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HealthyPhase 1NCT02222233

Relative Bioavailability of BI 671800 HEA in Healthy Male Volunteers

A Phase 1 study testing BI 671800 HEA delayed release (enteric coated) tablet, BI 671800 HEA solution and BI 671800 HEA particulate 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

To determine the relative bioavailability of single doses of 200 mg BI 671800 HEA (choline) administered as a delayed release (enteric coated) tablet; or via the EnterionTM capsule as solution to the jejunum, ascending or descending colon, or as particulate to the ascending colon Read more about this study

Who is it for?
Ages 21 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
BI 671800 HEA delayed release (enteric coated) tablet, BI 671800 HEA solution and BI 671800 HEA particulate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
No sites listed yet
Study dates
Jan 2010to Mar 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 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy males subjects
  • Aged 21-65 years
  • Body Mass Index (BMI) of 18.5-29.9 kg/m2 inclusive
  • Subjects must demonstrate their ability to swallow an empty size 000 capsule
  • Must be willing and able to participate in the whole study and must provide written informed consent

Who cannot join

  • Participation in a clinical research study involving investigational drugs or dosage forms within the previous 3 months
  • Subjects who have previously been enrolled in this study
  • Subjects who have ever sought advice from or been referred to a general practitioner or counsellor for abuse or misuse of alcohol, non medical drugs, medicinal drugs or other substance abuse e.g. solvents
  • Subjects who admit to any current or previous use of Class A drugs such as opiates, cocaine, ecstasy, lysergic acid diethylamide (LSD) and intravenous amphetamines (Subjects who admit to occasional past use of cannabis will not be excluded as long as they have a negative drugs of abuse test and have been abstinent for at least 12 months)
  • Positive drugs of abuse test result
  • Regular alcohol consumption >21 units per week (1 Unit = ½ pint beer, a 25 mL shot of 40% spirit or a 125 mL glass of wine)
Show all 23Show fewer
  • Current smokers and those who have smoked within the last 6 months. A breath carbon monoxide reading of greater than 10 ppm at screening
  • Radiation exposure from clinical trials, including that from the present study, excluding background radiation but including diagnostic X-rays and other medical exposures, exceeding 5 millisievert (mSv) in the last twelve months or 10 mSv in the last five years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study.
  • Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the Investigator, repeated alanine aminotransferase (ALT), aspartame aminotransferase (AST), gamma-glutamyltransferase (GGT), alkaline phosphatase (ALP) or Total bilirubin above upper limit normal (ULN)
  • History of gastrointestinal surgery (with the exception of appendectomy unless it was performed within the previous 12 months)
  • History of clinically significant disease such as cardiovascular, renal, hepatic, respiratory, central nervous system (CNS), metabolic and particularly gastrointestinal disease, especially peptic ulceration, gastrointestinal bleeding, ulcerative colitis, Crohn's Disease or Irritable Bowel Syndrome
  • History of adverse reaction or allergy to study drug or its excipients, e.g. lactose or rescue medication (if specified by the Sponsor). If subject suffers from hayfever they must not have or be expecting to have symptoms during the study period
  • Acute diarrhoea or constipation in the 7 days before the predicted first study day. If screening occurs >7 days before the first study day, this criterion will be determined on first study day. Diarrhoea will be defined as the passage of liquid faeces and/or a stool frequency of greater than three times per day. Constipation will be defined as a failure to open the bowels more frequently than every other day
  • Donation of blood or significant blood loss within the previous three months
  • Presence of non-removable metal objects such as metal plates, screws, etc, in the abdominal region of the body (with the exception of sterilisation clips)
  • Subjects will be excluded from the study if they are considered by the Investigator to be at risk of transmitting, through blood or other body fluids, the agents responsible for acquired immunodeficiency syndrome (AIDS) or other sexually transmitted disease or hepatitis
  • Positive hepatitis B (HBV), hepatitis C (HCV) or HIV results
  • Subjects receiving prohibited medication as described in Section 4.2
  • Unwilling to avoid excessive sunlight exposure
  • Failure to satisfy the Investigator of fitness to participate for any other reason
  • 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 QT/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)

About this study

Official title: Relative Bioavailability of Single Doses of 200 mg BI 671800 HEA Administered Orally as a Delayed Release (Enteric Coated) Tablet; or Via the EnterionTM Capsule as Solution to the Jejunum, Ascending Colon or Descending Colon; or Via the EnterionTM Capsule as Particulate to the Ascending Colon. An Open-label, Five Periods, Fixed Sequence Phase I Study in Healthy Male Volunteers

To determine the relative bioavailability of single doses of 200 mg BI 671800 HEA (choline) administered as a delayed release (enteric coated) tablet; or via the EnterionTM capsule as solution to the jejunum, ascending or descending colon, or as particulate to the ascending colon

Conditions
Healthy
Being tested
BI 671800 HEA delayed release (enteric coated) tablet, BI 671800 HEA solution, BI 671800 HEA particulate

What participants receive

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

  • BI 671800 HEA delayed release (enteric coated) tabletDrug

  • BI 671800 HEA solutionDrug

  • BI 671800 HEA particulateDrug

Study groups in NCT02222233
Study groupRoleWhat they receive
BI 671800 HEA delayed release (enteric coated) tabletExperimentalNot described
Receives: Drug: BI 671800 HEA delayed release (enteric coated) tablet
BI 671800 HEA solution released in jejunumExperimentalBI 671800 HEA solution in the Enterion® capsule released in the jejunum
Receives: Drug: BI 671800 HEA solution
BI 671800 HEA solution released in ascending colonExperimentalBI 671800 HEA solution in the Enterion® capsule released in the ascending colon
Receives: Drug: BI 671800 HEA solution
BI 671800 HEA solution released in descending colonExperimentalBI 671800 HEA solution in the Enterion® capsule released in the descending colon
Receives: Drug: BI 671800 HEA solution
BI 671800 HEA particulate released in ascending colonExperimentalBI 671800 HEA as particulate in the Enterion® capsule released in the ascending colon
Receives: Drug: BI 671800 HEA particulate

What is being measured

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

  1. 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 (14)

  1. 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

  2. tmax (time from dosing to the maximum concentration of BI 671800 in plasma)

    Measured: Up to 24 hours after drug administration

  3. Cmax (the maximum concentration of BI 671800 in plasma)

    Measured: Up to 24 hours after drug administration

  4. λz (terminal rate constant in plasma)

    Measured: Up to 24 hours after drug administration

  5. t½ (terminal half-life of BI 671800 in plasma)

    Measured: Up to 24 hours after drug administration

  6. MRTpo (mean residence time of BI 671800 in the body after oral administration)

    Measured: Up to 24 hours after drug administration

  7. CL/F (apparent clearance of BI 671800 in the plasma after extravascular administration)

    Measured: Up to 24 hours after drug administration

  8. Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)

    Measured: Up to 24 hours after drug administration

  9. tlag (time to first quantifiable plasma concentration)

    Measured: Up to 24 hours after drug administration

  10. Number of patients with clinical significant findings in physical examination

    Measured: Up to 10 days after last drug administration

  11. Number of patients with clinical significant findings in vital signs

    Measured: Up to 10 days after last drug administration

  12. Number of patients with clinical significant findings in 12-lead electrocardiogram (ECG)

    Measured: Up to 10 days after last drug administration

  13. Number of patients with clinical significant findings in clinical laboratory tests

    Measured: Up to 10 days after last drug administration

  14. Number of patients with adverse events

    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.

  1. First posted21 Aug 2014 (estimated)
  2. Study startJan 2010
  3. Primary completionMar 2010

Resources

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
Crossover
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02222233
Sponsor's protocol ID
1268.60
Status last verified
Aug 2014
First submitted
20 Aug 2014
Last updated
21 Aug 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 671800 HEA delayed release (enteric coated) tablet, BI 671800 HEA solution and BI 671800 HEA particulate 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 5 inclusion and 23 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 21 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?

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). 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 NCT02222233.

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 21 Aug 2014.

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