Postmarketing requirement 5057-2 p-gp and BCRP substrate interaction trial

5 evidence topics · 1 source

Objective

Required trial and its purpose

“Conduct a clinical pharmacokinetic trial to assess a serious potential risk of increased drug toxicity by evaluating the effect of repeat doses of lirafugratinib on the single dose pharmacokinetics of a sensitive P-gp and BCRP substrate and inform appropriate management strategies for clinically relevant drug interactions.” (opens the source at this quote in a new tab)

Safety signal prompting the requirement

“to assess a signal of a serious risk of increased drug toxicity when lirafugratinib is used concomitantly with sensitive P-gp and BCRP substrates.” (opens the source at this quote in a new tab)

Location and study date

Timetable submitted by the sponsor

Milestone	Approval letter
Trial completion	“Trial Completion: 05/2032”
Final report submission	“Final Report Submission: 09/2032”

Registry record and trial sites

No evidence found.

Study design

Required design: repeat-dose lirafugratinib with a single-dose substrate

“evaluating the effect of repeat doses of lirafugratinib on the single dose pharmacokinetics of a sensitive P-gp and BCRP substrate” (opens the source at this quote in a new tab)

Eligibility criteria

No evidence found.

Treatment

No evidence found.

Study outcomes

Rationale for using substrate pharmacokinetics as the primary endpoint

No evidence found.

Statistical analysis description

Number of participants (Planned and analyzed)

No evidence found.

Description of analysis sets

No evidence found.

Results

Participant disposition

No evidence found.

Baseline characteristics

No evidence found.

Efficacy results

No evidence found.

Health-related quality of life and patient-reported outcomes

Not applicable.

Safety results

No evidence found.

Study limitations

Summary

The effect of repeated lirafugratinib dosing on a sensitive P-gp and BCRP substrate has not yet been studied clinically; the FDA required this trial because of a signal of increased toxicity with concomitant use, and the sponsor's timetable schedules completion for May 2032 and the final report for September 2032. No protocol, registry record, design, or sample size was located.