HealthyPhase 1NCT02273479
Pharmacokinetics and Safety of Asasantin Extended Release (RAD-SP) Capsules in Japanese Healthy Male Volunteers
A Phase 1 study testing Asasantin® in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to investigate pharmacokinetics, pharmacodynamics and safety of RAD-SP capsule in multiple administration to healthy adult male volunteers. Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Asasantin®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Jul 1999to Sep 1999
- 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 20 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers judged by the investigator as appropriate subjects on the basis of screening test results
- Age range: ≥ 20 years and ≤ 35 years
- Body weight between 50 and 80 kg
- Obesity is within ± 20% of the standard body weight
- Ability to provide written informed consent to participate in the study
Who cannot join
- History of drug allergy
- History of bronchial asthma
- History of drug abuse and alcohol abuse
- History of hemorrhagic tendency or hemorrhagic disease
- Volunteers who have experiences in playing sports such as boxing which may damage the brain
- Accidents associated with brain concussion and contusion (traffic accident, etc.)
Show all 13Show fewer
- Administration of other study drug within 4 months before start of administration of this study drug
- Collection of whole blood (≥ 400 ml) within 3 months before study drug administration
- Collection of component blood (≥ 400 ml) within 1 months before study drug administration
- Intake of some drug or other within 10 days before the study drug administration
- Excessive physical activities within the last 5 days prior to study drug administration
- Intake of alcohol within 3 days before study drug administration
- Volunteers judged by the investigator to be inappropriate as the subjects of study
About this study
Official title: Pharmacokinetics and Safety of Asasantin Extended Release (RAD-SP) 200/25 mg Capsules b.i.d. in Randomised, Double-blind, Placebo-controlled Study in Japanese Healthy Male Volunteers
Study to investigate pharmacokinetics, pharmacodynamics and safety of RAD-SP capsule in multiple administration to healthy adult male volunteers.
- Conditions
- Healthy
- Being tested
- Asasantin®, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asasantin®Drug
Asasantin® extended release (RAD-SP)
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Asasantin® | Experimental | Not described Receives: Drug: Asasantin® |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma drug concentration-time curve at steady state (AUCss)
Measured: up to 144 hours after first drug administration
Maximum drug plasma concentration at steady state (Cmax,ss)
Measured: up to 144 hours after first drug administration
Cmax,ss/AUCss
Measured: up to 144 hours after first drug administration
Minimum drug plasma concentration at steady state (Cmin,ss)
Measured: up to 144 hours after first drug administration
Time to reach Cmax (tmax)
Measured: up to 144 hours after first drug administration
Terminal half-life (t1/2)
Measured: up to 144 hours after first drug administration
Mean residence time (MRT)
Measured: up to 144 hours after first drug administration
Percent peak trough fluctuation (%PTF)
Measured: up to 144 hours after first drug administration
Secondary outcomes (7)
Platelet adenosine uptake inhibition rate (AUI)
Measured: up to 74 hours after first drug administration
Malondialdehyde (MDA) production inhibition rate
Measured: up to 74 hours after first drug administration
Thromboxane B2 (TXB2) production inhibition rate
Measured: up to 74 hours after first drug administration
Number of subjects with adverse events
Measured: up to 14 days after first drug administration
Number of subjects with abnormal changes in laboratory parameters
Measured: up to 14 days after first drug administration
Number of subjects with abnormal changes in vital signs
Measured: up to 14 days after first drug administration
Number of subjects with abnormal changes in electrocardiogram findings
Measured: up to 14 days after first drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study startJul 1999
- Primary completionSep 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02273479
- Sponsor's protocol ID
- 9.127
- Status last verified
- Oct 2014
- First submitted
- 23 Oct 2014
- Last updated
- 24 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Safety of Asasantin Extended Release (RAD-SP) 200/25 mg Capsules b.i.d. in Randomised, Double-blind, Placebo-controlled Study in Japanese Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02273479
- Acronym / sponsor ID
- 9.127
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 1999
- Primary completion
- Sep 1999 (actual)
- First posted
- 24 Oct 2014 (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.
Study to investigate pharmacokinetics, pharmacodynamics and safety of RAD-SP capsule in multiple administration to healthy adult male volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asasantin® | Experimental | Drug: Asasantin® |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male volunteers judged by the investigator as appropriate subjects on the basis of screening test results
- Age range: ≥ 20 years and ≤ 35 years
- Body weight between 50 and 80 kg
- Obesity is within ± 20% of the standard body weight
- Ability to provide written informed consent to participate in the study
Key exclusion criteria (13 listed)
- History of drug allergy
- History of bronchial asthma
- History of drug abuse and alcohol abuse
- History of hemorrhagic tendency or hemorrhagic disease
- Volunteers who have experiences in playing sports such as boxing which may damage the brain
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 |
|---|---|---|
| Asasantin®Asasantin® extended release (RAD-SP) | Drug | Asasantin® |
| Placebo | Drug | Placebo |
Primary outcome
Area under the plasma drug concentration-time curve at steady state (AUCss)
Time frame: up to 144 hours after first drug administration
Maximum drug plasma concentration at steady state (Cmax,ss)
Time frame: up to 144 hours after first drug administration
Cmax,ss/AUCss
Time frame: up to 144 hours after first drug administration
Minimum drug plasma concentration at steady state (Cmin,ss)
Time frame: up to 144 hours after first drug administration
Time to reach Cmax (tmax)
Time frame: up to 144 hours after first drug administration
Terminal half-life (t1/2)
Time frame: up to 144 hours after first drug administration
Mean residence time (MRT)
Time frame: up to 144 hours after first drug administration
Percent peak trough fluctuation (%PTF)
Time frame: up to 144 hours after first drug administration
7 secondary outcomes
Platelet adenosine uptake inhibition rate (AUI)
Time frame: up to 74 hours after first drug administration
Malondialdehyde (MDA) production inhibition rate
Time frame: up to 74 hours after first drug administration
Thromboxane B2 (TXB2) production inhibition rate
Time frame: up to 74 hours after first drug administration
Number of subjects with adverse events
Time frame: up to 14 days after first drug administration
Number of subjects with abnormal changes in laboratory parameters
Time frame: up to 14 days after first drug administration
Number of subjects with abnormal changes in vital signs
Time frame: up to 14 days after first drug administration
Number of subjects with abnormal changes in electrocardiogram findings
Time frame: up to 14 days after first drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Asasantin® in people with Healthy, run by Boehringer Ingelheim.
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 5 inclusion and 13 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: finished, as of the sponsor's last update on 24 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Area under the plasma drug concentration-time curve at steady state (AUCss) (time frame: up to 144 hours after first drug administration). The study lists 8 primary outcomes in all. 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 24 Oct 2014.