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Trial record 30 of 62 for:    Baricitinib

A Drug Drug Interaction (DDI) Study of Baricitinib (LY3009104) and Digoxin in Healthy Participants

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ClinicalTrials.gov Identifier: NCT01859078
Recruitment Status : Completed
First Posted : May 21, 2013
Results First Posted : April 21, 2017
Last Update Posted : June 6, 2017
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Healthy Volunteers
Interventions Drug: Baricitinib
Drug: Digoxin
Enrollment 28
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Baricitinib + Digoxin
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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.

Period Title: Overall Study
Started 28
Completed 28
Not Completed 0
Arm/Group Title Baricitinib + Digoxin
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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.

Overall Number of Baseline Participants 28
Hide Baseline Analysis Population Description
All enrolled participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants
33.4  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Female
0
   0.0%
Male
28
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
28
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   3.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
24
  85.7%
More than one race
3
  10.7%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United Kingdom Number Analyzed 28 participants
28
1.Primary Outcome
Title Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUCτ) of Digoxin
Hide Description [Not Specified]
Time Frame Predose up to 24 hours post-dose on Days 7 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received study drug and had PK data to calculate AUCτ. Participants were analyzed based on the treatment they received.
Arm/Group Title Digoxin Only Baricitinib + Digoxin
Hide Arm/Group Description:
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.
10 mg baricitinib administered orally, QD, immediately prior to 0.25 mg digoxin administered orally, QD on Days 8 through 16.
Overall Number of Participants Analyzed 28 28
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms*hour/milliliter (ng*h/mL)
18.7
(18%)
16.8
(20%)
2.Primary Outcome
Title PK: Maximum Concentration (Cmax) of Digoxin
Hide Description [Not Specified]
Time Frame Predose up to 24 hours post-dose on Days 7 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received study drug and had PK data to calculate Cmax. Participants were analyzed based on the treatment they received.
Arm/Group Title Digoxin Only Baricitinib + Digoxin
Hide Arm/Group Description:
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.
10 mg baricitinib administered orally, QD, immediately prior to 0.25 mg digoxin administered orally, QD on Days 8 through 16.
Overall Number of Participants Analyzed 28 28
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms/milliliter (ng/mL)
2.04
(23%)
1.80
(20%)
3.Primary Outcome
Title PK: Time of Maximum Observed Drug Concentration (Tmax) of Digoxin
Hide Description [Not Specified]
Time Frame Predose up to 24 hours post-dose on Days 7 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received study drug and had PK data to calculate tmax. Participants were analyzed based on the treatment they received.
Arm/Group Title Digoxin Only Baricitinib + Digoxin
Hide Arm/Group Description:
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.
10 mg baricitinib administered orally, QD, immediately prior to 0.25 mg digoxin administered orally, QD on Days 8 through 16.
Overall Number of Participants Analyzed 28 28
Median (Full Range)
Unit of Measure: hours (h)
1.00
(0.50 to 2.00)
1.00
(0.42 to 2.00)
4.Secondary Outcome
Title PK: Amount of Drug Excreted Unchanged During 1 Dosing Interval (Aeτ) of Digoxin
Hide Description [Not Specified]
Time Frame 0 to 24 hours post-dose on Days 7 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received study drug and had PK data to calculate Aeτ. Participants were analyzed based on the treatment they received.
Arm/Group Title Digoxin Only Baricitinib + Digoxin
Hide Arm/Group Description:
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.
10 mg baricitinib administered orally, QD, immediately prior to 0.25 mg digoxin administered orally, QD on Days 8 through 16.
Overall Number of Participants Analyzed 28 28
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: milligrams (mg)
0.177
(18%)
0.155
(22%)
5.Secondary Outcome
Title PK: Renal Clearance (CLr) of Digoxin
Hide Description 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.
Time Frame Predose to 24 hours post-dose on Days 7 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received study drug and had PK data to calculate CLr. Participants were analyzed based on the treatment they received.
Arm/Group Title Digoxin Only Baricitinib + Digoxin
Hide Arm/Group Description:
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.
10 mg baricitinib administered orally, QD, immediately prior to 0.25 mg digoxin administered orally, QD on Days 8 through 16.
Overall Number of Participants Analyzed 28 28
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liters/hour (L/h)
9.46
(20%)
9.20
(18%)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Digoxin Only Baricitinib + Digoxin
Hide Arm/Group Description 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. 10 mg baricitinib administered orally, QD, immediately prior to 0.25 mg digoxin administered orally, QD on Days 8 through 16.
All-Cause Mortality
Digoxin Only Baricitinib + Digoxin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Digoxin Only Baricitinib + Digoxin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/28 (0.00%)      0/28 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Digoxin Only Baricitinib + Digoxin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/28 (35.71%)      6/28 (21.43%)    
Gastrointestinal disorders     
Diarrhoea  1  1/28 (3.57%)  1 3/28 (10.71%)  3
General disorders     
Fatigue  1  2/28 (7.14%)  2 1/28 (3.57%)  1
Nervous system disorders     
Headache  1  5/28 (17.86%)  5 2/28 (7.14%)  3
Renal and urinary disorders     
Pollakiuria  1  3/28 (10.71%)  3 0/28 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01859078     History of Changes
Other Study ID Numbers: 14609
I4V-MC-JAGL ( Other Identifier: Eli Lilly and Company )
First Submitted: May 17, 2013
First Posted: May 21, 2013
Results First Submitted: March 10, 2017
Results First Posted: April 21, 2017
Last Update Posted: June 6, 2017