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A Study to Investigate The Effect of Pimicotinib on The Pharmacokinetics of Metformin, Fexofenadine and Rosuvastatin In Healthy Subjects

NCT06779253 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2025-06-26

No results posted yet for this study

Summary

This is a an open-label, fixed-sequence DDI study conducted in Chinese healthy subjects to investigate the effect of multiple oral doses of pimicotinib on the pharmacokinetics of fexofenadine , rosuvastatin and metformin . Fexofenadine and rosuvastatin will be administered together as a cocktail, and metformin will be given via staggered dosing from the cocktail drugs administration.

Approximately 38 healthy subjects will be enrolled to achieve 28 evaluable healthy subjects complete the study.

Blood samples will be collected for PK analysis .

Conditions

  • Healthy Subjects

Interventions

DRUG

pimicotinib capsules

the effect of multiple oral doses of pimicotinib (50 mg QD) on the pharmacokinetics of fexofenadine (P-gp sensitive substrate), rosuvastatin (BCRP sensitive substrate) and metformin (MATE1 sensitive substrate). Fexofenadine and rosuvastatin will be administered together as a cocktail, and metformin will be given via staggered dosing from the cocktail drugs administration

Sponsors & Collaborators

  • Abbisko Therapeutics Co, Ltd

    lead INDUSTRY

Principal Investigators

  • Wei Zhao, Doctor · The First Affiliated Hospital Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-14
Primary Completion
2025-04-04
Completion
2025-05-22

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06779253 on ClinicalTrials.gov