drugset
drugset / Trial / NCT07210996

A Study to Evaluate the Relative Bioavailability of Pimicotinib Capsules Containing Free Base in Different Proportions in Healthy Subjects

NCT07210996 ↗

Phase 1 Completed 20 enrolled Abbisko Therapeutics Co, Ltd
RandomizedCrossoverOpen-labelOther

Summary

This is an open-label, randomized, two-treatment, single-dose, two-way crossover study to evaluate the relative bioavailability and tolerability of Pimicotinib capsules containing free base in different proportions in healthy participants. 20 healthy participants are planned to be enrolled and will be evenly randomized to either Study Sequence A or Study Sequence B.Subjects in Sequence A/Sequence B will receive a single 50 mg oral dose of test/reference pimicotinib in period 1 and cross over in period 2. Blood samples will be collected for PK analysis in totally 32 time-points.

Timeline

Start
2025-09-12
Primary completion
2025-10-06
Completion
2025-10-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Pimicotinib Small molecule 50 mg Oral

Indications

No indication recorded.