2.1 Trial design and subjects
This single-center, open-label, phase I trial was designed to primarily
assess the effect of multiple oral doses of rifampin on the
pharmacokinetics of a single oral dose of SHR2554 in healthy Chinese
volunteers. Secondly, we assessed the tolerance and safety of the
SHR2554 administration alone and when coadministration with rifampin in
Chinese healthy volunteers.
The subjects enrolled should age 18 to 45 years (including both ends)
with body mass index (BMI) in the range of 19.0-26.0
kg/m2 (including the critical value), the body weight
of male subjects less than 50 kg or that of female subjects less than 45
kg would be excluded. All inclusion and exclusion criteria were provided
in the supplementary.
The qualified subjects were admitted to the phase I clinical trial
center on D-0, provided light dinner, and fasted but no water for 10
hours. On D1, the subjects were orally administrated SHR2554 at a dose
of 300mg; then, all subjects were orally administrated rifampin 600mg
quaque die (QD) for 8 days (D4-D9, D12). On D-11, 300mg SHR2554 and
600mg rifampin were orally co-administrated under fasting conditions
with 240ml water. Water was forbidden before or after 1 hour, and food
was forbidden after 4 hours of administration. The blood samples were
collected before administration 60 mins, and
0.5h,1.0h,1.5h,2.0h,2.5h,3.0h,4.0h,6.0h,8.0h,12.0h,24.0h,48.0h
after first SHR2554 administration on day 1 and day 11. All subjects
were discharged after examination on D-13 and received follow-up visits
on D-16 to D-19. The clinical progress is shown in Figure 1 .
The study was conducted in accordance with the Declaration of Helsinki
and Good Clinical Practice (GCP) and approved by the Institutional
Ethics Committee of Xiangya Hospital. Written informed consent was
obtained from all subjects prior to the screening. This study was
registered at