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

• Status: Completed
• Trial end date: 2021-01-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gilead Sciences
• Collaborator: Galapagos NV
• Treatments: Atorvastatin; Pravastatin; Rosuvastatin Calcium

Criteria

Key Inclusion Criteria:

• Have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures.

• 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 milliliter 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 individuals of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at clinic admission.

• Male individuals must be surgically sterile.

• Male individuals and female individuals 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.

• Individuals 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.

Key Exclusion Criteria:

• Positive serum pregnancy test (Female individuals).

• 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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.