator
Quintiles, Inc.
Peter Held study director
AstraZeneca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD8165 in people with Thrombin Inhibition, run by AstraZeneca at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study pharmacodynamic stopping criteria were met after the first dosing group). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety variables (adverse events, Electrocardiograms, vital signs, safety labs) (time frame: Approximately 64 days including a screening period, 3 treatment periods, 2 washout periods, and a follow-up period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2010.