PainPhase 1NCT01145014
To Investigate Safety, Tolerability, and Pharmacokinetics of Treatment With BI 660848 Rising Single Doses (From 2 mg to 600 mg) Administered as Oral Drinking Solution (Powder in Bottle).
A Phase 1 study testing BI 660848 in people with Pain and Healthy, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
As a transition from preclinical investigations to clinical development in this first-in-human trial, safety, tolerability, and pharmacokinetics of BI 660848 will be assessed in human male volunteers using single rising oral doses in order to provide the basis for a potential ongoing clinical development of BI 660848… Read more about this study
- Who is it for?
- Ages 21 to 50 years, men onlyHealthy volunteers can take part
- What is being tested?
- BI 660848
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteGermany
- Study dates
- May 2010to Dec 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 21 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male based upon a complete medical history, including the physical examination, regarding vital signs (BP, PR), 12 lead ECG measurement, and clinical laboratory tests. There is no finding deviating from normal and of clinical relevance. There is no evidence of a clinically relevant concomitant disease.
- Age 21 and 50 years
- BMI 18.5 and <30 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation
Who cannot join
- Any finding of the medical examination (including BP, PR, and ECG measurements) deviating from normal and of clinical relevance
- Evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
Show all 18Show fewer
- History of relevant allergy/hypersensitivity (including allergy to the drug or its excipients) as judged clinically relevant by the investigator
- Intake of drugs with a long half-life (24 hours) within at least 1 month or less than 10 half-lives of the respective drug prior to randomisation
- Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to randomisation
- Participation in another trial with an investigational drug within 2 months prior to randomisation
- Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
- Inability to refrain from smoking on trial days as judged by the investigator
- Alcohol abuse (more than 30 g alcohol a day)
- Drug abuse
- Blood donation (more than 100 mL blood within 4 weeks prior to randomisation or during the trial)
- Excessive physical activities within 1 week prior to randomisation or during the trial
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of the study centre
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Placebo-controlled (Within Dose Groups) Phase I - Study to a) Assess Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses 2 mg to 600 mg of BI 660848 Administered as Oral Drinking Solution (Powder in Bottle) in Healthy Male Volunteers, b) to Explore the Relative Oral Bioavailability of an Immediate Release Tablet Formulation and c) to Assess the Impact of a High Fat Meal on the Oral Bioavailability of the Oral Drinking Solution (Powder in Bottle).
As a transition from preclinical investigations to clinical development in this first-in-human trial, safety, tolerability, and pharmacokinetics of BI 660848 will be assessed in human male volunteers using single rising oral doses in order to provide the basis for a potential ongoing clinical development of BI 660848 in the indication of neuropathic pain.
- Being tested
- BI 660848, Placebo
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 660848Drug
2 mg oral drinking solution
BI 660848Drug
10 mg oral drinking solution
BI 660848Drug
20 mg oral drinking solution
BI 660848Drug
50 mg oral drinking solution
BI 660848Drug
100 mg oral drinking solution
BI 660848Drug
150 mg oral drinking solution
BI 660848Drug
200 mg oral drinking solution
BI 660848Drug
400 mg oral drinking solution
BI 660848Drug
600 mg oral drinking solution
BI 660848Drug
10,0 mg immediate release tablet
BI 660848Drug
50,0 mg immediate release tablet
PlaceboDrug
matching placebo (oral drinking solution and IR tablets)
| Study group | Role | What they receive |
|---|---|---|
| BI 660848 2 mg | Experimental | oral drinking solution Receives: Drug: BI 660848 |
| BI 660848 10 mg | Experimental | oral drinking solution Receives: Drug: BI 660848 |
| BI 660848 20 mg | Experimental | oral drinking solution Receives: Drug: BI 660848 |
| BI 660848 50 mg | Experimental | oral drinking solution Receives: Drug: BI 660848 |
| BI 660848 100 mg | Experimental | oral drinking solution Receives: Drug: BI 660848 |
| BI 660848 150 mg | Experimental | oral drinking solution Receives: Drug: BI 660848 |
| BI 660848 200 mg | Experimental | oral drinking solution Receives: Drug: BI 660848 |
| BI 660848 400 mg | Experimental | oral drinking solution Receives: Drug: BI 660848 |
| BI 660848 600 mg | Experimental | oral drinking solution Receives: Drug: BI 660848 |
| BI 660848 10,0 mg | Experimental | immediate release tablet Receives: Drug: BI 660848 |
| BI 660848 50,0 mg | Experimental | immediate release tablet Receives: Drug: BI 660848 |
| Placebo | Experimental | matching placebo (oral drinking solution and IR tablets) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability (number and intensity of adverse events).
Measured: 4 months
Changes in blood pressure.
Measured: 4 months
Changes in pulse rate.
Measured: 4 months
Changes in respiratory rate.
Measured: 4 months
Changes in 12-lead ECG.
Measured: 4 months
Changes in clinical laboratory test parameters.
Measured: 4 months
Secondary outcomes (10)
Cmax (maximum measured concentration of the analyte in plasma)
Measured: 3 days
tmax (time from dosing to maximum measured concentration)
Measured: 3 days
AUC (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Measured: 3 days
t1/2 (terminal half-life of the analyte in plasma)
Measured: 3 days
MRT (mean residence time of the analyte in the body after drug intake)
Measured: 3 days
CL/F (apparent clearance of the analyte in plasma after extravascular administration)
Measured: 3 days
Vz/F (apparent volume of distribution during the terminal phase following an extravascular dose)
Measured: 3 days
Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)
Measured: 3 days
fet1-t2 (fraction of analyte eliminated in urine from the time point t1 to time point t2)
Measured: 3 days
CL R,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01145014
- Sponsor's protocol ID
- 1284.1
- Other IDs
- 2009-015995-90, 2009
- Status last verified
- Oct 2013
- First submitted
- 5 May 2010
- Last updated
- 1 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled (Within Dose Groups) Phase I - Study to a) Assess Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses 2 mg to 600 mg of BI 660848 Administered as Oral Drinking Solution (Powder in Bottle) in Healthy Male Volunteers, b) to Explore the Relative Oral Bioavailability of an Immediate Release Tablet Formulation and c) to Assess the Impact of a High Fat Meal on the Oral Bioavailability of the Oral Drinking Solution (Powder in Bottle).
- ClinicalTrials.gov ID
- NCT01145014
- Acronym / sponsor ID
- 1284.1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Dec 2010 (actual)
- First posted
- 16 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.
As a transition from preclinical investigations to clinical development in this first-in-human trial, safety, tolerability, and pharmacokinetics of BI 660848 will be assessed in human male volunteers using single rising oral doses in order to provide the basis for a potential ongoing clinical development of BI 660848 in the indication of neuropathic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| BI 660848 2 mg | Experimental | Drug: BI 660848oral drinking solution |
| BI 660848 10 mg | Experimental | Drug: BI 660848oral drinking solution |
| BI 660848 20 mg | Experimental | Drug: BI 660848oral drinking solution |
| BI 660848 50 mg | Experimental | Drug: BI 660848oral drinking solution |
| BI 660848 100 mg | Experimental | Drug: BI 660848oral drinking solution |
| BI 660848 150 mg | Experimental | Drug: BI 660848oral drinking solution |
| BI 660848 200 mg | Experimental | Drug: BI 660848oral drinking solution |
| BI 660848 400 mg | Experimental | Drug: BI 660848oral drinking solution |
| BI 660848 600 mg | Experimental | Drug: BI 660848oral drinking solution |
| BI 660848 10,0 mg | Experimental | Drug: BI 660848immediate release tablet |
| BI 660848 50,0 mg | Experimental | Drug: BI 660848immediate release tablet |
| Placebo | Experimental | Drug: Placebomatching placebo (oral drinking solution and IR tablets) |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male based upon a complete medical history, including the physical examination, regarding vital signs (BP, PR), 12 lead ECG measurement, and clinical laboratory tests. There is no finding deviating from normal and of clinical relevance. There is no evidence of a clinically relevant concomitant disease.
- Age 21 and 50 years
- BMI 18.5 and <30 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation
Key exclusion criteria (18 listed)
- Any finding of the medical examination (including BP, PR, and ECG measurements) deviating from normal and of clinical relevance
- Evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
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 6608482 mg oral drinking solution | Drug | BI 660848 2 mg |
| BI 66084810 mg oral drinking solution | Drug | BI 660848 10 mg |
| BI 66084820 mg oral drinking solution | Drug | BI 660848 20 mg |
| BI 66084850 mg oral drinking solution | Drug | BI 660848 50 mg |
| BI 660848100 mg oral drinking solution | Drug | BI 660848 100 mg |
| BI 660848150 mg oral drinking solution | Drug | BI 660848 150 mg |
| BI 660848200 mg oral drinking solution | Drug | BI 660848 200 mg |
| BI 660848400 mg oral drinking solution | Drug | BI 660848 400 mg |
| BI 660848600 mg oral drinking solution | Drug | BI 660848 600 mg |
| BI 66084810,0 mg immediate release tablet | Drug | BI 660848 10,0 mg |
| BI 66084850,0 mg immediate release tablet | Drug | BI 660848 50,0 mg |
| Placebomatching placebo (oral drinking solution and IR tablets) | Drug | Placebo |
Primary outcome
Safety and tolerability (number and intensity of adverse events).
Time frame: 4 months
Changes in blood pressure.
Time frame: 4 months
Changes in pulse rate.
Time frame: 4 months
Changes in respiratory rate.
Time frame: 4 months
Changes in 12-lead ECG.
Time frame: 4 months
Changes in clinical laboratory test parameters.
Time frame: 4 months
10 secondary outcomes
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: 3 days
tmax (time from dosing to maximum measured concentration)
Time frame: 3 days
AUC (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: 3 days
t1/2 (terminal half-life of the analyte in plasma)
Time frame: 3 days
MRT (mean residence time of the analyte in the body after drug intake)
Time frame: 3 days
CL/F (apparent clearance of the analyte in plasma after extravascular administration)
Time frame: 3 days
Vz/F (apparent volume of distribution during the terminal phase following an extravascular dose)
Time frame: 3 days
Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)
Time frame: 3 days
fet1-t2 (fraction of analyte eliminated in urine from the time point t1 to time point t2)
Time frame: 3 days
CL R,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
Time frame: 3 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2013.
- Related InfoLink provided by the sponsor.
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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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
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 BI 660848 in people with Pain and Healthy, run by Boehringer Ingelheim at 1 site in Germany.
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 18 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 1 Nov 2013. 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 Germany. 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. 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 and tolerability (number and intensity of adverse events). (time frame: 4 months). 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 1 Nov 2013.