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

NCT ID: NCT04608344

Last Updated: 2022-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-04
• Study Completion Date: 2021-01-13

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Sequence AB

Participants will receive atorvastatin (ATV) 40 mg tablet on Day 1, followed by a washout period of 1 day, and then pravastatin (PRA) 40 mg + rosuvastatin (ROS) 10 mg tablets on Day 3 in Treatment A, Period 1. In Treatment B, Period 2 participants will receive filgotinib 200 mg tablet once daily for 11 days, with ATV 40 mg on Day 12 and PRA 40 mg + ROS 10 mg tablets on Day 14. Period 1 and Period 2 will be separated by a washout period of 3 days.

Group Type: EXPERIMENTAL

Atorvastatin

Intervention Type: DRUG

Administered as single dose tablet orally.

Pravastatin

Intervention Type: DRUG

Administered as single dose tablet orally.

Rosuvastatin

Intervention Type: DRUG

Administered as single dose tablet orally.

Filgotinib

Intervention Type: DRUG

Administered as tablet orally once daily for 11 days.

Sequence BA

Participants will receive filgotinib 200 mg tablet once daily for 11 days, with ATV 40 mg on Day 6 and PRA 40 mg + ROS 10 mg tablets on Day 8 in Treatment B, Period 1. In Treatment A, Period 2 participants will receive ATV 40 mg tablet on Day 18, followed by a washout period of 1 day and PRA 40 mg + ROS 10 mg tablets on Day 20. Period 1 and Period 2 will be separated by a washout period of 6 days.

Group Type: EXPERIMENTAL

Atorvastatin

Intervention Type: DRUG

Administered as single dose tablet orally.

Pravastatin

Intervention Type: DRUG

Administered as single dose tablet orally.

Rosuvastatin

Intervention Type: DRUG

Administered as single dose tablet orally.

Filgotinib

Intervention Type: DRUG

Administered as tablet orally once daily for 11 days.

Interventions

Atorvastatin

Administered as single dose tablet orally.

Intervention Type: DRUG

Pravastatin

Administered as single dose tablet orally.

Intervention Type: DRUG

Rosuvastatin

Administered as single dose tablet orally.

Intervention Type: DRUG

Filgotinib

Administered as tablet orally once daily for 11 days.

Intervention Type: DRUG

Other Intervention Names

GS-6034; GLPG0634; Jyseleca

Eligibility Criteria

Inclusion Criteria

• Be a nonsmoker. The use of nicotine or nicotine-containing products must be discontinued 90 days prior to the first dose of study drug.
• Have a calculated body mass index (BMI) of greater than or equal to (≥) 19.0 and less than or equal to (≤) 30.0 kilogram per meter square (kg/m^2) at screening.
• Have a creatinine clearance (CLcr) ≥ 90 milliliters per minute (mL/min) (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at screening and upon admission.
• Female participants of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at clinic admission.
• Male participants must be surgically sterile.
• Male participants and female participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
• Screening laboratory evaluations and 12-lead electrocardiogram (ECG) evaluations must be without clinically significant abnormalities as assessed by the investigator.
• Have liver biometric tests such as alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, and total bilirubin below the upper limit of normal at screening.
• Must be willing and able to comply with all study requirements.
• Must, in the opinion of the investigator, be in good health based upon medical history and physical examination, including vital signs.
• Participants must not have donated blood within 56 days of study entry or plasma within 7 days of study entry and must refrain from blood donation from clinic admission, throughout the study period, and continuing for at least 30 days following the last dose of study drug.

Exclusion Criteria

• Positive serum pregnancy test (Female participants).
• Lactating female.
• Have received any investigational drug/device within 30 days prior to study dosing (or within 5 half-lives of the drug, whichever is longer).
• Have current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance or participant safety, or a positive drug or alcohol test at screening or admission.
• Have a positive test result for human immunodeficiency virus type 1 (HIV-1) antibody, hepatitis B virus (HBV) surface antigen (HBsAg), or hepatitis C virus (HCV) antibody at screening.
• Have positive Coronavirus Disease 2019 (COVID-19) Real-Time Reverse.
• Transcriptase-Polymerase Chain Reaction (RT-PCR) testing on screening and admission.
• Have poor venous access that limits phlebotomy.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Galapagos NV

INDUSTRY

Sponsor Role: collaborator

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilead Study Director

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

Prism Research, LLC

Saint Paul, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

GS-US-417-5937

Identifier Type: -

Identifier Source: org_study_id