Rheumatoid ArthritisPhase 1NCT04608344

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 testing Atorvastatin, Pravastatin and Rosuvastatin in people with Rheumatoid Arthritis, run by Gilead Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Rheumatoid Arthritis
What is being tested?: Atorvastatin, Pravastatin and Rosuvastatin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 1 siteUnited States
Study dates: 4 Nov 2020to 13 Jan 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

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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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Prism Research, LLC
Saint Paul, Minnesota, 55114

Other trials in United States

About this study

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

Conditions: Rheumatoid Arthritis
Being tested: Atorvastatin, Pravastatin, Rosuvastatin, Filgotinib
Medical subject headings: Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AtorvastatinDrug
Administered as single dose tablet orally.
PravastatinDrug
Administered as single dose tablet orally.
RosuvastatinDrug
Administered as single dose tablet orally.
FilgotinibDrug
Also called GS-6034, GLPG0634, Jyseleca
Administered as tablet orally once daily for 11 days.

Study groups in NCT04608344
Study group	Role	What they receive
Sequence AB	Experimental	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. Receives: Drug: Atorvastatin; Drug: Pravastatin; Drug: Rosuvastatin; Drug: Filgotinib
Sequence BA	Experimental	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. Receives: Drug: Atorvastatin; Drug: Pravastatin; Drug: Rosuvastatin; Drug: Filgotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetic (PK) Parameter: AUClast of ATV, PRA, and ROS
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Measured: AB (Days 1,3,12,14) and BA (Days 6,8,18,20): Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 postdose; AB (Days 1,12) and BA (Days 6,18): 5,10,36 hours post dose; AB (Days 3,14) and BA (Days 8,20): 72 hours postdose
PK Parameter: AUCinf of ATV, PRA, and ROS
AUCinf is defined as the concentration of drug extrapolated to infinite time.
Measured: AB (Days 1,3,12,14) and BA (Days 6,8,18,20): Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 postdose; AB (Days 1,12) and BA (Days 6,18): 5,10,36 hours post dose; AB (Days 3,14) and BA (Days 8,20): 72 hours postdose
PK Parameter: Cmax of ATV, PRA, and ROS
Cmax is defined as the maximum observed concentration of drug.
Measured: AB (Days 1,3,12,14) and BA (Days 6,8,18,20): Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 postdose; AB (Days 1,12) and BA (Days 6,18): 5,10,36 hours post dose; AB (Days 3,14) and BA (Days 8,20): 72 hours postdose

Secondary outcomes (2)

Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant administered a study drug, which did not necessarily have a causal relationship with the treatment. AE was therefore any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug. TEAEs: AE with an onset date on or after the study drug start date and no later than 30 days after study drug stop date; or any AE leading to study drug discontinuation.
Measured: Sequence AB: First dose up to 47 days, Sequence BA: First dose up to 50 days
Percentage of Participants With Severity Grade 3 or Above Treatment-Emergent Laboratory Abnormalities
Treatment-emergent laboratory abnormalities were graded using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 of Adverse Events and Laboratory abnormalities. Laboratory abnormalities were graded as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (Life-threatening), Grade 5 (Death). Percentage of participants with Grade 3 or higher treatment-emergent laboratory abnormalities were reported.
Measured: Sequence AB: First dose up to 47 days, Sequence BA: First dose up to 50 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Nov 202013 Jan 2021

First posted29 Oct 2020
Study start4 Nov 2020
Primary completion13 Jan 2021
Study completion13 Jan 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
More trials run by Gilead SciencesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04608344
Sponsor's protocol ID: GS-US-417-5937
Status last verified: May 2022
First submitted: 23 Oct 2020
Last updated: 14 Jun 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Study to Evaluate OATP Transporter-Mediated Drug-Drug Interactions Between Filgotinib and Statins as Probe Drugs in Healthy Participants
ClinicalTrials.gov ID: NCT04608344
Acronym / sponsor ID: GS-US-417-5937
Conditions: Rheumatoid Arthritis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Collaborators: Lakefront Biotherapeutics NV
Study start: 4 Nov 2020 (actual)
Primary completion: 13 Jan 2021 (actual)
Study completion: 13 Jan 2021 (actual)
First posted: 29 Oct 2020 (actual)
Results: Posted 19 Jan 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Sequence AB	Experimental	Drug: Atorvastatin, Drug: Pravastatin, Drug: Rosuvastatin, Drug: FilgotinibParticipants 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.
Sequence BA	Experimental	Drug: Atorvastatin, Drug: Pravastatin, Drug: Rosuvastatin, Drug: FilgotinibParticipants 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.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (11 listed)

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.

Key exclusion criteria (9 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AtorvastatinAdministered as single dose tablet orally.	Drug	Sequence AB, Sequence BA
PravastatinAdministered as single dose tablet orally.	Drug	Sequence AB, Sequence BA
RosuvastatinAdministered as single dose tablet orally.	Drug	Sequence AB, Sequence BA
FilgotinibAlso: GS-6034, GLPG0634, JyselecaAdministered as tablet orally once daily for 11 days.	Drug	Sequence AB, Sequence BA

Primary outcome

Pharmacokinetic (PK) Parameter: AUClast of ATV, PRA, and ROS
Time frame: AB (Days 1,3,12,14) and BA (Days 6,8,18,20): Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 postdose; AB (Days 1,12) and BA (Days 6,18): 5,10,36 hours post dose; AB (Days 3,14) and BA (Days 8,20): 72 hours postdose
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
PK Parameter: AUCinf of ATV, PRA, and ROS
Time frame: AB (Days 1,3,12,14) and BA (Days 6,8,18,20): Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 postdose; AB (Days 1,12) and BA (Days 6,18): 5,10,36 hours post dose; AB (Days 3,14) and BA (Days 8,20): 72 hours postdose
AUCinf is defined as the concentration of drug extrapolated to infinite time.
PK Parameter: Cmax of ATV, PRA, and ROS
Time frame: AB (Days 1,3,12,14) and BA (Days 6,8,18,20): Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 postdose; AB (Days 1,12) and BA (Days 6,18): 5,10,36 hours post dose; AB (Days 3,14) and BA (Days 8,20): 72 hours postdose
Cmax is defined as the maximum observed concentration of drug.

2 secondary outcomes

Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)
Time frame: Sequence AB: First dose up to 47 days, Sequence BA: First dose up to 50 days
Percentage of Participants With Severity Grade 3 or Above Treatment-Emergent Laboratory Abnormalities
Time frame: Sequence AB: First dose up to 47 days, Sequence BA: First dose up to 50 days

Results and safety

Results posted to the registry on 19 Jan 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence AB	14	13
Sequence BA	13	12

Primary outcome: Pharmacokinetic (PK) Parameter: AUClast of ATV, PRA, and ROS

Time frame: AB (Days 1,3,12,14) and BA (Days 6,8,18,20): Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 postdose; AB (Days 1,12) and BA (Days 6,18): 5,10,36 hours post dose; AB (Days 3,14) and BA (Days 8,20): 72 hours postdose. Mean (Standard Deviation). Unit: h*ng/mL

Measure	Atorvastatin n = 25	Pravastatin + Rosuvastatin n = 25	Filgotinib + Atorvastatin n = 26	Filgotinib + Pravastatin + Rosuvastatin n = 26
ATV	78.8 (39.10)	–	70.2 (27.08)	–
PRA	–	199.5 (115.64)	–	232.5 (137.76)
ROS	–	62.6 (29.03)	–	89.3 (34.63)

Population analysed: Participants in the PK Analysis Set (all randomized participants who received at least 1 dose of study drug and had at least 1 non-missing PK concentration datum reported by PK laboratory for each respective analyte) with available data were analyzed.

Primary outcome: PK Parameter: AUCinf of ATV, PRA, and ROS

Measure	Atorvastatin n = 25	Pravastatin + Rosuvastatin n = 25	Filgotinib + Atorvastatin n = 26	Filgotinib + Pravastatin + Rosuvastatin n = 26
ATV	80.8 (39.76)	–	71.8 (27.30)	–
PRA	–	201.3 (116.38)	–	234.8 (137.43)
ROS	–	66.0 (29.53)	–	92.3 (34.94)

Population analysed: Participants in the PK Analysis Set with available data were analyzed.

Primary outcome: PK Parameter: Cmax of ATV, PRA, and ROS

Measure	Atorvastatin n = 25	Pravastatin + Rosuvastatin n = 25	Filgotinib + Atorvastatin n = 26	Filgotinib + Pravastatin + Rosuvastatin n = 26
ATV	19.7 (13.50)	–	15.0 (7.81)	–
PRA	–	84.2 (56.60)	–	99.2 (65.68)
ROS	–	7.5 (4.17)	–	12.3 (6.00)

Population analysed: Participants in the PK Analysis Set with available data were analyzed.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events: Sequence AB: First dose up to 47 days, Sequence BA: First dose up to 50 days All Cause-Mortality: Sequence AB: From randomization up to 47 days, Sequence BA: From randomization up to 50 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Atorvastatin	0 of 26 (0%)	2 of 26 (7.7%)	0 of 27
Pravastatin + Rosuvastatin	0 of 25 (0%)	4 of 25 (16%)	0 of 27
Filgotinib	0 of 26 (0%)	13 of 26 (50%)	0 of 27
Filgotinib + Atorvastatin	0 of 26 (0%)	2 of 26 (7.7%)	0 of 27
Filgotinib + Pravastatin + Rosuvastatin	0 of 26 (0%)	0 of 26 (0%)	0 of 27

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gilead Study Director study director

Gilead Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Atorvastatin, Pravastatin and Rosuvastatin in people with Rheumatoid Arthritis, run by Gilead Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetic (PK) Parameter: AUClast of ATV, PRA, and ROS (time frame: AB (Days 1,3,12,14) and BA (Days 6,8,18,20): Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 postdose; AB (Days 1,12) and BA (Days 6,18): 5,10,36 hours post dose; AB (Days 3,14) and BA (Days 8,20): 72 hours postdose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04608344.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2022.