HealthyPhase 1NCT02244203
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 60732 in Healthy Male Volunteers
A Phase 1 study testing BI 60732 in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Single Rising Dose (SRD) study: First evaluation of safety, tolerability, pharmacokinetics and pharmacodynamics of BI 60732 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
- Healthy
- What is being tested?
- BI 60732
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to Jul 2009
- 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
- Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
- Age ≥ 18 and Age ≤ 45 years
- BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice and the local legislation
Who cannot join
- Any finding of the medical examination deviating from normal and of clinical relevance. Repeated measurement of a systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
Show all 28Show fewer
- Chronic or relevant acute infections
- History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
- Intake of drugs within one month or less than 10 half-lives of the respective drug prior to first study drug administration except if a relevant interaction can be ruled out
- Participation in another trial with an investigational drug within 2 months prior to first study drug administration
- Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
- Alcohol abuse (average consumption of more than 30 g / day)
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to the start of study)
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of trial site
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
- A history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalaemia, family history of Long QT Syndrome)
- Anaemia at screening
- Subjects who in the investigator's judgement are perceived as having an increased risk of bleeding, for example because of:
- Hemorrhagic disorders or bleeding diathesis
- Occult blood in faeces or haematuria
- Trauma or surgery within the last month or as long as an excessive risk of bleeding persists after these events, or planned surgery during trial participation
- History of arteriovenous malformation or aneurysm
- History of gastroduodenal ulcer disease or gastrointestinal haemorrhage
- History of intracranial, intraocular, spinal, retroperitoneal, or atraumatic intraarticular bleeding
- Use of drugs that may interfere with haemostasis during trial conduct (e.g. acetylsalicylic acid or other non-steroidal anti-inflammatory drugs)
- Thrombocytopenia (platelet count < 100/nL)
About this study
Official title: Investigation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of 0.25, 0.5, 1, 2, 4, 20, 50, 100, 150 and 200 mg BI 60732 Powder in Bottle (PIB) Administered to Healthy Male Volunteers in a Randomised, Double Blind, Placebo Controlled Phase I Trial
Single Rising Dose (SRD) study: First evaluation of safety, tolerability, pharmacokinetics and pharmacodynamics of BI 60732
- Conditions
- Healthy
- Being tested
- BI 60732, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 60732Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Single rising doses of BI 60732 | Experimental | Not described Receives: Drug: BI 60732 |
| 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.
Number of patients with clinically relevant changes in vital signs (blood pressure (BP), pulse rate (PR))
Measured: up to day 21 after start of treatment
Number of patients with clinically relevant changes in 12-lead ECG
Measured: up to day 21 after start of treatment
Number of patients with clinically relevant changes in laboratory parameters
Measured: up to day 21 after start of treatment
Number of patients with clinically relevant changes in coagulation parameters
Parameters:
- Activated partial thromboplastin time (aPTT)
- Prothrombin time (PT)
- HepTest®
Measured: up to 72 hours after start of treatment
Number of patients with adverse events
Measured: up to 6 weeks
Global assessment of tolerability by investigator on a 4-point scale
Measured: up to 21 days after start of treatment
Secondary outcomes (21)
Maximum measured concentration of the analyte in plasma (Cmax)
Measured: up to 264 hours after start of treatment
Time from dosing to maximum measured concentration of the analyte in plasma (tmax)
Measured: up to 264 hours after start of treatment
Area under the concentration-time curve of the analyte in plasma (AUC)
Measured: up to 264 hours after start of treatment
Terminal rate constant of the analyte in plasma (λz)
Measured: up to 264 hours after start of treatment
Terminal half-life of the analyte in plasma (t1/2)
Measured: up to 264 hours after start of treatment
Mean residence time of the analyte in the body after oral administration (MRTpo)
Measured: up to 264 hours after start of treatment
Apparent clearance of the analyte in plasma after extravascular administration (CL/F)
Measured: up to 264 hours after start of treatment
Amount of analyte eliminated in urine from the time point t1 to time point t2 (Aet1-t2)
Measured: up to 264 hours after start of treatment
Fraction of analyte eliminated in urine from time point t1 to time point t2 (fet1-t2)
Measured: up to 264 hours after start of treatment
Renal clearance of the analyte from the time point t1 until the time point t2 (CLR,t1-t2)
Measured: Pre-dose, up to 264 hours after start of treatment
Changes in activated partial thromboplastin time (aPTT)
Measured: Pre-dose, up to 72 hours after start of treatment
Changes in prothrombin time (PT)
Measured: Pre-dose, up to 72 hours after start of treatment
Prolongation of coagulation time by Heptest®
Measured: up to 72 hours after start of treatment
Inhibition of FXa activity
Russel's Viper Venom (RVV)
Measured: Pre-dose up to 168 hours after start of treatment
Percentage inhibition of endogenous thrombin generation
Measured: up to 24 hours after start of treatment
Percentage peak inhibition of thrombin generation
Measured: up to 24 hours after start of treatment
Relative prolongation of time to maximum inhibition of thrombin generation
Measured: up to 24 hours after start of treatment
Relative prolongation of lag time of thrombin generation
Measured: up to 24 hours after start of treatment
Maximum effect (Emax)
Measured: up to 168 hours after start of treatment
Time to maximum effect (tmax)
Measured: up to 168 hours after start of treatment
Area under the effect curve (AUEC)
Measured: up to 168 hours after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startFeb 2009
- Primary completionJul 2009
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
- Single group
- Masking
- Double blind
- Enrolment
- 56 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
- NCT02244203
- Sponsor's protocol ID
- 1267.1
- Status last verified
- Sep 2014
- First submitted
- 18 Sep 2014
- Last updated
- 19 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of 0.25, 0.5, 1, 2, 4, 20, 50, 100, 150 and 200 mg BI 60732 Powder in Bottle (PIB) Administered to Healthy Male Volunteers in a Randomised, Double Blind, Placebo Controlled Phase I Trial
- ClinicalTrials.gov ID
- NCT02244203
- Acronym / sponsor ID
- 1267.1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jul 2009 (actual)
- First posted
- 19 Sep 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.
Single Rising Dose (SRD) study: First evaluation of safety, tolerability, pharmacokinetics and pharmacodynamics of BI 60732
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single rising doses of BI 60732 | Experimental | Drug: BI 60732 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
- Age ≥ 18 and Age ≤ 45 years
- BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice and the local legislation
Key exclusion criteria (28 listed)
- Any finding of the medical examination deviating from normal and of clinical relevance. Repeated measurement of a systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
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 |
|---|---|---|
| BI 60732 | Drug | Single rising doses of BI 60732 |
| Placebo | Drug | Placebo |
Primary outcome
Number of patients with clinically relevant changes in vital signs (blood pressure (BP), pulse rate (PR))
Time frame: up to day 21 after start of treatment
Number of patients with clinically relevant changes in 12-lead ECG
Time frame: up to day 21 after start of treatment
Number of patients with clinically relevant changes in laboratory parameters
Time frame: up to day 21 after start of treatment
Number of patients with clinically relevant changes in coagulation parameters
Time frame: up to 72 hours after start of treatment
Parameters: * Activated partial thromboplastin time (aPTT) * Prothrombin time (PT) * HepTest®
Number of patients with adverse events
Time frame: up to 6 weeks
Global assessment of tolerability by investigator on a 4-point scale
Time frame: up to 21 days after start of treatment
21 secondary outcomes
Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: up to 264 hours after start of treatment
Time from dosing to maximum measured concentration of the analyte in plasma (tmax)
Time frame: up to 264 hours after start of treatment
Area under the concentration-time curve of the analyte in plasma (AUC)
Time frame: up to 264 hours after start of treatment
Terminal rate constant of the analyte in plasma (λz)
Time frame: up to 264 hours after start of treatment
Terminal half-life of the analyte in plasma (t1/2)
Time frame: up to 264 hours after start of treatment
Mean residence time of the analyte in the body after oral administration (MRTpo)
Time frame: up to 264 hours after start of treatment
Apparent clearance of the analyte in plasma after extravascular administration (CL/F)
Time frame: up to 264 hours after start of treatment
Amount of analyte eliminated in urine from the time point t1 to time point t2 (Aet1-t2)
Time frame: up to 264 hours after start of treatment
Fraction of analyte eliminated in urine from time point t1 to time point t2 (fet1-t2)
Time frame: up to 264 hours after start of treatment
Renal clearance of the analyte from the time point t1 until the time point t2 (CLR,t1-t2)
Time frame: Pre-dose, up to 264 hours after start of treatment
Changes in activated partial thromboplastin time (aPTT)
Time frame: Pre-dose, up to 72 hours after start of treatment
Changes in prothrombin time (PT)
Time frame: Pre-dose, up to 72 hours after start of treatment
Prolongation of coagulation time by Heptest®
Time frame: up to 72 hours after start of treatment
Inhibition of FXa activity
Time frame: Pre-dose up to 168 hours after start of treatment
Percentage inhibition of endogenous thrombin generation
Time frame: up to 24 hours after start of treatment
Percentage peak inhibition of thrombin generation
Time frame: up to 24 hours after start of treatment
Relative prolongation of time to maximum inhibition of thrombin generation
Time frame: up to 24 hours after start of treatment
Relative prolongation of lag time of thrombin generation
Time frame: up to 24 hours after start of treatment
Maximum effect (Emax)
Time frame: up to 168 hours after start of treatment
Time to maximum effect (tmax)
Time frame: up to 168 hours after start of treatment
Area under the effect curve (AUEC)
Time frame: up to 168 hours after start of treatment
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 19 Sep 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 BI 60732 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 4 inclusion and 28 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 19 Sep 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?
Number of patients with clinically relevant changes in vital signs (blood pressure (BP), pulse rate (PR)) (time frame: up to day 21 after start of treatment). The study lists 6 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 19 Sep 2014.