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

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ClinicalTrials.gov Identifier: NCT04608344
Recruitment Status : Completed
First Posted : October 29, 2020
Last Update Posted : July 30, 2021
Sponsor:
Collaborator:
Galapagos NV
Information provided by (Responsible Party):
Gilead Sciences

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Atorvastatin Drug: Pravastatin Drug: Rosuvastatin Drug: Filgotinib Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 1 Study to Evaluate OATP Transporter-Mediated Drug-Drug Interactions Between Filgotinib and Statins as Probe Drugs in Healthy Participants
Actual Study Start Date : November 4, 2020
Actual Primary Completion Date : January 13, 2021
Actual Study Completion Date : January 13, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Experimental: Sequence AB
Atorvastatin (ATV) 40 mg (Day 1); Washout period (Day 2); Pravastatin (PRA) 40 mg + Rosuvastatin (ROS) 10 mg (Day 3); Washout period (Days 4-6) in Treatment A Period 1; Filgotinib (FIL) 200 mg (Days 7-11). FIL 200 mg + ATV 40 mg (Day 12 ); FIL 200 mg (Day 13); FIL + PRA 40 mg + ROS 10 mg (Day 14); FIL 200 mg (Days 15-17) in Treatment B Period 2.
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.
Other Names:
  • GS-6034
  • GLPG0634

Experimental: Sequence BA
FIL 200 mg (Days 1-5); FIL 200 mg + ATV 40 mg (Day 6); FIL 200 mg (Day 7); FIL + PRA 40 mg + ROS 10 mg (Day 8); FIL 200 mg (Days 9-11); Washout period (Days 12-17) in Treatment B Period 1. ATV 40 mg (Day 18); Washout period (Day 19); PRA 40 mg + ROS 10 mg (Day 20) in Treatment A Period 2.
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.
Other Names:
  • GS-6034
  • GLPG0634




Primary Outcome Measures :
  1. Area Under the Concentration Versus Time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of ATV, PRA, and ROS [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose (Sequence AB: Days 1 and 12 up to 48 hours; Days 3 and 14 up to 72 hours. Sequence BA: Days 6 and 18 up to 48 hours; Days 8 and 20 up to 72 hours) ]
  2. Area Under the Concentration Versus Time Curve Extrapolated to Infinite Time (AUCinf) of ATV, PRA, and ROS [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose (Sequence AB: Days 1 and 12 up to 48 hours; Days 3 and 14 up to 72 hours. Sequence BA: Days 6 and 18 up to 48 hours; Days 8 and 20 up to 72 hours) ]
  3. Maximum Observed Plasma Concentration (Cmax) for ATV, PRA, and ROS [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose (Sequence AB: Days 1 and 12 up to 48 hours; Days 3 and 14 up to 72 hours. Sequence BA: Days 6 and 18 up to 48 hours; Days 8 and 20 up to 72 hours) ]

Secondary Outcome Measures :
  1. Percentage of Participants Experiencing Treatment-Emergent Adverse Events [ Time Frame: Up to 26 days for sequence AB and up to 29 days for sequence BA ]
  2. Percentage of Participants Experiencing Laboratory Abnormalities [ Time Frame: Up to 26 days for sequence AB and up to 29 days for sequence BA ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04608344


Locations
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United States, Minnesota
Prism Research, LLC
Saint Paul, Minnesota, United States, 55114
Sponsors and Collaborators
Gilead Sciences
Galapagos NV
Investigators
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Study Director: Gilead Study Director Gilead Sciences
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT04608344    
Other Study ID Numbers: GS-US-417-5937
First Posted: October 29, 2020    Key Record Dates
Last Update Posted: July 30, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Atorvastatin
Rosuvastatin Calcium
Pravastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors