HealthyPhase 1NCT02221388

Relative Bioavailability of Different Formulations of BI 671800 in Healthy Male and Female Volunteers

A Phase 1 study testing BI 671800 HEA, 200 mg tablets, BI 671800 HEA EC, 200 mg tablets and BI 671800 HEA, 50 mg tablets in people with Healthy, run by Boehringer Ingelheim.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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 HEA, 200 mg tablets, BI 671800 HEA EC, 200 mg tablets and BI 671800 HEA, 50 mg tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: No sites listed yet
Study dates: Feb 2010to Jul 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 (BP, PR), 12-lead ECG, clinical laboratory tests
Age 21 to 50 years (incl.)
BMI 18.5 to 29.9 kg/m2 (incl.)
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) 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
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 24Show fewer

Chronic or relevant acute infections
History of relevant allergy or 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
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)
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 aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyltransferase (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
Unwilling to avoid excessive sunlight exposure
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).
A marked baseline prolongation of the 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)
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

About this study

Official title: Relative Bioavailability of Different Salt Forms and Formulations of Single Doses Either 50 or 200 mg BI 671800 in the Fasted or Fed State. An Open-label, Randomised, Phase I Study With a 3-period Crossover Followed by Two Treatment Periods in Fixed Sequence in Healthy Male and Female Volunteers

To compare the oral bioavailability and rate of absorption of two different formulations of BI 671800 HEA (choline salt) tablets 200 mg, one with enteric coating (EC) and one without EC, versus 2 x 100 mg BI 671800 ED (ethylenediamine salt) capsules. Both BI 671800 HEA formulations were further investigated concerning food effect and one of the two BI 671800 HEA formulations identified by interim pharmacokinetic analysis was further investigated concerning dose proportionality with 50 mg.

Conditions: Healthy
Being tested: BI 671800 HEA, 200 mg tablets, BI 671800 HEA EC, 200 mg tablets, BI 671800 HEA, 50 mg tablets, BI 671800 ED, 100 mg capsules, Standard meal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BI 671800 HEA, 200 mg tabletsDrug
BI 671800 HEA EC, 200 mg tabletsDrug
BI 671800 HEA, 50 mg tabletsDrug
BI 671800 ED, 100 mg capsulesDrug
Standard mealOther

Study groups in NCT02221388
Study group	Role	What they receive
BI 671800 ED capsules	Active comparator	Not described Receives: Drug: BI 671800 ED, 100 mg capsules
BI 671800 HEA tablet in fasted state	Experimental	Not described Receives: Drug: BI 671800 HEA, 200 mg tablets
BI 671800 HEA EC tablet in fasted state	Experimental	Not described Receives: Drug: BI 671800 HEA EC, 200 mg tablets
BI 671800 HEA tablet in fed state	Experimental	Not described Receives: Drug: BI 671800 HEA, 200 mg tablets; Other: Standard meal
BI 671800 HEA EC tablet in fed state	Experimental	Not described Receives: Drug: BI 671800 HEA EC, 200 mg tablets; Other: Standard meal
BI 671800 HEA, 50 mg tablet in fasted state	Experimental	Not described Receives: Drug: BI 671800 HEA, 50 mg tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax (maximum measured concentration of BI 671800 in plasma)
Measured: Up to 24 hours after last drug administration
AUC0-∞ (area under the concentration time curve of BI 671800 in plasma over the time interval from 0 extrapolated to infinity)
Measured: Up to 24 hours after last drug administration

Secondary outcomes (13)

tmax (time from dosing to the maximum concentration of BI 671800 in plasma)
Measured: Up to 24 hours after last drug administration
AUC0-tz (area under the concentration-time curve of BI 671800 in plasma over the time interval from 0 to the time of the last quantifiable data point)
Measured: Up to 24 hours after drug administration
λz (terminal rate constant in plasma)
Measured: Up to 24 hours after drug adminnistration
t½ (terminal half-life of BI 671800 in plasma)
Measured: Up to 24 hours after drug administration
MRTpo (mean residence time of BI 671800 in the body after po administration)
Measured: Up to 24 hours after drug administration
CL/F (apparent clearance of BI 671800 in the plasma after extravascular administration)
Measured: Up to 24 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Measured: Up to 24 hours after drug administration
Number of patients with clinical significant findings in physical examinations
Measured: Up to 10 days after last drug admininstration
Number of patients with clinical significant findings in vital signs
Measured: Up to 10 days after last drug administration
Number of patients with clinical significant findings in ECG
Measured: Up to 10 days after last drug administration
Number of patients with clinical significant findings in laboratory tests
Measured: Up to 10 days after last drug administration
Number of patients with adverse events
Measured: Up to 10 days after last drug administration
Investigator assessed tolerability on a 4 point scale
Measured: Up to 10 days after last drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2010Jul 2010

First posted20 Aug 2014 (estimated)
Study startFeb 2010
Primary completionJul 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: Crossover
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02221388
Sponsor's protocol ID: 1268.56
Status last verified: Aug 2014
First submitted: 19 Aug 2014
Last updated: 20 Aug 2014
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Relative Bioavailability of Different Salt Forms and Formulations of Single Doses Either 50 or 200 mg BI 671800 in the Fasted or Fed State. An Open-label, Randomised, Phase I Study With a 3-period Crossover Followed by Two Treatment Periods in Fixed Sequence in Healthy Male and Female Volunteers
ClinicalTrials.gov ID: NCT02221388
Acronym / sponsor ID: 1268.56
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Feb 2010
Primary completion: Jul 2010 (actual)
First posted: 20 Aug 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
BI 671800 ED capsules	Active comparator	Drug: BI 671800 ED, 100 mg capsules
BI 671800 HEA tablet in fasted state	Experimental	Drug: BI 671800 HEA, 200 mg tablets
BI 671800 HEA EC tablet in fasted state	Experimental	Drug: BI 671800 HEA EC, 200 mg tablets
BI 671800 HEA tablet in fed state	Experimental	Drug: BI 671800 HEA, 200 mg tablets, Other: Standard meal
BI 671800 HEA EC tablet in fed state	Experimental	Drug: BI 671800 HEA EC, 200 mg tablets, Other: Standard meal
BI 671800 HEA, 50 mg tablet in fasted state	Experimental	Drug: BI 671800 HEA, 50 mg tablets

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 (BP, PR), 12-lead ECG, clinical laboratory tests
Age 21 to 50 years (incl.)
BMI 18.5 to 29.9 kg/m2 (incl.)
Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation

Key exclusion criteria (24 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
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 671800 HEA, 200 mg tablets	Drug	BI 671800 HEA tablet in fasted state, BI 671800 HEA tablet in fed state
BI 671800 HEA EC, 200 mg tablets	Drug	BI 671800 HEA EC tablet in fasted state, BI 671800 HEA EC tablet in fed state
BI 671800 HEA, 50 mg tablets	Drug	BI 671800 HEA, 50 mg tablet in fasted state
BI 671800 ED, 100 mg capsules	Drug	BI 671800 ED capsules
Standard meal	Other	BI 671800 HEA EC tablet in fed state, BI 671800 HEA tablet in fed state

Primary outcome

Cmax (maximum measured concentration of BI 671800 in plasma)
Time frame: Up to 24 hours after last drug administration
AUC0-∞ (area under the concentration time curve of BI 671800 in plasma over the time interval from 0 extrapolated to infinity)
Time frame: Up to 24 hours after last drug administration

13 secondary outcomes

tmax (time from dosing to the maximum concentration of BI 671800 in plasma)
Time frame: Up to 24 hours after last drug administration
AUC0-tz (area under the concentration-time curve of BI 671800 in plasma over the time interval from 0 to the time of the last quantifiable data point)
Time frame: Up to 24 hours after drug administration
λz (terminal rate constant in plasma)
Time frame: Up to 24 hours after drug adminnistration
t½ (terminal half-life of BI 671800 in plasma)
Time frame: Up to 24 hours after drug administration
MRTpo (mean residence time of BI 671800 in the body after po administration)
Time frame: Up to 24 hours after drug administration
CL/F (apparent clearance of BI 671800 in the plasma after extravascular administration)
Time frame: Up to 24 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: Up to 24 hours after drug administration
Number of patients with clinical significant findings in physical examinations
Time frame: Up to 10 days after last drug admininstration
Number of patients with clinical significant findings in vital signs
Time frame: Up to 10 days after last drug administration
Number of patients with clinical significant findings in ECG
Time frame: Up to 10 days after last drug administration
Number of patients with clinical significant findings in laboratory tests
Time frame: Up to 10 days after last drug administration
Number of patients with adverse events
Time frame: Up to 10 days after last drug administration
Investigator assessed tolerability on a 4 point scale
Time frame: Up to 10 days after last drug administration

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 20 Aug 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 671800 HEA, 200 mg tablets, BI 671800 HEA EC, 200 mg tablets and BI 671800 HEA, 50 mg tablets 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 24 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 20 Aug 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. 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?

Cmax (maximum measured concentration of BI 671800 in plasma) (time frame: Up to 24 hours after last drug administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02221388.

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 20 Aug 2014.