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Trial record 39 of 62 for:    Baricitinib

A Study of Baricitinib and Simvastatin in Healthy Participants

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ClinicalTrials.gov Identifier: NCT01960140
Recruitment Status : Completed
First Posted : October 10, 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 Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Healthy Volunteers
Interventions Drug: Baricitinib
Drug: Simvastatin
Enrollment 40
Recruitment Details  
Pre-assignment Details This was an open-label, fixed-sequence, 2-period study of healthy participants.
Arm/Group Title Simvastatin Then Baricitinib and Simvastatin
Hide Arm/Group Description

Period 1: 40-milligram (mg) tablet of simvastatin administered orally on Day 1.

Period 2: 10-mg dose of baricitinib (2 × 4-mg and 1 × 2-mg tablets) administered orally once daily (QD) on Days 3 through 7, with coadministration of 40-mg simvastatin tablet on Day 6.

Period Title: Period 1 (Days 1-2)
Started 40
Received Simvastatin 40
Completed 40
Not Completed 0
Period Title: Period 2 (Days 3-18)
Started 40
Received At Least 1 Dose of Baricitinib 40
Received Simvastatin 38
Completed 38
Not Completed 2
Reason Not Completed
Adverse Event             2
Arm/Group Title Simvastatin Then Baricitinib and Simvastatin
Hide Arm/Group Description

Period 1: 40-mg tablet of simvastatin administered orally on Day 1.

Period 2: 10-mg dose of baricitinib (2 × 4-mg and 1 × 2-mg tablets) administered orally QD on Days 3 through 7, with coadministration of 40-mg simvastatin tablet on Day 6.

Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
All enrolled participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants
40.0  (13.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
5
  12.5%
Male
35
  87.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
40
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   2.5%
White
39
  97.5%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United Kingdom Number Analyzed 40 participants
40
1.Primary Outcome
Title Pharmacokinetics (PK): Maximum Concentration (Cmax) of Simvastatin and Simvastatin Acid
Hide Description The Cmax of simvastatin [a cytochrome P450 (CYP) 3A substrate] and its active acid metabolite (simvastatin acid) is reported.
Time Frame Period 1, Day 1 and Period 2, Day 6: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 48 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received study drug (simvastatin in Period 1 and at least 1 dose of baricitinib and simvastatin in Period 2) and had evaluable PK data.
Arm/Group Title Simvastatin Baricitinib and Simvastatin
Hide Arm/Group Description:
Period 1: 40-mg tablet of simvastatin administered orally on Day 1.
Period 2: 10-mg dose of baricitinib (2 × 4-mg and 1 × 2-mg tablets) administered orally QD on Days 3 through 7, with coadministration of 40-mg simvastatin tablet on Day 6.
Overall Number of Participants Analyzed 40 38
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms per milliliter (ng/mL)
Simvastatin
6.85
(74%)
4.65
(57%)
Simvastatin Acid
1.93
(68%)
1.60
(50%)
2.Primary Outcome
Title PK: Area Under the Concentration Versus Time Curve From Zero to Infinity [AUC(0-∞)] of Simvastatin and Simvastatin Acid
Hide Description The AUC(0-∞) of simvastatin (a CYP3A substrate) and its active acid metabolite (simvastatin acid) is reported.
Time Frame Period 1, Day 1 and Period 2, Day 6: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 48 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received study drug (simvastatin in Period 1 and at least 1 dose of baricitinib and simvastatin in Period 2) and had evaluable PK data.
Arm/Group Title Simvastatin Baricitinib and Simvastatin
Hide Arm/Group Description:
Period 1: 40-mg tablet of simvastatin administered orally on Day 1.
Period 2: 10-mg dose of Baricitinib (2 × 4-mg and 1 × 2-mg tablets) administered orally QD on Days 3 through 7, with coadministration of 40-mg simvastatin tablet on Day 6.
Overall Number of Participants Analyzed 39 36
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms*hour/milliliter (ng*h/mL)
Simvastatin (n=39, 36)
40.7
(86%)
33.7
(75%)
Simvastatin Acid (n=33, 32)
26.4
(81%)
21.0
(64%)
Time Frame Baseline through study completion (up to Day 18)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Simvastatin Baricitinib Baricitinib and Simvastatin
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A 40-mg tablet of simvastatin administered orally on Day 1.

Adverse events (AEs) are reported from baseline through predose on Day 3.

A 10-mg dose of baricitinib (2 × 4-mg and 1 × 2-mg tablets) administered orally QD on Days 3 through 5.

AEs are reported postdose on Day 3 through predose on Day 6.

A 10-mg dose of baricitinib (2 × 4-mg and 1 × 2-mg tablets) administered orally QD on Days 6 and 7, with coadministration of 40-mg simvastatin tablet on Day 6.

AEs are reported postdose on Day 6 up to Day 18.

All-Cause Mortality
Simvastatin Baricitinib Baricitinib and Simvastatin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Simvastatin Baricitinib Baricitinib and Simvastatin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/40 (0.00%)      0/40 (0.00%)      0/38 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Simvastatin Baricitinib Baricitinib and Simvastatin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/40 (7.50%)      1/40 (2.50%)      3/38 (7.89%)    
Infections and infestations       
Nasopharyngitis  1  0/40 (0.00%)  0 0/40 (0.00%)  0 2/38 (5.26%)  2
Nervous system disorders       
Headache  1  3/40 (7.50%)  4 1/40 (2.50%)  1 1/38 (2.63%)  1
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: NCT01960140     History of Changes
Other Study ID Numbers: 14606
I4V-MC-JAGI ( Other Identifier: Eli Lilly and Company )
First Submitted: October 8, 2013
First Posted: October 10, 2013
Results First Submitted: March 10, 2017
Results First Posted: April 21, 2017
Last Update Posted: June 6, 2017