At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 17 enrolled
Drug / intervention
SHR8554；Itraconazoledrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1, Open-label, Fixed-sequence Study to Estimate the Effects of Multiple-dose Administration of Itraconazole on the Pharmacokinetics of SHR8554 in Healthy Adult Subjects
In Brief
A Phase 1 clinical trial evaluating SHR8554；Itraconazole for Healthy. Completed, enrolled 17 participants across 1 site.
Detailed Summary
This drug-drug interaction (DDI) study has been designed to characterize the pharmacokinetic profile of SHR8554 when co administered with a strong cytochrome P450 3A4 (CYP3A4) inhibitor itraconazole
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesChina
Collaborators--
Timeline
Phase 1CompletedFinished
20222023202420252026
Enrollment StartJan 2022
Primary CompletionJan 2022
Study CompletionJun 2022
First PostedJul 2023
TodayJul 2026
First PostedJul 3, 2023
Enrollment StartJan 4, 2022
Primary CompletionJan 21, 2022
Study CompletionJun 9, 2022
TodayJul 2, 2026
Enrollment to primary: 17 daysPosted 3.0 years ago
Interventions
SHR8554；Itraconazoledrug
Drug: SHR8554 Administered as specified in the treatment arm Drug: Itraconazole Administered as specified in the treatment arm