At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 19 enrolled
Drug / intervention
Drug Drug Interactiondrug
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 Single-centre, Open-label, Fixed-sequence Trial to Evaluate the Impact of C21 on the Exposure of CYP1A2, CYP2C9, CYP3A4 and P-gp Substrates in Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating Drug Drug Interaction for Drug Interaction. Completed, enrolled 19 participants across 1 site.
Detailed Summary
This is a single-centre, open-label, fixed-sequence trial to evaluate the impact of C21 on the exposure of CYP1A2, CYP2C9, CYP3A4 and P-gp substrates in healthy volunteers.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDrug Interaction
CountriesSweden
Collaborators--
Timeline
Phase 1CompletedFinished
202420252026
Enrollment StartMar 2023
First PostedApr 2023
Primary CompletionMay 2023
TodayJul 2026
First PostedApr 26, 2023
Enrollment StartMar 29, 2023
Primary CompletionMay 11, 2023
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 3.2 years ago
Interventions
Drug Drug Interactiondrug
The intervention phase consists of 3 periods: in period 1, the pharmacokinetics (PK) of all substrates will be evaluated in the absence of C21, in period 2, a potential inhibitory effect of C21 on the substrates be evaluated, and in period 3, the net effect of potential C21-mediated induction and inhibition on the substrates will be evaluated