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| Name | Class |
|---|---|
| Lakefront Biotherapeutics NV | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug | Administered as single dose tablet orally. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prism Research, LLC | Saint Paul | Minnesota | 55114 | United States |
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/
18 months after study completion
A secured external environment with username, password, and RSA code.
55 participants were screened.
Participants were enrolled at a study site in the United States. The first participant was screened on 04 November 2020. The last study visit occurred on 13 January 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence AB | Participants received a single oral dose of atorvastatin (ATV) 40 mg tablet on Day 1, followed by a washout period of 1 day, and then a single oral dose of pravastatin (PRA) 40 mg + rosuvastatin (ROS) 10 mg tablets on Day 3 in Treatment A, Period 1. In Treatment B, Period 2 participants received an oral dose of filgotinib 200 mg tablet once daily for 11 days, with a single oral dose of ATV 40 mg on Day 12 and a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 14. Period 1 and Period 2 were separated by a washout period of 3 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 (AB: 3 Days, BA: 11 Days) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 25, 2020 | Nov 1, 2021 |
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| Pravastatin |
| Drug |
Administered as single dose tablet orally. |
|
| Rosuvastatin | Drug | Administered as single dose tablet orally. |
|
| Filgotinib | Drug | Administered as tablet orally once daily for 11 days. |
|
|
| 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. | Sequence AB: First dose up to 47 days, Sequence BA: First dose up to 50 days |
| FG001 | Sequence BA | Participants received an oral dose of filgotinib 200 mg tablet once daily for 11 days, with a single oral dose of ATV 40 mg on Day 6 and a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 8 in Treatment B, Period 1. In Treatment A, Period 2 participants received single oral dose of ATV 40 mg tablet on Day 18, followed by a washout period of 1 day and a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 20. Period 1 and Period 2 were separated by a washout period of 6 days. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Period 2 (AB: 11 Days, BA: 3 Days) |
|
The Safety Analysis Set included all randomized participants who received at least 1 dose of any study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence AB | Participants received a single oral dose of ATV 40 mg tablet on Day 1, followed by a washout period of 1 day, and then a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 3 in Treatment A, Period 1. In Treatment B, Period 2 participants received an oral dose of filgotinib 200 mg tablet once daily for 11 days, with a single oral dose of ATV 40 mg on Day 12 and a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 14. Period 1 and Period 2 were separated by a washout period of 3 days. |
| BG001 | Sequence BA | Participants received an oral dose of filgotinib 200 mg tablet once daily for 11 days, with a single oral dose of ATV 40 mg on Day 6 and a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 8 in Treatment B, Period 1. In Treatment A, Period 2 participants received single oral dose of ATV 40 mg tablet on Day 18, followed by a washout period of 1 day and a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 20. Period 1 and Period 2 were separated by a washout period of 6 days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | h*ng/mL | 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 |
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| |||||||||||||||||||||||||||||
| Primary | PK Parameter: AUCinf of ATV, PRA, and ROS | AUCinf is defined as the concentration of drug extrapolated to infinite time. | Participants in the PK Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | h*ng/mL | 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 |
| |||||||||||||||||||||||||||||||
| Primary | PK Parameter: Cmax of ATV, PRA, and ROS | Cmax is defined as the maximum observed concentration of drug. | Participants in the PK Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | ng/mL | 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 | 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. | All randomized participants who received at least 1 dose of that particular study drug. | Posted | Number | percentage of participants | Sequence AB: First dose up to 47 days, Sequence BA: First dose up to 50 days |
| ||||||||||||||||||||||||||||||||
| Secondary | 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. | Participants randomized and received at least 1 dose of that particular study drug with available data were analyzed. | Posted | Number | percentage of participants | Sequence AB: First dose up to 47 days, Sequence BA: First dose up to 50 days |
|
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
Adverse Event: All randomized participants who received at least 1 dose of that particular study drug.
All Cause-Mortality: All Randomized Analysis Set included all participants randomized into the study after screening.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atorvastatin | Participants either received a single oral dose of ATV 40 mg tablet on Day 1 in Treatment A, Period 1 or a single oral dose of ATV 40 mg on Day 12 in Treatment B, Period 2 or a single oral dose of ATV 40 mg on Day 6 in Treatment B, Period 1 or a single oral dose of ATV 40 mg tablet on Day 18 in Treatment A, Period 2. | 0 | 27 | 0 | 26 | 2 | 26 |
| EG001 | Pravastatin + Rosuvastatin | Participants either received a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 3 in Treatment A, Period 1 or a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 14 in Treatment B, Period 2 or a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 8 in Treatment B, Period 1 or a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 20 in Treatment A, Period 2. | 0 | 27 | 0 | 25 | 4 | 25 |
| EG002 | Filgotinib | Participants either received an oral dose of filgotinib 200 mg tablet once daily for 11 days in Treatment B, Period 2 or an oral dose of filgotinib 200 mg tablet once daily for 11 days in Treatment B, Period 1. | 0 | 27 | 0 | 26 | 13 | 26 |
| EG003 | Filgotinib + Atorvastatin | Participants either received an oral dose of filgotinib 200 mg tablet once daily for 11 days, with a single oral dose of ATV 40 mg on Day 12 in Treatment B, Period 2 or an oral dose of filgotinib 200 mg tablet once daily for 11 days, with a single oral dose of ATV 40 mg on Day 6 in Treatment B, Period 1. | 0 | 27 | 0 | 26 | 2 | 26 |
| EG004 | Filgotinib + Pravastatin + Rosuvastatin | Participants either received an oral dose of filgotinib 200 mg tablet once daily for 11 days with a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 14 in Treatment B, Period 2 or an oral dose of filgotinib 200 mg tablet once daily for 11 days with a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 8 in Treatment B, Period 1. | 0 | 27 | 0 | 26 | 0 | 26 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA Version 23.1 | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 23, 2021 | Nov 1, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| D017035 | Pravastatin |
| D000068718 | Rosuvastatin Calcium |
| C584571 | GLPG0634 |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
Not provided
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| PRA |
|
|
| ROS |
|
|
Participants either received an oral dose of filgotinib 200 mg tablet once daily for 11 days, with a single oral dose of ATV 40 mg on Day 12 in Treatment B, Period 2 or an oral dose of filgotinib 200 mg tablet once daily for 11 days, with a single oral dose of ATV 40 mg on Day 6 in Treatment B, Period 1. |
| OG003 | Filgotinib + Pravastatin + Rosuvastatin | Participants either received an oral dose of filgotinib 200 mg tablet once daily for 11 days with a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 14 in Treatment B, Period 2 or an oral dose of filgotinib 200 mg tablet once daily for 11 days with a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 8 in Treatment B, Period 1. |
|
|
Participants either received an oral dose of filgotinib 200 mg tablet once daily for 11 days, with a single oral dose of ATV 40 mg on Day 12 in Treatment B, Period 2 or an oral dose of filgotinib 200 mg tablet once daily for 11 days, with a single oral dose of ATV 40 mg on Day 6 in Treatment B, Period 1.
| OG003 | Filgotinib + Pravastatin + Rosuvastatin | Participants either received an oral dose of filgotinib 200 mg tablet once daily for 11 days with a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 14 in Treatment B, Period 2 or an oral dose of filgotinib 200 mg tablet once daily for 11 days with a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 8 in Treatment B, Period 1. |
|
|
| OG002 | Filgotinib | Participants either received an oral dose of filgotinib 200 mg tablet once daily for 11 days in Treatment B, Period 2 or an oral dose of filgotinib 200 mg tablet once daily for 11 days in Treatment B, Period 1. |
| OG003 | Filgotinib + Atorvastatin | Participants either received an oral dose of filgotinib 200 mg tablet once daily for 11 days, with a single oral dose of ATV 40 mg on Day 12 in Treatment B, Period 2 or an oral dose of filgotinib 200 mg tablet once daily for 11 days, with a single oral dose of ATV 40 mg on Day 6 in Treatment B, Period 1. |
| OG004 | Filgotinib + Pravastatin + Rosuvastatin | Participants either received an oral dose of filgotinib 200 mg tablet once daily for 11 days with a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 14 in Treatment B, Period 2 or an oral dose of filgotinib 200 mg tablet once daily for 11 days with a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 8 in Treatment B, Period 1. |
|
|
| OG002 | Filgotinib | Participants either received an oral dose of filgotinib 200 mg tablet once daily for 11 days in Treatment B, Period 2 or an oral dose of filgotinib 200 mg tablet once daily for 11 days in Treatment B, Period 1. |
| OG003 | Filgotinib + Atorvastatin | Participants either received an oral dose of filgotinib 200 mg tablet once daily for 11 days, with a single oral dose of ATV 40 mg on Day 12 in Treatment B, Period 2 or an oral dose of filgotinib 200 mg tablet once daily for 11 days, with a single oral dose of ATV 40 mg on Day 6 in Treatment B, Period 1. |
| OG004 | Filgotinib + Pravastatin + Rosuvastatin | Participants either received an oral dose of filgotinib 200 mg tablet once daily for 11 days with a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 14 in Treatment B, Period 2 or an oral dose of filgotinib 200 mg tablet once daily for 11 days with a single oral dose of PRA 40 mg + ROS 10 mg tablets on Day 8 in Treatment B, Period 1. |
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