Study to Evaluate Organic Anion Transporting Polypeptide (OATP) Transporter-Mediated Drug-Drug Interactions Between Filgotinib and Statins as Probe Drugs in Healthy Participants
Sponsor
Gilead Sciences (Industry)
Overall Status
Completed
CT.gov ID
NCT04608344
Collaborator
Galapagos NV (Industry)
27
1
2
2.3
11.7
Study Details
Study Description
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 |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
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
:
Nov 4, 2020
Actual Primary Completion Date
:
Jan 13, 2021
Actual Study Completion Date
:
Jan 13, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sequence AB 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. |
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:
|
| Experimental: Sequence BA 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. |
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:
|
Outcome Measures
Primary Outcome Measures
- Pharmacokinetic (PK) Parameter: AUClast of ATV, PRA, and ROS [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 [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 [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.
Secondary Outcome Measures
- Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) [Sequence AB: First dose up to 47 days, Sequence BA: First dose up to 50 days]
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.
- Percentage of Participants With Severity Grade 3 or Above Treatment-Emergent Laboratory Abnormalities [Sequence AB: First dose up to 47 days, Sequence BA: First dose up to 50 days]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Key Inclusion Criteria:
-
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.
-
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.
Key Exclusion Criteria:
-
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.
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Prism Research, LLC | Saint Paul | Minnesota | United States | 55114 |
Sponsors and Collaborators
- Gilead Sciences
- Galapagos NV
Investigators
- Study Director: Gilead Study Director, Gilead Sciences
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT04608344
Other Study ID Numbers:
- GS-US-417-5937
First Posted:
Oct 29, 2020
Last Update Posted:
Jun 14, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | 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. |
|---|---|
| Pre-assignment Detail | 55 participants were screened. |
| Arm/Group Title | Sequence AB | Sequence BA |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Period Title: Period 1 (AB: 3 Days, BA: 11 Days) | ||
| STARTED | 14 | 13 |
| COMPLETED | 13 | 12 |
| NOT COMPLETED | 1 | 1 |
| Period Title: Period 1 (AB: 3 Days, BA: 11 Days) | ||
| STARTED | 13 | 12 |
| COMPLETED | 13 | 12 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Sequence AB | Sequence BA | Total |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | Total of all reporting groups |
| Overall Participants | 14 | 13 | 27 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
31
(7.2)
|
29
(7.6)
|
30
(7.3)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
14
100%
|
12
92.3%
|
26
96.3%
|
| Male |
0
0%
|
1
7.7%
|
1
3.7%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
0
0%
|
1
7.7%
|
1
3.7%
|
| Not Hispanic or Latino |
14
100%
|
12
92.3%
|
26
96.3%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
1
7.7%
|
1
3.7%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
3
21.4%
|
2
15.4%
|
5
18.5%
|
| White |
10
71.4%
|
9
69.2%
|
19
70.4%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
1
7.1%
|
1
7.7%
|
2
7.4%
|
Outcome Measures
| Title | Pharmacokinetic (PK) Parameter: AUClast of ATV, PRA, and ROS |
|---|---|
| Description | AUClast is defined as the concentration of drug from time zero to the last observable concentration. |
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Atorvastatin | Pravastatin + Rosuvastatin | Filgotinib + Atorvastatin | Filgotinib + Pravastatin + Rosuvastatin |
|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. |
| Measure Participants | 25 | 25 | 26 | 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)
|
| Title | PK Parameter: AUCinf of ATV, PRA, and ROS |
|---|---|
| Description | AUCinf is defined as the concentration of drug extrapolated to infinite time. |
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the PK Analysis Set with available data were analyzed. |
| Arm/Group Title | Atorvastatin | Pravastatin + Rosuvastatin | Filgotinib + Atorvastatin | Filgotinib + Pravastatin + Rosuvastatin |
|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. |
| Measure Participants | 25 | 25 | 26 | 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)
|
| Title | PK Parameter: Cmax of ATV, PRA, and ROS |
|---|---|
| Description | Cmax is defined as the maximum observed concentration of drug. |
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the PK Analysis Set with available data were analyzed. |
| Arm/Group Title | Atorvastatin | Pravastatin + Rosuvastatin | Filgotinib + Atorvastatin | Filgotinib + Pravastatin + Rosuvastatin |
|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. |
| Measure Participants | 25 | 25 | 26 | 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)
|
| Title | Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) |
|---|---|
| Description | 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. |
| Time Frame | Sequence AB: First dose up to 47 days, Sequence BA: First dose up to 50 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received at least 1 dose of that particular study drug. |
| Arm/Group Title | Atorvastatin | Pravastatin + Rosuvastatin | Filgotinib | Filgotinib + Atorvastatin | Filgotinib + Pravastatin + Rosuvastatin |
|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. |
| Measure Participants | 26 | 25 | 26 | 26 | 26 |
| Number [percentage of participants] |
19.2
137.1%
|
24.0
184.6%
|
65.4
242.2%
|
7.7
NaN
|
11.5
NaN
|
| Title | Percentage of Participants With Severity Grade 3 or Above Treatment-Emergent Laboratory Abnormalities |
|---|---|
| Description | 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. |
| Time Frame | Sequence AB: First dose up to 47 days, Sequence BA: First dose up to 50 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants randomized and received at least 1 dose of that particular study drug with available data were analyzed. |
| Arm/Group Title | Atorvastatin | Pravastatin + Rosuvastatin | Filgotinib | Filgotinib + Atorvastatin | Filgotinib + Pravastatin + Rosuvastatin |
|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. |
| Measure Participants | 26 | 25 | 26 | 24 | 26 |
| Number [percentage of participants] |
0
0%
|
0
0%
|
3.8
14.1%
|
0
NaN
|
0
NaN
|
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 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | 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. | |||||||||
| Arm/Group Title | Atorvastatin | Pravastatin + Rosuvastatin | Filgotinib | Filgotinib + Atorvastatin | Filgotinib + Pravastatin + Rosuvastatin | |||||
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. | |||||
All Cause Mortality |
||||||||||
| Atorvastatin | Pravastatin + Rosuvastatin | Filgotinib | Filgotinib + Atorvastatin | Filgotinib + Pravastatin + Rosuvastatin | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/27 (0%) | 0/27 (0%) | 0/27 (0%) | 0/27 (0%) | 0/27 (0%) | |||||
Serious Adverse Events |
||||||||||
| Atorvastatin | Pravastatin + Rosuvastatin | Filgotinib | Filgotinib + Atorvastatin | Filgotinib + Pravastatin + Rosuvastatin | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/26 (0%) | 0/25 (0%) | 0/26 (0%) | 0/26 (0%) | 0/26 (0%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
| Atorvastatin | Pravastatin + Rosuvastatin | Filgotinib | Filgotinib + Atorvastatin | Filgotinib + Pravastatin + Rosuvastatin | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/26 (7.7%) | 4/25 (16%) | 13/26 (50%) | 2/26 (7.7%) | 0/26 (0%) | |||||
| Gastrointestinal disorders | ||||||||||
| Nausea | 0/26 (0%) | 1/25 (4%) | 3/26 (11.5%) | 1/26 (3.8%) | 0/26 (0%) | |||||
| Constipation | 0/26 (0%) | 0/25 (0%) | 2/26 (7.7%) | 1/26 (3.8%) | 0/26 (0%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Musculoskeletal chest pain | 0/26 (0%) | 2/25 (8%) | 1/26 (3.8%) | 0/26 (0%) | 0/26 (0%) | |||||
| Nervous system disorders | ||||||||||
| Headache | 2/26 (7.7%) | 2/25 (8%) | 8/26 (30.8%) | 0/26 (0%) | 0/26 (0%) | |||||
| Reproductive system and breast disorders | ||||||||||
| Metrorrhagia | 0/26 (0%) | 0/25 (0%) | 2/26 (7.7%) | 0/26 (0%) | 0/26 (0%) | |||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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: The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or The study has been completed at all study sites for at least 2 years
Results Point of Contact
| Name/Title | Gilead Clinical Study Information Center |
|---|---|
| Organization | Gilead Sciences |
| Phone | 1-833-445-3230 (GILEAD-0) |
| GileadClinicalTrials@gilead.com |
Responsible Party:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT04608344
Other Study ID Numbers:
- GS-US-417-5937
First Posted:
Oct 29, 2020
Last Update Posted:
Jun 14, 2022
Last Verified:
May 1, 2022