NCT02222233
Completed
Phase 1
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
ConditionsHealthy
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 10
- Primary Endpoint
- AUC0-∞ (area under the concentration-time curve of BI 671800 in plasma over the time interval from 0 extrapolated to infinity)
Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 65 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
- •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)
Arms & Interventions
BI 671800 HEA delayed release (enteric coated) tablet
Experimental
Intervention: BI 671800 HEA delayed release (enteric coated) tablet (Drug)
BI 671800 HEA solution released in jejunum
Experimental
BI 671800 HEA solution in the Enterion® capsule released in the jejunum
Intervention: BI 671800 HEA solution (Drug)
BI 671800 HEA solution released in ascending colon
Experimental
BI 671800 HEA solution in the Enterion® capsule released in the ascending colon
Intervention: BI 671800 HEA solution (Drug)
BI 671800 HEA solution released in descending colon
Experimental
BI 671800 HEA solution in the Enterion® capsule released in the descending colon
Intervention: BI 671800 HEA solution (Drug)
BI 671800 HEA particulate released in ascending colon
Experimental
BI 671800 HEA as particulate in the Enterion® capsule released in the ascending colon
Intervention: BI 671800 HEA particulate (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Cmax (the maximum concentration of BI 671800 in plasma)(Up to 24 hours after drug administration)
- λz (terminal rate constant in plasma)(Up to 24 hours after drug administration)
- CL/F (apparent clearance of BI 671800 in the plasma after extravascular administration)(Up to 24 hours after drug administration)
- Number of patients with clinical significant findings in 12-lead electrocardiogram (ECG)(Up to 10 days after last drug administration)
- Number of patients with adverse events(Up to 10 days after last drug administration)
- t½ (terminal half-life of BI 671800 in plasma)(Up to 24 hours after drug administration)
- MRTpo (mean residence time of BI 671800 in the body after oral administration)(Up to 24 hours after drug administration)
- Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)(Up to 24 hours after drug administration)
- Number of patients with clinical significant findings in clinical laboratory tests(Up to 10 days 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)(Up to 24 hours after drug administration)
- tmax (time from dosing to the maximum concentration of BI 671800 in plasma)(Up to 24 hours after drug administration)
- tlag (time to first quantifiable plasma concentration)(Up to 24 hours after drug administration)
- Number of patients with clinical significant findings in vital signs(Up to 10 days after last drug administration)
- Number of patients with clinical significant findings in physical examination(Up to 10 days after last drug administration)
Investigators
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