Trial Outcomes & Findings for Study to Evaluate Organic Anion Transporting Polypeptide (OATP) Transporter-Mediated Drug-Drug Interactions Between Filgotinib and Statins as Probe Drugs in Healthy Participants (NCT NCT04608344)
NCT ID: NCT04608344
Last Updated: 2022-06-14
Results Overview
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
27 participants
Primary outcome timeframe
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
Results posted on
2022-06-14
Participant Flow
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.
55 participants were screened.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Period 1 (AB: 3 Days, BA: 11 Days)
STARTED
|
14
|
13
|
|
Period 1 (AB: 3 Days, BA: 11 Days)
COMPLETED
|
13
|
12
|
|
Period 1 (AB: 3 Days, BA: 11 Days)
NOT COMPLETED
|
1
|
1
|
|
Period 2 (AB: 11 Days, BA: 3 Days)
STARTED
|
13
|
12
|
|
Period 2 (AB: 11 Days, BA: 3 Days)
COMPLETED
|
13
|
12
|
|
Period 2 (AB: 11 Days, BA: 3 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Period 1 (AB: 3 Days, BA: 11 Days)
Adverse Event
|
0
|
1
|
|
Period 1 (AB: 3 Days, BA: 11 Days)
Investigator's Discretion
|
1
|
0
|
Baseline Characteristics
Study to Evaluate Organic Anion Transporting Polypeptide (OATP) Transporter-Mediated Drug-Drug Interactions Between Filgotinib and Statins as Probe Drugs in Healthy Participants
Baseline characteristics by cohort
| Measure |
Sequence AB
n=14 Participants
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.
|
Sequence BA
n=13 Participants
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
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
31 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
29 years
STANDARD_DEVIATION 7.6 • n=7 Participants
|
30 years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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 postdosePopulation: 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.
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Outcome measures
| Measure |
Atorvastatin
n=25 Participants
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.
|
Pravastatin + Rosuvastatin
n=25 Participants
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.
|
Filgotinib + Atorvastatin
n=26 Participants
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.
|
Filgotinib + Pravastatin + Rosuvastatin
n=26 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameter: AUClast of ATV, PRA, and ROS
ATV
|
78.8 h*ng/mL
Standard Deviation 39.10
|
—
|
70.2 h*ng/mL
Standard Deviation 27.08
|
—
|
—
|
|
Pharmacokinetic (PK) Parameter: AUClast of ATV, PRA, and ROS
PRA
|
—
|
199.5 h*ng/mL
Standard Deviation 115.64
|
—
|
232.5 h*ng/mL
Standard Deviation 137.76
|
—
|
|
Pharmacokinetic (PK) Parameter: AUClast of ATV, PRA, and ROS
ROS
|
—
|
62.6 h*ng/mL
Standard Deviation 29.03
|
—
|
89.3 h*ng/mL
Standard Deviation 34.63
|
—
|
PRIMARY outcome
Timeframe: 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 postdosePopulation: Participants in the PK Analysis Set with available data were analyzed.
AUCinf is defined as the concentration of drug extrapolated to infinite time.
Outcome measures
| Measure |
Atorvastatin
n=25 Participants
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.
|
Pravastatin + Rosuvastatin
n=25 Participants
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.
|
Filgotinib + Atorvastatin
n=26 Participants
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.
|
Filgotinib + Pravastatin + Rosuvastatin
n=26 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
PK Parameter: AUCinf of ATV, PRA, and ROS
PRA
|
—
|
201.3 h*ng/mL
Standard Deviation 116.38
|
—
|
234.8 h*ng/mL
Standard Deviation 137.43
|
—
|
|
PK Parameter: AUCinf of ATV, PRA, and ROS
ROS
|
—
|
66.0 h*ng/mL
Standard Deviation 29.53
|
—
|
92.3 h*ng/mL
Standard Deviation 34.94
|
—
|
|
PK Parameter: AUCinf of ATV, PRA, and ROS
ATV
|
80.8 h*ng/mL
Standard Deviation 39.76
|
—
|
71.8 h*ng/mL
Standard Deviation 27.30
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 postdosePopulation: Participants in the PK Analysis Set with available data were analyzed.
Cmax is defined as the maximum observed concentration of drug.
Outcome measures
| Measure |
Atorvastatin
n=25 Participants
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.
|
Pravastatin + Rosuvastatin
n=25 Participants
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.
|
Filgotinib + Atorvastatin
n=26 Participants
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.
|
Filgotinib + Pravastatin + Rosuvastatin
n=26 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
PK Parameter: Cmax of ATV, PRA, and ROS
ATV
|
19.7 ng/mL
Standard Deviation 13.50
|
—
|
15.0 ng/mL
Standard Deviation 7.81
|
—
|
—
|
|
PK Parameter: Cmax of ATV, PRA, and ROS
PRA
|
—
|
84.2 ng/mL
Standard Deviation 56.60
|
—
|
99.2 ng/mL
Standard Deviation 65.68
|
—
|
|
PK Parameter: Cmax of ATV, PRA, and ROS
ROS
|
—
|
7.5 ng/mL
Standard Deviation 4.17
|
—
|
12.3 ng/mL
Standard Deviation 6.00
|
—
|
SECONDARY outcome
Timeframe: Sequence AB: First dose up to 47 days, Sequence BA: First dose up to 50 daysPopulation: All randomized participants who received at least 1 dose of that particular study drug.
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.
Outcome measures
| Measure |
Atorvastatin
n=26 Participants
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.
|
Pravastatin + Rosuvastatin
n=25 Participants
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.
|
Filgotinib + Atorvastatin
n=26 Participants
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.
|
Filgotinib + Pravastatin + Rosuvastatin
n=26 Participants
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.
|
Filgotinib + Pravastatin + Rosuvastatin
n=26 Participants
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.
|
|---|---|---|---|---|---|
|
Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)
|
19.2 percentage of participants
|
24.0 percentage of participants
|
65.4 percentage of participants
|
7.7 percentage of participants
|
11.5 percentage of participants
|
SECONDARY outcome
Timeframe: Sequence AB: First dose up to 47 days, Sequence BA: First dose up to 50 daysPopulation: Participants randomized and received at least 1 dose of that particular study drug with available data were analyzed.
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.
Outcome measures
| Measure |
Atorvastatin
n=26 Participants
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.
|
Pravastatin + Rosuvastatin
n=25 Participants
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.
|
Filgotinib + Atorvastatin
n=26 Participants
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.
|
Filgotinib + Pravastatin + Rosuvastatin
n=24 Participants
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.
|
Filgotinib + Pravastatin + Rosuvastatin
n=26 Participants
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.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Severity Grade 3 or Above Treatment-Emergent Laboratory Abnormalities
|
0 percentage of participants
|
0 percentage of participants
|
3.8 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
Atorvastatin
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Pravastatin + Rosuvastatin
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Filgotinib
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Filgotinib + Atorvastatin
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Filgotinib + Pravastatin + Rosuvastatin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Atorvastatin
n=26 participants at risk
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.
|
Pravastatin + Rosuvastatin
n=25 participants at risk
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.
|
Filgotinib
n=26 participants at risk
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.
|
Filgotinib + Atorvastatin
n=26 participants at risk
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.
|
Filgotinib + Pravastatin + Rosuvastatin
n=26 participants at risk
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.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/26 • 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.
|
4.0%
1/25 • 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.
|
11.5%
3/26 • 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.
|
3.8%
1/26 • 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.
|
0.00%
0/26 • 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.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/26 • 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.
|
0.00%
0/25 • 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.
|
7.7%
2/26 • 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.
|
3.8%
1/26 • 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.
|
0.00%
0/26 • 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.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/26 • 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.
|
8.0%
2/25 • 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.
|
3.8%
1/26 • 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.
|
0.00%
0/26 • 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.
|
0.00%
0/26 • 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.
|
|
Nervous system disorders
Headache
|
7.7%
2/26 • 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.
|
8.0%
2/25 • 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.
|
30.8%
8/26 • 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.
|
0.00%
0/26 • 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.
|
0.00%
0/26 • 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.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/26 • 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.
|
0.00%
0/25 • 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.
|
7.7%
2/26 • 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.
|
0.00%
0/26 • 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.
|
0.00%
0/26 • 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.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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
- Publication restrictions are in place
Restriction type: OTHER