NCT04608344

Study to Evaluate Organic Anion Transporting Polypeptide (OATP) Transporter-Mediated Drug-Drug Interactions Between Filgotinib and Statins as Probe Drugs in Healthy Participants

A Phase 1 Study to Evaluate OATP Transporter-Mediated Drug-Drug Interactions Between Filgotinib and Statins as Probe Drugs in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to evaluate the effect of filgotinib on a mixed organic anion transporting polypeptide/cytochrome P450 3A (OATP/CYP3A), OATP/ breast cancer resistance protein (BCRP), and OATP substrates using phenotypic probes.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Atorvastatin	Administered as single dose tablet orally.
DRUG	Pravastatin	Administered as single dose tablet orally.
DRUG	Rosuvastatin	Administered as single dose tablet orally.
DRUG	Filgotinib	Administered as tablet orally once daily for 11 days.

Timeline

• Start date: 2020-11-04
• Primary completion: 2021-01-13
• Completion: 2021-01-13
• First posted: 2020-10-29
• Last updated: 2022-06-14
• Results posted: 2022-01-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study