HealthyPhase 1NCT01215773
Pharmacokinetics, Safety and Tolerability of BI 671800 HEA Given Over 7 Days. A Randomised, Double Blind, Placebo Controlled Within Dose Groups Phase I Study in Healthy Male and Female Volunteers.
A Phase 1 study testing BI 671800 in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
The main objectives of the multiple dose study are to investigate the safety, tolerability pharmacokinetics of BI 671800 HEA in healthy male and female volunteers following multiple oral administration of BI 671800 Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 671800
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Oct 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females according to the following criteria: Based upon a complete medical history, including physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
- Age 21 to 50 years (incl.)
- Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.)
- 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 21Show fewer
- History of relevant allergy or hypersensitivity (including allergy to drug or its excipients)
- Intake of drugs with a long half life (>24 h) within one month or less than 10 half-lives of the respective drug prior to first study drug administration
- Participation in another trial with an investigational drug within 2 months prior to administration or during the trial
- Smoker (more than 10 cigarettes or 3 cigars or 3 pipes daily)
- Alcohol abuse (average consumption of more than 20 g/day in females and 30 g/day in males) or positive alcohol test
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to day 1 of visit 2)
- Any laboratory value outside the reference range that is of clinical relevance, especially repeated Alanine transaminase (ALT), Aspartate transaminase (AST), Gamma-glutamyl-transferase (GGT), Alkaline phosphatase (ALP) or total bilirubin above upper limit of normal (ULN) at screening and not resolved before dosing.
- Inability to comply with dietary regimen of trial site
- Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval within 10 days prior to administration or during the trial, and CYP2C8 substrates such as amiodarone, amodiaquine, paclitaxel, rosiglitazone, pioglitazone and repaglinide or CYP2C9 such as warfarin, tolbutamide, phenytoin, losartan, acenocoumarol within 1 month or six half lives (whichever is greater).
- Repeated demonstration of a QTc interval >450 ms, PR interval >230 ms or a QRS interval >120 ms; history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalaemia, family history of Long QT Syndrome)
- For female subjects of childbearing potential only:
- Positive pregnancy test, pregnancy or planning to become pregnant during the study or within 2 months after study completion
- No adequate contraception during the study including three months before first dosing until 2 month after study completion, e.g. not any of the following: implants, injectables, combined hormonal contraceptives, intrauterine device, or surgical sterilisation (including hysterectomy). In addition to this, also a barrier method (e.g. condom) will be required, if the female is not surgically sterilised.
- Lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetics, Safety and Tolerability of BI 671800 HEA Given 200 mg b.i.d. or 400 mg b.i.d. Over 7 Days. A Randomised, Double Blind, Placebo Controlled Within Dose Groups Phase I Study in Healthy Male and Female Volunteers.
The main objectives of the multiple dose study are to investigate the safety, tolerability pharmacokinetics of BI 671800 HEA in healthy male and female volunteers following multiple oral administration of BI 671800
- Conditions
- Healthy
- Being tested
- Placebo, BI 671800
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Matching to HEA 200 mg tablet, oral administration
BI 671800Drug
High dose oral administration
BI 671800Drug
Medium dose oral administration
| Study group | Role | What they receive |
|---|---|---|
| BI 671800 HEA medium dose | Experimental | Tablet, oral administration with 240 mL of water for each treatment Receives: Drug: BI 671800 |
| BI 671800 HEA high dose | Experimental | 2 Tablets, oral administration with 240 mL of water for each treatment Receives: Drug: BI 671800 |
| Placebo | Placebo comparator | Matching to HEA 200 mg tablets, oral administration Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vital signs (pulse rate (PR))
Measured: 12 weeks
Clinical laboratory test (clinical chemistry)
Measured: 12 weeks
Clinical laboratory test (urinalysis)
Measured: 12 weeks
Physical examination
Measured: 12 weeks
Vital signs (blood pressure (BP))
Measured: 12 weeks
12-lead ECG (electrocardiogram)
Measured: 12 weeks
Clinical laboratory test (haematology)
Measured: 12 weeks
Adverse events
Measured: 12 weeks
Assessment of tolerability by investigator
Measured: 12 weeks
Secondary outcomes (21)
Cmax (maximum plasma concentration of BI 671800 or BI 600957)
Measured: up to day 12 post treatment
tmax (time from dosing until maximum concentration of BI 671800 or BI 600957 is measured)
Measured: up to day 12 post treatment
AUC0-infinity (area under the plasma concentration-time curve of BI 671800 or BI 600957 from time of dosing extrapolated to infinity)
Measured: up to day 12 post treatment
AUCτ,1 (area under the plasma concentration-time curve of BI 671800 or BI 600957 for the complete dosing interval τ)
Measured: up to day 12 post treatment
AUC0-tz (area under the plasma concentration-time curve of BI 671800 or BI 600957 from time of dosing to time tz of last quantifiable concentration)
Measured: up to day 12 post treatment
Cmax,ss (maximum plasma concentration of BI 671800 or BI 600957 at steady state)
Measured: up to day 12 post treatment
tmax,ss (time from dosing until maximum concentration of BI 671800 or BI 600957 at steady state is measured)
Measured: up to day 12 post treatment
Cavg,ss (average measured plasma concentration of BI 671800 or BI 600957 at steady state)
Measured: up to day 12 post treatment
AUCτ,ss (area under the plasma concentration-time curve of BI 671800 or BI 600957 at steady state for the complete dosing interval τ)
Measured: up to day 12 post treatment
λz,ss (terminal rate constant of BI 671800 or BI 600957 in plasma at steady state)
Measured: up to day 12 post treatment
t1/2,ss (terminal half-life of BI 671800 or BI 600957 in plasma at steady state)
Measured: up to day 12 post treatment
MRTpo,ss (mean residence time of BI 671800 in the body at steady state after oral administration)
Measured: up to day 12 post treatment
CL/F,ss (apparent clearance of BI 671800 at steady state following oral administration)
Measured: up to day 12 post treatment
Vz/F,ss (apparent volume of distribution of BI 671800 during the terminal phase at steady state following oral administration)
Measured: up to day 12 post treatment
RAUCτ,ss,M/P (ratio of AUCτ,ss of the BI 600957 to AUCτ,ss of BI 671800)
Measured: up to day 12 post treatment
RCmax,ss,M/P (ratio of Cmax,ss of the BI 600957 to Cmax,ss of BI 671800)
Measured: up to day 12 post treatment
accumulation ratios RA,Cmax
Measured: up to day 12 post treatment
accumulation ratios RA,AUC
Measured: up to day 12 post treatment
peak-trough fluctuation (PTF) of BI 671800
Measured: up to day 12 post treatment
peak-trough fluctuation (PTF) of BI 600957
Measured: up to day 12 post treatment
linearity index (LI) of BI 671800 in plasma
Measured: up to day 12 post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startOct 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 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
- 24 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
- NCT01215773
- Sponsor's protocol ID
- 1268.59
- Other IDs
- 2009-016369-27, 2009
- Status last verified
- Oct 2013
- First submitted
- 29 Sep 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
- Pharmacokinetics, Safety and Tolerability of BI 671800 HEA Given 200 mg b.i.d. or 400 mg b.i.d. Over 7 Days. A Randomised, Double Blind, Placebo Controlled Within Dose Groups Phase I Study in Healthy Male and Female Volunteers.
- ClinicalTrials.gov ID
- NCT01215773
- Acronym / sponsor ID
- 1268.59
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Dec 2010 (actual)
- First posted
- 7 Oct 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 main objectives of the multiple dose study are to investigate the safety, tolerability pharmacokinetics of BI 671800 HEA in healthy male and female volunteers following multiple oral administration of BI 671800
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BI 671800 HEA medium dose | Experimental | Drug: BI 671800Tablet, oral administration with 240 mL of water for each treatment |
| BI 671800 HEA high dose | Experimental | Drug: BI 6718002 Tablets, oral administration with 240 mL of water for each treatment |
| Placebo | Placebo comparator | Drug: PlaceboMatching to HEA 200 mg tablets, oral administration |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males and females according to the following criteria: Based upon a complete medical history, including physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
- Age 21 to 50 years (incl.)
- Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.)
- 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 (21 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 |
|---|---|---|
| PlaceboMatching to HEA 200 mg tablet, oral administration | Drug | Placebo |
| BI 671800High dose oral administration | Drug | BI 671800 HEA high dose |
| BI 671800Medium dose oral administration | Drug | BI 671800 HEA medium dose |
Primary outcome
Vital signs (pulse rate (PR))
Time frame: 12 weeks
Clinical laboratory test (clinical chemistry)
Time frame: 12 weeks
Clinical laboratory test (urinalysis)
Time frame: 12 weeks
Physical examination
Time frame: 12 weeks
Vital signs (blood pressure (BP))
Time frame: 12 weeks
12-lead ECG (electrocardiogram)
Time frame: 12 weeks
Clinical laboratory test (haematology)
Time frame: 12 weeks
Adverse events
Time frame: 12 weeks
Assessment of tolerability by investigator
Time frame: 12 weeks
21 secondary outcomes
Cmax (maximum plasma concentration of BI 671800 or BI 600957)
Time frame: up to day 12 post treatment
tmax (time from dosing until maximum concentration of BI 671800 or BI 600957 is measured)
Time frame: up to day 12 post treatment
AUC0-infinity (area under the plasma concentration-time curve of BI 671800 or BI 600957 from time of dosing extrapolated to infinity)
Time frame: up to day 12 post treatment
AUCτ,1 (area under the plasma concentration-time curve of BI 671800 or BI 600957 for the complete dosing interval τ)
Time frame: up to day 12 post treatment
AUC0-tz (area under the plasma concentration-time curve of BI 671800 or BI 600957 from time of dosing to time tz of last quantifiable concentration)
Time frame: up to day 12 post treatment
Cmax,ss (maximum plasma concentration of BI 671800 or BI 600957 at steady state)
Time frame: up to day 12 post treatment
tmax,ss (time from dosing until maximum concentration of BI 671800 or BI 600957 at steady state is measured)
Time frame: up to day 12 post treatment
Cavg,ss (average measured plasma concentration of BI 671800 or BI 600957 at steady state)
Time frame: up to day 12 post treatment
AUCτ,ss (area under the plasma concentration-time curve of BI 671800 or BI 600957 at steady state for the complete dosing interval τ)
Time frame: up to day 12 post treatment
λz,ss (terminal rate constant of BI 671800 or BI 600957 in plasma at steady state)
Time frame: up to day 12 post treatment
t1/2,ss (terminal half-life of BI 671800 or BI 600957 in plasma at steady state)
Time frame: up to day 12 post treatment
MRTpo,ss (mean residence time of BI 671800 in the body at steady state after oral administration)
Time frame: up to day 12 post treatment
CL/F,ss (apparent clearance of BI 671800 at steady state following oral administration)
Time frame: up to day 12 post treatment
Vz/F,ss (apparent volume of distribution of BI 671800 during the terminal phase at steady state following oral administration)
Time frame: up to day 12 post treatment
RAUCτ,ss,M/P (ratio of AUCτ,ss of the BI 600957 to AUCτ,ss of BI 671800)
Time frame: up to day 12 post treatment
RCmax,ss,M/P (ratio of Cmax,ss of the BI 600957 to Cmax,ss of BI 671800)
Time frame: up to day 12 post treatment
accumulation ratios RA,Cmax
Time frame: up to day 12 post treatment
accumulation ratios RA,AUC
Time frame: up to day 12 post treatment
peak-trough fluctuation (PTF) of BI 671800
Time frame: up to day 12 post treatment
peak-trough fluctuation (PTF) of BI 600957
Time frame: up to day 12 post treatment
linearity index (LI) of BI 671800 in plasma
Time frame: up to day 12 post 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 1 Nov 2013.
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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 671800 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 21 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 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. 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?
Vital signs (pulse rate (PR)) (time frame: 12 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 1 Nov 2013.