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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 23, 2020
First Posted Date  ICMJE October 29, 2020
Last Update Posted Date July 30, 2021
Actual Study Start Date  ICMJE November 4, 2020
Actual Primary Completion Date January 13, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2020)
  • 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) ]
  • 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) ]
  • 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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2020)
  • 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 ]
  • Percentage of Participants Experiencing Laboratory Abnormalities [ Time Frame: Up to 26 days for sequence AB and up to 29 days for sequence BA ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Organic Anion Transporting Polypeptide (OATP) Transporter-Mediated Drug-Drug Interactions Between Filgotinib and Statins as Probe Drugs in Healthy Participants
Official Title  ICMJE A Phase 1 Study to Evaluate OATP Transporter-Mediated Drug-Drug Interactions Between Filgotinib and Statins as Probe Drugs in Healthy Participants
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Atorvastatin
    • Drug: Pravastatin
    • Drug: Rosuvastatin
    • Drug: Filgotinib
  • 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.
    Interventions:
    • Drug: Atorvastatin
    • Drug: Pravastatin
    • Drug: Rosuvastatin
    • Drug: Filgotinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 19, 2021)
27
Original Estimated Enrollment  ICMJE
 (submitted: October 23, 2020)
30
Actual Study Completion Date  ICMJE January 13, 2021
Actual Primary Completion Date January 13, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04608344
Other Study ID Numbers  ICMJE GS-US-417-5937
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Galapagos NV
Investigators  ICMJE
Study Director: Gilead Study Director Gilead Sciences
PRS Account Gilead Sciences
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP