Safety, Tolerability and Pharmacokinetics of Different Multiple Doses of BI 207127 BID and Multiple Doses of BI 207127 Combined With Faldaprevir in Healthy Male and Female Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 207127 + faldaprevir

• Registration Number: NCT01737996
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The objective of the current trial is to evaluate safety, tolerability and pharmacokinetics of different multiple doses of BI 207127 BID and multiple doses of BI 207127 combined with faldaprevir in healthy male and female subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-26
• Study First Submitted QC: 2012-11-28
• Study First Posted: 2012-11-30
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Results First Submitted: 2016-01-21
• Status Verified: 2016-03
• Results First Submitted QC: 2016-03-10
• Last Update Submitted: 2016-03-10
• Results First Posted: 2016-04-08
• Last Update Posted: 2016-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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
All patients	BI 207127 + faldaprevir	For the first 9 days patients receive BI 207127 low dose or high dose, then BI 207127 high dose with faldaprevir

Primary Outcome Measures

Name	Time	Method
Number of Healthy Subjects With AEs (Multiple Rising Dose Part)	From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)	Number of healthy subjects with any adverse event (AE) during the on-treatment period.
Cmax and Cmax,ss of CD 6168 (Combined Treatment Part)	After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.	Maximum measured concentration of CD 6168 on Day 1 and at steady state on Day 16.; CD 6168 is a major metabolite of Deleobuvir.
Cmax and Cmax,ss of BI 208333 (Combined Treatment Part)	After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.	Maximum measured concentration of BI 208333 on Day 1 and at steady state on Day 16.; BI 208333 is a major metabolite of Deleobuvir.
Cmax and Cmax,ss of CD 6168 Acylglucuronide (Combined Treatment Part)	After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.	Maximum measured concentration of CD 6168 acylglucuronide on Day 1 and at steady state on Day 16.; CD 6168 acylglucuronide is a metabolite of Deleobuvir.
AUC(0-24h) and AUC(0-24h,ss) of Faldaprevir (Combined Treatment Part)	After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.	Area under the concentration-time curve of Faldaprevir over the uniform dosing interval 0 to 24 h on Day 1 and at steady state on Day 16.
C(12h) and C(12h,ss) of BI 208333 (Combined Treatment Part)	After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.	Concentration of BI 208333 at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.; BI 208333 is a major metabolite of Deleobuvir.
AUC(0-12h) and AUC(0-12h,ss) of Deleobuvir (Combined Treatment Part)	After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 hours (h) after drug administration in the morning.	Area under the concentration-time curve (AUC) of Deleobuvir over the uniform dosing interval 0 to 12 h (hours) on Day 1 and at steady state on Day 16.
Cmax and Cmax,ss of Deleobuvir (Combined Treatment Part)	After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.	Maximum measured concentration of Deleobuvir on Day 1 and at steady state on Day 16.
AUC(0-12h) and AUC(0-12h,ss) of CD 6168 (Combined Treatment Part)	After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.	Area under the concentration-time curve of CD 6168 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.; CD 6168 is a major metabolite of Deleobuvir.
AUC(0-12h) and AUC(0-12h,ss) of BI 208333 (Combined Treatment Part)	After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.	Area under the concentration-time curve of BI 208333 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.; BI 208333 is a major metabolite of Deleobuvir.
C(12h) and C(12h,ss) of CD 6168 Acylglucuronide (Combined Treatment Part)	After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.	Concentration of CD 6168 acylglucuronide at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.; CD 6168 acylglucuronide is a metabolite of Deleobuvir.
Cmax and Cmax,ss of Faldaprevir (Combined Treatment Part)	After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12, 24 h after drug administration in the morning.	Maximum measured concentration of Faldaprevir on Day 1 and at steady state on Day 16.
C(12h) and C(12h,ss) of Deleobuvir (Combined Treatment Part)	After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.	Concentration of Deleobuvir at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.
C(12h) and C(12h,ss) of CD 6168 (Combined Treatment Part)	After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.	Concentration of CD 6168 at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.; CD 6168 is a major metabolite of Deleobuvir.
AUC(0-12h) and AUC(0-12h,ss) of CD 6168 Acylglucuronide (Combined Treatment Part)	After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.	Area under the concentration-time curve of CD 6168 acylglucuronide over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.; CD 6168 acylglucuronide is a metabolite of Deleobuvir.

Secondary Outcome Measures

Name	Time	Method
AUC(0-12h) and AUC(0-12h,ss) of CD 6168 Acylglucuronide (Multiple Rising Dose Part)	After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.	Area under the concentration-time curve of CD 6168 acylglucuronide over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 9.; CD 6168 acylglucuronide is a metabolite of Deleobuvir.
AUC(0-12h) and AUC(0-12h,ss) of BI 208333 (Multiple Rising Dose Part)	After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.	Area under the concentration-time curve of BI 208333 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 9.; BI 208333 is a major metabolite of Deleobuvir.
Cmax and Cmax,ss of Deleobuvir (Multiple Rising Dose Part)	After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.	Maximum measured concentration of Deleobuvir on Day 1 and at steady state on Day 9.
Cmax and Cmax,ss of CD 6168 (Multiple Rising Dose Part)	After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.	Maximum measured concentration of CD 6168 on Day 1 and at steady state on Day 9.; CD 6168 is a major metabolite of Deleobuvir.
Cmax and Cmax,ss of BI 208333 (Multiple Rising Dose Part)	After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.	Maximum measured concentration of BI 208333 on Day 1 and at steady state on Day 9.; BI 208333 is a major metabolite of Deleobuvir.
AUC(0-12h) and AUC(0-12h,ss) of CD 6168 (Multiple Rising Dose Part)	After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.	Area under the concentration-time curve of CD 6168 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 9.; CD 6168 is a major metabolite of Deleobuvir.
Cmax and Cmax,ss of CD 6168 Acylglucuronide (Multiple Rising Dose Part)	After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.	Maximum measured concentration of CD 6168 acylglucuronide on Day 1 and at steady state on Day 9.; CD 6168 acylglucuronide is a metabolite of Deleobuvir.
AUC(0-12h) and AUC(0-12h,ss) of Deleobuvir (Multiple Rising Dose Part)	After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.	Area under the concentration-time curve of Deleobuvir over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 9.

Trial Locations

Locations (1)

1241.35.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Mannheim, Germany