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Completed

NCT Number: NCT01737996

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

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.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

1241.35.1 Boehringer Ingelheim Investigational Site

Mannheim, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy male and female subjects

Exclusion criteria

  • Any relevant deviation from healthy conditions

Treatment and study plan

BI 207127 + faldaprevir

Drug

fixed dose combination

Primary outcomes

  1. Number of Healthy Subjects With AEs (Multiple Rising Dose Part)

    Time frame: 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.

  2. AUC(0-12h) and AUC(0-12h,ss) of Deleobuvir (Combined Treatment Part)

    Time frame: 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.

  3. Cmax and Cmax,ss of Deleobuvir (Combined Treatment Part)

    Time frame: 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.

  4. C(12h) and C(12h,ss) of Deleobuvir (Combined Treatment Part)

    Time frame: 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.

  5. AUC(0-12h) and AUC(0-12h,ss) of CD 6168 (Combined Treatment Part)

    Time frame: 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.

  6. Cmax and Cmax,ss of CD 6168 (Combined Treatment Part)

    Time frame: 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.

  7. C(12h) and C(12h,ss) of CD 6168 (Combined Treatment Part)

    Time frame: 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.

  8. AUC(0-12h) and AUC(0-12h,ss) of BI 208333 (Combined Treatment Part)

    Time frame: 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.

  9. Cmax and Cmax,ss of BI 208333 (Combined Treatment Part)

    Time frame: 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.

  10. C(12h) and C(12h,ss) of BI 208333 (Combined Treatment Part)

    Time frame: 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.

  11. AUC(0-12h) and AUC(0-12h,ss) of CD 6168 Acylglucuronide (Combined Treatment Part)

    Time frame: 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.

  12. Cmax and Cmax,ss of CD 6168 Acylglucuronide (Combined Treatment Part)

    Time frame: 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.

  13. C(12h) and C(12h,ss) of CD 6168 Acylglucuronide (Combined Treatment Part)

    Time frame: 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.

  14. AUC(0-24h) and AUC(0-24h,ss) of Faldaprevir (Combined Treatment Part)

    Time frame: 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.

  15. Cmax and Cmax,ss of Faldaprevir (Combined Treatment Part)

    Time frame: 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.

Secondary outcomes

  1. AUC(0-12h) and AUC(0-12h,ss) of Deleobuvir (Multiple Rising Dose Part)

    Time frame: 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.

  2. Cmax and Cmax,ss of Deleobuvir (Multiple Rising Dose Part)

    Time frame: 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.

  3. AUC(0-12h) and AUC(0-12h,ss) of CD 6168 (Multiple Rising Dose Part)

    Time frame: 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.

  4. Cmax and Cmax,ss of CD 6168 (Multiple Rising Dose Part)

    Time frame: 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.

  5. AUC(0-12h) and AUC(0-12h,ss) of BI 208333 (Multiple Rising Dose Part)

    Time frame: 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.

  6. Cmax and Cmax,ss of BI 208333 (Multiple Rising Dose Part)

    Time frame: 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.

  7. AUC(0-12h) and AUC(0-12h,ss) of CD 6168 Acylglucuronide (Multiple Rising Dose Part)

    Time frame: 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.

  8. Cmax and Cmax,ss of CD 6168 Acylglucuronide (Multiple Rising Dose Part)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

An Open-label, Multiple Dose Study to Assess Safety, Tolerability and Pharmacokinetics of Different Multiple Doses of BI 207127 BID Administered Orally for 9 Days (Part 1) and Multiple Doses of BI 207127 Combined With Faldaprevir Administered Orally for 16 Days (Part 2) in Healthy Male and Female Subjects

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 30, 2012
Registry last updated
Apr 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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