Study Evaluating Absorption, Distribution, Metabolism and Excretion (ADME) of Single Dose [14C]-BI 207127 in Healthy Male Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 207127 NA

• Registration Number: NCT01605461
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Phase 1 study to assess the pharmacokinetics and routes of elimination of a single oral dose of \[14C\]-BI 207127 and to characterize the metabolic profile following single dose administration.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-09
• Study First Submitted QC: 2012-05-21
• Study First Posted: 2012-05-25
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Results First Submitted: 2016-01-21
• Status Verified: 2016-02
• Results First Submitted QC: 2016-02-22
• Last Update Submitted: 2016-02-22
• Results First Posted: 2016-03-21
• Last Update Posted: 2016-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BI 207127 NA	BI 207127 NA	Single oral solution dose of BI 207127 NA combined with \[14C\]-BI 207127 NA

Primary Outcome Measures

Name	Time	Method
AUC0-infinity of Plasma Deleobuvir	15 minutes (min) before drug administration and 30min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h, 72h and 96h after drug administration	Area under the plasma deleobuvir concentration-time curve over the time interval from 0 h extrapolated to infinity (AUC0-infinity)
Cmax of Plasma Deleobuvir	15 minutes (min) before drug administration and 30min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h, 72h and 96h after drug administration	Maximum measured concentration (Cmax) of plasma deleobuvir
Excretion Balance of Total [14C]-Radioactivity	Before drug administration (24hours (h) to 15 minutes pre-dose) and 0h-24h, 24h-48h, 48h-72h, 72h-96h, 96h-120h, 120h-144h, 144h-168h, 168h-192h and 192h-216h after drug administration	Excretion balance of total \[14C\]-radioactivity (urine and faeces)
t1/2 of [14C]-Radioactivity in Plasma	15 minutes (min) before drug administration and 30min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h, 72h and 96h after drug administration	Terminal half life (T1/2) of \[14C\]-radioactivity in plasma
Excretion of Total [14C]-Radioactivity in Urine	Before drug administration (24hours (h) to 15 minutes pre-dose) and 0h-24h, 24h-48h, 48h-72h, 72h-96h, 96h-120h, 120h-144h, 144h-168h, 168h-192h and 192h-216h after drug administration	Excretion of total \[14C\]-radioactivity in urine
Excretion of Total [14C]-Radioactivity in Faeces	Before drug administration (24hours (h) to 15 minutes pre-dose) and 0h-24h, 24h-48h, 48h-72h, 72h-96h, 96h-120h, 120h-144h, 144h-168h, 168h-192h and 192h-216h after drug administration	Excretion of total \[14C\]-radioactivity in faeces

Trial Locations

Locations (1)

1241.22.001 Boehringer Ingelheim Investigational Site; 🇺🇸 Madison, Wisconsin, United States