HealthyPhase 1NCT01205373
A Phase I Trial to Investigate the Metabolism and Pharmacokinetics as Well as Safety and Tolerability of a Single Dose BI671800 HEA Administered as an Oral Solution of the Choline Salt in Healthy Male Volunteers
A Phase 1 study testing BI 671800 in people with Healthy, run by Boehringer Ingelheim at 1 site in United States.
Trial summary
The main objectives of the present study are to investigate the basic pharmacokinetics of BI 671800, its major metabolite CD6384, and 14C-radioactivity, including mass balance, excretion pathways and metabolism following a single oral dose of 400 mg [14C]BI 671800 HEA to healthy male volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy 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?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Oct 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 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males according to a complete medical history, including the physical examination (to be performed at Day -1), vital signs (blood pressure, pulse rate), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
- Age 18 to 55 years, inclusive
- Body mass index 18.0 to 30.0 kg/m2, inclusive
- 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 blood pressure, pulse rate, 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 25Show fewer
- History of relevant allergy/hypersensitivity (including allergy to study drug or its excipients)
- Use of any prescription drugs 30 days prior to screening.
- Use of any over-the-counter, non-prescription preparations (including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) within 7 days prior to Check-in, unless deemed acceptable by the Investigator
- Participation in another trial with an investigational drug within 2 months prior to administration or during the trial
- Smoker (>10 cigarettes or >3 cigars or >3 pipes/day) or positive urine cotinine test at screening and check-in (Day -1)
- Inability to refrain from smoking during the stay in the trial centre
- Alcohol abuse (more than on average 2 units of alcoholic beverages per day or more than 14 units per week. One unit equals 1 pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or one shot (25 mL) of 40% spirit, or positive urine alcohol test at screening or check-in (Day -1)
- Drug abuse
- Blood donation (>100 mL within 60 days prior to study drug administration or during the trial)
- Excessive physical activity (within 1 week prior to administration or during the trial until follow-up examination)
- Any laboratory value outside the reference range that is of clinical relevance according to the investigator
- Inability to comply with dietary regimen of study centre
- A marked baseline prolongation of QT or QTc interval, history of additional risk factors for torsade de pointes (e.g. heart failure, hypokalaemia, family history of long QT syndrome)
- Veins unsuitable for blood sampling
- Exposure to diagnostic radiation for occupational reasons or during participation in a clinical trial in the previous year (except dental X-rays and plain X-rays of thorax and bony skeleton [excluding spinal column])
- Irregular defecation pattern (less than once per day)
- Unwillingness to use adequate contraception (condom plus another form of contraception e.g. spermicide, oral contraceptive taken by female partner, sterilisation, intrauterine device) during the entire study from the time of the first intake of study drug until 3 months after the last intake
- Any laboratory value outside the reference range that is of clinical relevance, especially repeated Alanine transaminase (ALT), Aspartate transaminase (AST), Gamma-glutamyltransferase (GGT), alkaline phosphatase, or total bilirubin above upper limit of normal at screening and not resolved before dosing
- 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 Cytochrome P-450 (CYP)2C8 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
1268.7.001 Boehringer Ingelheim Investigational Site
Madison, Wisconsin
About this study
Official title: A Phase I Trial to Investigate the Metabolism and Pharmacokinetics of an Open-label Single Dose of 400 mg [14C]BI 671800 HEA Administered as an Oral Solution of the Choline Salt in Healthy Male Volunteers.
The main objectives of the present study are to investigate the basic pharmacokinetics of BI 671800, its major metabolite CD6384, and 14C-radioactivity, including mass balance, excretion pathways and metabolism following a single oral dose of 400 mg [14C]BI 671800 HEA to healthy male volunteers. Secondary objectives are to evaluate the safety and tolerability following a single oral dose of 400 mg [14C]BI 671800 HEA to healthy male volunteers.
- Conditions
- Healthy
- Being tested
- BI 671800
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 671800Drug
High dose oral drinking solution
| Study group | Role | What they receive |
|---|---|---|
| BI 671800 high dose | Experimental | Oral drinking solution Receives: Drug: BI 671800 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Individual time course profiles of 14C-radioactivity (in nmol eq/L or nmol eq/kg for faeces) in whole blood, plasma, urine, and faeces
Measured: up to 336 h post treatment
Individual time course profiles of BI 671800 and its major metabolite CD6384 in plasma and urine
Measured: up to 336 h post treatment
Rate and extent of excretion mass balance based on the total radioactivity in urine and faeces
Measured: up to 336 h post treatment
Elucidation of metabolite structures and identification of major metabolites in plasma, urine, and faeces (if feasible) in comparison with various animal species (to be presented in a separate report)
Measured: up to 336 h post treatment
Cblood cells/Cplasma ratio of 14C-radioactivity
Measured: up to 168 h post treatment
concentrations of BI 671800 and its metabolite CD6384 in plasma and urine
Measured: up to 336 h post treatment
concentrations of 14C-radioactivity in whole blood, plasma, urine, and faeces
Measured: up to 336 h post treatment
Secondary outcomes (7)
Changes from Baseline in Vital signs (pulse rate)
Measured: up to 23 days post treatment
Changes from Baseline in Physical examination
Measured: up to 23 days post treatment
Changes from Baseline in Vital signs (blood pressure)
Measured: up to 23 days post treatment
Changes from Baseline in 12-lead electrocardiogram (ECG)
Measured: up to 23 days post treatment
Changes from Baseline in Clinical laboratory tests
Measured: up to 23 days post treatment
Occurrence of Adverse Events
Measured: up to 23 days post treatment
Assessment of tolerability by investigator
Measured: up to 23 days post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionOct 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 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
- NCT01205373
- Sponsor's protocol ID
- 1268.7
- Other IDs
- 2009-016370-32, 2009
- Status last verified
- Oct 2013
- First submitted
- 17 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
- A Phase I Trial to Investigate the Metabolism and Pharmacokinetics of an Open-label Single Dose of 400 mg [14C]BI 671800 HEA Administered as an Oral Solution of the Choline Salt in Healthy Male Volunteers.
- ClinicalTrials.gov ID
- NCT01205373
- Acronym / sponsor ID
- 1268.7
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Oct 2010 (actual)
- First posted
- 20 Sep 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 present study are to investigate the basic pharmacokinetics of BI 671800, its major metabolite CD6384, and 14C-radioactivity, including mass balance, excretion pathways and metabolism following a single oral dose of 400 mg [14C]BI 671800 HEA to healthy male volunteers. Secondary objectives are to evaluate the safety and tolerability following a single oral dose of 400 mg [14C]BI 671800 HEA to healthy male volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BI 671800 high dose | Experimental | Drug: BI 671800Oral drinking solution |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males according to a complete medical history, including the physical examination (to be performed at Day -1), vital signs (blood pressure, pulse rate), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
- Age 18 to 55 years, inclusive
- Body mass index 18.0 to 30.0 kg/m2, inclusive
- 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 (25 listed)
- Any finding of the medical examination (including blood pressure, pulse rate, 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 671800High dose oral drinking solution | Drug | BI 671800 high dose |
Primary outcome
Individual time course profiles of 14C-radioactivity (in nmol eq/L or nmol eq/kg for faeces) in whole blood, plasma, urine, and faeces
Time frame: up to 336 h post treatment
Individual time course profiles of BI 671800 and its major metabolite CD6384 in plasma and urine
Time frame: up to 336 h post treatment
Rate and extent of excretion mass balance based on the total radioactivity in urine and faeces
Time frame: up to 336 h post treatment
Elucidation of metabolite structures and identification of major metabolites in plasma, urine, and faeces (if feasible) in comparison with various animal species (to be presented in a separate report)
Time frame: up to 336 h post treatment
Cblood cells/Cplasma ratio of 14C-radioactivity
Time frame: up to 168 h post treatment
concentrations of BI 671800 and its metabolite CD6384 in plasma and urine
Time frame: up to 336 h post treatment
concentrations of 14C-radioactivity in whole blood, plasma, urine, and faeces
Time frame: up to 336 h post treatment
7 secondary outcomes
Changes from Baseline in Vital signs (pulse rate)
Time frame: up to 23 days post treatment
Changes from Baseline in Physical examination
Time frame: up to 23 days post treatment
Changes from Baseline in Vital signs (blood pressure)
Time frame: up to 23 days post treatment
Changes from Baseline in 12-lead electrocardiogram (ECG)
Time frame: up to 23 days post treatment
Changes from Baseline in Clinical laboratory tests
Time frame: up to 23 days post treatment
Occurrence of Adverse Events
Time frame: up to 23 days post treatment
Assessment of tolerability by investigator
Time frame: up to 23 days 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 United States.
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 25 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 United States. 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 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?
Individual time course profiles of 14C-radioactivity (in nmol eq/L or nmol eq/kg for faeces) in whole blood, plasma, urine, and faeces (time frame: up to 336 h post treatment). The study lists 7 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.