- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01205373
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
October 31, 2013 updated by: Boehringer Ingelheim
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States
- 1268.7.001 Boehringer Ingelheim Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion criteria:
- 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
Exclusion criteria:
- 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
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: BI 671800 high dose
Oral drinking solution
|
High dose oral drinking solution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
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
|
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
|
up to 336 h post treatment
|
Cblood cells/Cplasma ratio of 14C-radioactivity
Time Frame: up to 168 h post treatment
|
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
|
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
|
up to 336 h post treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes from Baseline in Vital signs (pulse rate)
Time Frame: up to 23 days post treatment
|
up to 23 days post treatment
|
Changes from Baseline in Physical examination
Time Frame: up to 23 days post treatment
|
up to 23 days post treatment
|
Changes from Baseline in Vital signs (blood pressure)
Time Frame: up to 23 days post treatment
|
up to 23 days post treatment
|
Changes from Baseline in 12-lead electrocardiogram (ECG)
Time Frame: up to 23 days post treatment
|
up to 23 days post treatment
|
Changes from Baseline in Clinical laboratory tests
Time Frame: up to 23 days post treatment
|
up to 23 days post treatment
|
Occurrence of Adverse Events
Time Frame: up to 23 days post treatment
|
up to 23 days post treatment
|
Assessment of tolerability by investigator
Time Frame: up to 23 days post treatment
|
up to 23 days post treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (ACTUAL)
October 1, 2010
Study Registration Dates
First Submitted
September 17, 2010
First Submitted That Met QC Criteria
September 17, 2010
First Posted (ESTIMATE)
September 20, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
November 1, 2013
Last Update Submitted That Met QC Criteria
October 31, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- 1268.7
- 2009-016370-32 (EUDRACT_NUMBER: EudraCT)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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