Table 1.
Overview of the Three Parts of the Phase-1 First-in-human Study on Flubentylosin.
Fig 1.
Patient Disposition in Phase-I Study on Flubentylosin.
Table 2.
Demographic Characteristics of Subjects in the Three Parts of the Phase-I Study on Flubentylosin.
Fig 2.
Mean Blood Flubentylosin Concentrations Versus Time Profiles after Single Oral Administration of Ascending Doses from 40 mg to 1000 mg (Part 1), Linear (top) and Log-linear (bottom) Scales.
Fig 3.
Mean Dose-normalized Cmax and AUC of Flubentylosin after Single Oral Administration of Ascending Doses from 40 mg to 1000 mg (Part 1).
Table 3.
Mean PK Parameters for Flubentylosin in Part 1 (Single Ascending Doses).
Fig 4.
Mean Blood Flubentylosin Concentrations versus Time Profiles after Administration of Flubentylosin 1000 mg under Fasting and Fed Conditions in Part 2 (Food Effect), Linear (top) and Log-linear (bottom) Scales.
Table 4.
Geometric Mean PK Parameters for Flubentylosin after Administration under Fasting and Fed Conditions in Part 2 (Food Effect).
Table 5.
Relative Bioavailability of Flubentylosin after Administration under Fasting and Fed Conditions in Part 2 (Food Effect).
Fig 5.
Mean Blood Flubentylosin Concentrations versus Time Profiles after Administration of Multiple Ascending Doses of Flubentylosin in Part 3 (Upper Panels Linear Scale—Lower Panels Log-Linear Scale)
Table 6.
Geometric Mean (Arithmetic Mean, % CV) PK Parameters for Flubentylosin after Administration of Multiple Ascending Doses in Part 3.
Table 7.
Treatment-emergent Adverse Events Reported with Flubentylosin in Part 1 (Single Ascending Doses), presented by System-organ Class.
Table 8.
Treatment-emergent Adverse Events Reported with Flubentylosin in Part 2 (Food Effect), presented by System-organ Class.
Table 9.
Treatment-emergent Adverse Events Reported with Flubentylosin in Part 3 (Multiple Ascending Doses), presented by System-organ Class.
Table 10.
Adverse Events Reported in the Phase-I Study.