Phase 1
Completed N=32
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
Healthy
Source: ClinicalTrials.gov NCT01737996 ↗
Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcomePrimary: Number of Healthy Subjects With AEs (Multiple Rising Dose Part) — 6; 5 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Healthy Subjects With AEs (Multiple Rising Dose Part) |
6; 5 | — |
| PRIMARY AUC(0-12h) and AUC(0-12h,ss) of Deleobuvir (Combined Treatment Part) |
37500; 51400 | — |
| PRIMARY Cmax and Cmax,ss of Deleobuvir (Combined Treatment Part) |
6930; 9710 | — |
| PRIMARY C(12h) and C(12h,ss) of Deleobuvir (Combined Treatment Part) |
1090; 1000 | — |
| PRIMARY AUC(0-12h) and AUC(0-12h,ss) of CD 6168 (Combined Treatment Part) |
6080; 38100 | — |
| PRIMARY Cmax and Cmax,ss of CD 6168 (Combined Treatment Part) |
902; 4860 | — |
| PRIMARY C(12h) and C(12h,ss) of CD 6168 (Combined Treatment Part) |
488; 1650 | — |
| PRIMARY AUC(0-12h) and AUC(0-12h,ss) of BI 208333 (Combined Treatment Part) |
9130; 13600 | — |
| PRIMARY Cmax and Cmax,ss of BI 208333 (Combined Treatment Part) |
1450; 2060 | — |
| PRIMARY C(12h) and C(12h,ss) of BI 208333 (Combined Treatment Part) |
520; 447 | — |
| PRIMARY AUC(0-12h) and AUC(0-12h,ss) of CD 6168 Acylglucuronide (Combined Treatment Part) |
511; 3560 | — |
| PRIMARY Cmax and Cmax,ss of CD 6168 Acylglucuronide (Combined Treatment Part) |
83.9; 457.0 | — |
| PRIMARY C(12h) and C(12h,ss) of CD 6168 Acylglucuronide (Combined Treatment Part) |
56.4; 178.0 | — |
| PRIMARY AUC(0-24h) and AUC(0-24h,ss) of Faldaprevir (Combined Treatment Part) |
44800; 66200 | — |
| PRIMARY Cmax and Cmax,ss of Faldaprevir (Combined Treatment Part) |
4060.0; 5940.0 | — |
| SECONDARY AUC(0-12h) and AUC(0-12h,ss) of Deleobuvir (Multiple Rising Dose Part) |
8210; 18000; 6160; 18500 | — |
| SECONDARY Cmax and Cmax,ss of Deleobuvir (Multiple Rising Dose Part) |
2010; 3740; 1380; 3650 | — |
| SECONDARY AUC(0-12h) and AUC(0-12h,ss) of CD 6168 (Multiple Rising Dose Part) |
1690; 2920; 2810; 6960 | — |
| SECONDARY Cmax and Cmax,ss of CD 6168 (Multiple Rising Dose Part) |
329; 516; 451; 1130 | — |
| SECONDARY AUC(0-12h) and AUC(0-12h,ss) of BI 208333 (Multiple Rising Dose Part) |
3940; 6060; 2840; 5270 | — |
| SECONDARY Cmax and Cmax,ss of BI 208333 (Multiple Rising Dose Part) |
766; 1050; 576; 983 | — |
| SECONDARY AUC(0-12h) and AUC(0-12h,ss) of CD 6168 Acylglucuronide (Multiple Rising Dose Part) |
155; 342; 256; 701 | — |
| SECONDARY Cmax and Cmax,ss of CD 6168 Acylglucuronide (Multiple Rising Dose Part) |
27.3; 57.9; 33.3; 116.0 | — |
Eligibility Criteria
Inclusion criteria
- healthy male and female subjects
Exclusion criteria
- Any relevant deviation from healthy conditions
Data sourced from ClinicalTrials.gov (NCT01737996). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.