HealthyPhase 1NCT01343719
Single Rising Dose Study to Assess Safety, Tolerability and Pharmacokinetics of BI 661051.
A Phase 1 study testing BI 661051 in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
The objective of the current study is to investigate safety, tolerability, and pharmacokinetics of treatment with BI 661051 rising single doses administered as oral drinking solution (powder in bottle) in healthy male subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 661051
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2011to Jul 2011
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), 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 =18 and age =50 years.
- BMI =18.5 and BMI =30 kg/m2 (Body Mass Index).
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation.
Who cannot join
- Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance.
- Any 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 drug or its excipients) as judged clinically relevant by the investigator.
- Intake of drugs with a long half-life (>24 h) within at least 1 month or less than 10 half-lives of the respective drug prior to administration.
- 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 30 days 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/day).
- Drug abuse.
- Blood donation (more than 100 mL 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 of 2 mg to 350 mg of BI 661051 Administered as Oral Drinking Solution (Powder in Bottle) in Healthy Male Volunteers, b) to Explore the Relative Oral Bioavailability of a 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)
The objective of the current study is to investigate safety, tolerability, and pharmacokinetics of treatment with BI 661051 rising single doses administered as oral drinking solution (powder in bottle) in healthy male subjects.
The primary objective is to investigate the safety and tolerability of treatment with BI 661051.
Read more
The secondary objectives are (1) to evaluate the single dose pharmacokinetics of BI 661051, (2) to explore dose proportionality, (3) to explore the relative bioavailability when BI 661051 is administered as tablet at two dose levels compared to oral drinking solution and (4) to assess the effect on the bioavailability when BI 661051 is administered as oral drinking solution after intake of a high fat meal.
Pharmacodynamic parameters will not be determined within this study.
Read the detailed description
Purpose:
- Conditions
- Healthy
- Being tested
- BI 661051, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 661051Drug
medium dose solution for oral administration
BI 661051Drug
medium dose solution for oral administration
BI 661051Drug
medium dose solution for oral administration
BI 661051Drug
low dose solution for oral administration
BI 661051Drug
low dose solution for oral administration
BI 661051Drug
low dose solution for oral administration
BI 661051Drug
high dose solution for oral administration
BI 661051Drug
high dose solution for oral administration
BI 661051Drug
low dose tablet
PlaceboDrug
solution for administration
BI 661051Drug
medium dose tablet
| Study group | Role | What they receive |
|---|---|---|
| BI 661051 low dose, low | Experimental | solution for oral administration, single dose Receives: Drug: BI 661051 |
| BI 661051 low dose, medium | Experimental | solution for oral administration, single dose Receives: Drug: BI 661051 |
| BI 661051 low dose, high | Experimental | solution for oral administration, single dose Receives: Drug: BI 661051 |
| BI 661051 medium dose, low | Experimental | solution for oral administration, single dose Receives: Drug: BI 661051 |
| BI 661051 medium dose, medium | Experimental | solution for oral administration, single dose Receives: Drug: BI 661051 |
| BI 661051 medium dose, high | Experimental | solution for oral administration, single dose Receives: Drug: BI 661051 |
| BI 661051 high dose, low | Experimental | solution for oral administration, single dose Receives: Drug: BI 661051 |
| BI 661051 high dose, medium | Experimental | solution for oral administration, single dose Receives: Drug: BI 661051 |
| BI 661051 low dose | Experimental | tablet Receives: Drug: BI 661051 |
| BI 661051 medium dose | Experimental | tablet Receives: Drug: BI 661051 |
| Placebo | Placebo comparator | solution for oral administratrion Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of findings of physical examination
Measured: 14 weeks
Vital signs (blood pressure (BP), pulse rate (PR), respiratory rate [RR])
Measured: 14 weeks
Orthostasis test parameters
Measured: 14 weeks
Body temperature
Measured: 14 weeks
12-lead electrocardiogram (ECG) parameters (heart rate, PQ interval, QRS interval, uncorrected QT interval as well as Bazett- and Fridericia corrected QT interval)
Measured: 14 weeks
Clinical laboratory test parameters (haematology, clinical chemistry and urinalysis parameters)
Measured: 14 weeks
Occurrence of adverse events (AEs) on the level of Medical Dictionary for Regulatory Affairs (MedDRA) Preferred Terms and MedDRA System Organ Class
Measured: 14 weeks
Occurrence of findings detected by the pupillometry measurements
Measured: 14 weeks
Tolerability assessed by investigator
Measured: 14 weeks
Secondary outcomes (4)
Cmax (maximum measured concentration of the analyte in plasma)
Measured: 14 weeks
AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Measured: 14 weeks
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable analyte plasma concentration)
Measured: 14 weeks
Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionJul 2011
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01343719
- Sponsor's protocol ID
- 1296.1
- Other IDs
- 2010-022465-96
- Status last verified
- Oct 2013
- First submitted
- 19 Apr 2011
- Last updated
- 31 Oct 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 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 of 2 mg to 350 mg of BI 661051 Administered as Oral Drinking Solution (Powder in Bottle) in Healthy Male Volunteers, b) to Explore the Relative Oral Bioavailability of a 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
- NCT01343719
- Acronym / sponsor ID
- 1296.1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Jul 2011 (actual)
- First posted
- 28 Apr 2011 (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 objective of the current study is to investigate safety, tolerability, and pharmacokinetics of treatment with BI 661051 rising single doses administered as oral drinking solution (powder in bottle) in healthy male subjects.
The primary objective is to investigate the safety and tolerability of treatment with BI 661051.
The secondary objectives are (1) to evaluate the single dose pharmacokinetics of BI 661051, (2) to explore dose proportionality, (3) to explore the relative bioavailability when BI 661051 is administered as tablet at two dose levels compared to oral drinking solution and (4) to assess the effect on the bioavailability when BI 661051 is administered as oral drinking solution after intake of a high fat meal.
Pharmacodynamic parameters will not be determined within this study.
Detailed description
Purpose:
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| BI 661051 low dose, low | Experimental | Drug: BI 661051solution for oral administration, single dose |
| BI 661051 low dose, medium | Experimental | Drug: BI 661051solution for oral administration, single dose |
| BI 661051 low dose, high | Experimental | Drug: BI 661051solution for oral administration, single dose |
| BI 661051 medium dose, low | Experimental | Drug: BI 661051solution for oral administration, single dose |
| BI 661051 medium dose, medium | Experimental | Drug: BI 661051solution for oral administration, single dose |
| BI 661051 medium dose, high | Experimental | Drug: BI 661051solution for oral administration, single dose |
| BI 661051 high dose, low | Experimental | Drug: BI 661051solution for oral administration, single dose |
| BI 661051 high dose, medium | Experimental | Drug: BI 661051solution for oral administration, single dose |
| BI 661051 low dose | Experimental | Drug: BI 661051tablet |
| BI 661051 medium dose | Experimental | Drug: BI 661051tablet |
| Placebo | Placebo comparator | Drug: Placebosolution for oral administratrion |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), 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 =18 and age =50 years.
- BMI =18.5 and BMI =30 kg/m2 (Body Mass Index).
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation.
Key exclusion criteria (18 listed)
- Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance.
- Any 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 661051medium dose solution for oral administration | Drug | BI 661051 medium dose, low |
| BI 661051medium dose solution for oral administration | Drug | BI 661051 medium dose, medium |
| BI 661051medium dose solution for oral administration | Drug | BI 661051 medium dose, high |
| BI 661051low dose solution for oral administration | Drug | BI 661051 low dose, high |
| BI 661051low dose solution for oral administration | Drug | BI 661051 low dose, low |
| BI 661051low dose solution for oral administration | Drug | BI 661051 low dose, medium |
| BI 661051high dose solution for oral administration | Drug | BI 661051 high dose, low |
| BI 661051high dose solution for oral administration | Drug | BI 661051 high dose, medium |
| BI 661051low dose tablet | Drug | BI 661051 low dose |
| Placebosolution for administration | Drug | Placebo |
| BI 661051medium dose tablet | Drug | BI 661051 medium dose |
Primary outcome
Occurrence of findings of physical examination
Time frame: 14 weeks
Vital signs (blood pressure (BP), pulse rate (PR), respiratory rate [RR])
Time frame: 14 weeks
Orthostasis test parameters
Time frame: 14 weeks
Body temperature
Time frame: 14 weeks
12-lead electrocardiogram (ECG) parameters (heart rate, PQ interval, QRS interval, uncorrected QT interval as well as Bazett- and Fridericia corrected QT interval)
Time frame: 14 weeks
Clinical laboratory test parameters (haematology, clinical chemistry and urinalysis parameters)
Time frame: 14 weeks
Occurrence of adverse events (AEs) on the level of Medical Dictionary for Regulatory Affairs (MedDRA) Preferred Terms and MedDRA System Organ Class
Time frame: 14 weeks
Occurrence of findings detected by the pupillometry measurements
Time frame: 14 weeks
Tolerability assessed by investigator
Time frame: 14 weeks
4 secondary outcomes
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: 14 weeks
AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: 14 weeks
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable analyte plasma concentration)
Time frame: 14 weeks
Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)
Time frame: 14 weeks
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 31 Oct 2013.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 661051 in people with 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: finished, as of the sponsor's last update on 31 Oct 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. 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?
Occurrence of findings of physical examination (time frame: 14 weeks). The study lists 9 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 31 Oct 2013.