Relative Bioavailability of BI 671800 HEA in Healthy Male Volunteers

NCT02222233 | Completed Phase 1

• 1 other identifier: 1268.60
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• AUC0-∞ (area under the concentration-time curve of BI 671800 in plasma over the time interval from 0 extrapolated to infinity)

  Up to 24 hours after last drug administration

Secondary Outcomes (14)

• 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

• 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

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

  Up to 24 hours after drug administration

Study Arms (5)

BI 671800 HEA delayed release (enteric coated) tablet

EXPERIMENTAL

Drug: BI 671800 HEA delayed release (enteric coated) tablet

BI 671800 HEA solution released in jejunum

EXPERIMENTAL

BI 671800 HEA solution in the Enterion® capsule released in the jejunum

Drug: BI 671800 HEA solution

BI 671800 HEA solution released in ascending colon

EXPERIMENTAL

BI 671800 HEA solution in the Enterion® capsule released in the ascending colon

Drug: BI 671800 HEA solution

BI 671800 HEA solution released in descending colon

EXPERIMENTAL

BI 671800 HEA solution in the Enterion® capsule released in the descending colon

Drug: BI 671800 HEA solution

BI 671800 HEA particulate released in ascending colon

EXPERIMENTAL

BI 671800 HEA as particulate in the Enterion® capsule released in the ascending colon

Drug: BI 671800 HEA particulate

Interventions

BI 671800 HEA delayed release (enteric coated) tablet DRUG

BI 671800 HEA delayed release (enteric coated) tablet

BI 671800 HEA solution DRUG

BI 671800 HEA solution released in ascending colon; BI 671800 HEA solution released in descending colon; BI 671800 HEA solution released in jejunum

BI 671800 HEA particulate DRUG

BI 671800 HEA particulate released in ascending colon

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Tablets

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2014
• First Posted: August 21, 2014
• Study Start: January 1, 2010
• Primary Completion: March 1, 2010
• Last Updated: August 21, 2014

Record last verified: 2014-08