Trial Outcomes & Findings for A Drug Drug Interaction (DDI) Study of Baricitinib (LY3009104) and Digoxin in Healthy Participants (NCT NCT01859078)
NCT ID: NCT01859078
Last Updated: 2017-06-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
28 participants
Primary outcome timeframe
Predose up to 24 hours post-dose on Days 7 and 16
Results posted on
2017-06-06
Participant Flow
Participant milestones
| Measure |
Baricitinib + Digoxin
Digoxin - 0.5 milligrams (mg) administered orally, twice daily (BID), 12 hours apart on Day 1. Then, 0.25 mg administered orally, once daily (QD) on Days 2 through 16.
Baricitinib - 10 mg administered orally, QD, immediately prior to digoxin on Days 8 through 16.
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Drug Drug Interaction (DDI) Study of Baricitinib (LY3009104) and Digoxin in Healthy Participants
Baseline characteristics by cohort
| Measure |
Baricitinib + Digoxin
n=28 Participants
Digoxin - 0.5 mg administered orally, BID, 12 hours apart on Day 1. Then, 0.25 mg administered orally, QD on Days 2 through 16.
Baricitinib - 10 mg administered orally, QD, immediately prior to digoxin on Days 8 through 16.
|
|---|---|
|
Age, Continuous
|
33.4 years
STANDARD_DEVIATION 11.3 • n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United Kingdom
|
28 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Predose up to 24 hours post-dose on Days 7 and 16Population: All enrolled participants who received study drug and had PK data to calculate AUCτ. Participants were analyzed based on the treatment they received.
Outcome measures
| Measure |
Digoxin Only
n=28 Participants
0.5 mg digoxin administered orally, BID, 12 hours apart on Day 1. Then, 0.25 mg administered orally, QD on Days 2 through 7.
|
Baricitinib + Digoxin
n=28 Participants
10 mg baricitinib administered orally, QD, immediately prior to 0.25 mg digoxin administered orally, QD on Days 8 through 16.
|
|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUCτ) of Digoxin
|
18.7 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 18
|
16.8 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 20
|
PRIMARY outcome
Timeframe: Predose up to 24 hours post-dose on Days 7 and 16Population: All enrolled participants who received study drug and had PK data to calculate Cmax. Participants were analyzed based on the treatment they received.
Outcome measures
| Measure |
Digoxin Only
n=28 Participants
0.5 mg digoxin administered orally, BID, 12 hours apart on Day 1. Then, 0.25 mg administered orally, QD on Days 2 through 7.
|
Baricitinib + Digoxin
n=28 Participants
10 mg baricitinib administered orally, QD, immediately prior to 0.25 mg digoxin administered orally, QD on Days 8 through 16.
|
|---|---|---|
|
PK: Maximum Concentration (Cmax) of Digoxin
|
2.04 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 23
|
1.80 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 20
|
PRIMARY outcome
Timeframe: Predose up to 24 hours post-dose on Days 7 and 16Population: All enrolled participants who received study drug and had PK data to calculate tmax. Participants were analyzed based on the treatment they received.
Outcome measures
| Measure |
Digoxin Only
n=28 Participants
0.5 mg digoxin administered orally, BID, 12 hours apart on Day 1. Then, 0.25 mg administered orally, QD on Days 2 through 7.
|
Baricitinib + Digoxin
n=28 Participants
10 mg baricitinib administered orally, QD, immediately prior to 0.25 mg digoxin administered orally, QD on Days 8 through 16.
|
|---|---|---|
|
PK: Time of Maximum Observed Drug Concentration (Tmax) of Digoxin
|
1.00 hours (h)
Interval 0.5 to 2.0
|
1.00 hours (h)
Interval 0.42 to 2.0
|
SECONDARY outcome
Timeframe: 0 to 24 hours post-dose on Days 7 and 16Population: All enrolled participants who received study drug and had PK data to calculate Aeτ. Participants were analyzed based on the treatment they received.
Outcome measures
| Measure |
Digoxin Only
n=28 Participants
0.5 mg digoxin administered orally, BID, 12 hours apart on Day 1. Then, 0.25 mg administered orally, QD on Days 2 through 7.
|
Baricitinib + Digoxin
n=28 Participants
10 mg baricitinib administered orally, QD, immediately prior to 0.25 mg digoxin administered orally, QD on Days 8 through 16.
|
|---|---|---|
|
PK: Amount of Drug Excreted Unchanged During 1 Dosing Interval (Aeτ) of Digoxin
|
0.177 milligrams (mg)
Geometric Coefficient of Variation 18
|
0.155 milligrams (mg)
Geometric Coefficient of Variation 22
|
SECONDARY outcome
Timeframe: Predose to 24 hours post-dose on Days 7 and 16Population: All enrolled participants who received study drug and had PK data to calculate CLr. Participants were analyzed based on the treatment they received.
CLr is the volume of plasma from which study drug is completely removed by the kidney in a given time and is calculated as Aeτ divided by AUCτ.
Outcome measures
| Measure |
Digoxin Only
n=28 Participants
0.5 mg digoxin administered orally, BID, 12 hours apart on Day 1. Then, 0.25 mg administered orally, QD on Days 2 through 7.
|
Baricitinib + Digoxin
n=28 Participants
10 mg baricitinib administered orally, QD, immediately prior to 0.25 mg digoxin administered orally, QD on Days 8 through 16.
|
|---|---|---|
|
PK: Renal Clearance (CLr) of Digoxin
|
9.46 Liters/hour (L/h)
Geometric Coefficient of Variation 20
|
9.20 Liters/hour (L/h)
Geometric Coefficient of Variation 18
|
Adverse Events
Digoxin Only
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Baricitinib + Digoxin
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Digoxin Only
n=28 participants at risk
0.5 mg digoxin administered orally, BID, 12 hours apart on Day 1. Then, 0.25 mg administered orally, QD on Days 2 through 7.
|
Baricitinib + Digoxin
n=28 participants at risk
10 mg baricitinib administered orally, QD, immediately prior to 0.25 mg digoxin administered orally, QD on Days 8 through 16.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
3.6%
1/28 • Number of events 1
|
10.7%
3/28 • Number of events 3
|
|
General disorders
Fatigue
|
7.1%
2/28 • Number of events 2
|
3.6%
1/28 • Number of events 1
|
|
Nervous system disorders
Headache
|
17.9%
5/28 • Number of events 5
|
7.1%
2/28 • Number of events 3
|
|
Renal and urinary disorders
Pollakiuria
|
10.7%
3/28 • Number of events 3
|
0.00%
0/28
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60