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

NCT01205373 | Completed Phase 1

• 2 other identifiers: 1268.72009-016370-32
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (7)

• Individual time course profiles of 14C-radioactivity (in nmol eq/L or nmol eq/kg for faeces) in whole blood, plasma, urine, and faeces

  up to 336 h post treatment

• Individual time course profiles of BI 671800 and its major metabolite CD6384 in plasma and urine

  up to 336 h post treatment

• Rate and extent of excretion mass balance based on the total radioactivity in urine and faeces

  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)

  up to 336 h post treatment

• Cblood cells/Cplasma ratio of 14C-radioactivity

  up to 168 h post treatment

• concentrations of BI 671800 and its metabolite CD6384 in plasma and urine

  up to 336 h post treatment

• concentrations of 14C-radioactivity in whole blood, plasma, urine, and faeces

  up to 336 h post treatment

Secondary Outcomes (7)

• Changes from Baseline in Vital signs (pulse rate)

  up to 23 days post treatment

• Changes from Baseline in Physical examination

  up to 23 days post treatment

• Changes from Baseline in Vital signs (blood pressure)

  up to 23 days post treatment

• Changes from Baseline in 12-lead electrocardiogram (ECG)

  up to 23 days post treatment

• Changes from Baseline in Clinical laboratory tests

  up to 23 days post treatment

Study Arms (1)

BI 671800 high dose

EXPERIMENTAL

Oral drinking solution

Drug: BI 671800

Interventions

BI 671800 DRUG

High dose oral drinking solution

BI 671800 high dose

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1268.7.001 Boehringer Ingelheim Investigational Site

Madison, Wisconsin, United States

Location

MeSH Terms

Interventions

BI 671800

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 17, 2010
• First Posted: September 20, 2010
• Study Start: September 1, 2010
• Primary Completion: October 1, 2010
• Last Updated: November 1, 2013

Record last verified: 2013-10

Locations

US (1)