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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 671800

• Registration Number: NCT01205373
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-17
• Study First Submitted QC: 2010-09-17
• Study First Posted: 2010-09-20
• Primary Completion: 2010-10
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-31
• Last Update Posted: 2013-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BI 671800 high dose	BI 671800	Oral drinking solution

Primary Outcome Measures

Name	Time	Method
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
concentrations of 14C-radioactivity in whole blood, plasma, urine, and faeces	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
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
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

Secondary Outcome Measures

Name	Time	Method
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
Assessment of tolerability by investigator	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
Occurrence of Adverse Events	up to 23 days post treatment

Trial Locations

Locations (1)

1268.7.001 Boehringer Ingelheim Investigational Site; 🇺🇸 Madison, Wisconsin, United States