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Trial record 11 of 62 for:    Baricitinib

A Study of Baricitinib and Ciclosporin in Healthy Participants

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ClinicalTrials.gov Identifier: NCT01968057
Recruitment Status : Completed
First Posted : October 23, 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: Ciclosporin
Enrollment 18
Recruitment Details  
Pre-assignment Details This was an open-label, 2-period, fixed-sequence study.
Arm/Group Title Baricitinib + Ciclosporin
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4 milligrams (mg) baricitinib administered orally on Day 1 of Period 1.

4 mg baricitinib co-administered with 600 mg ciclosporin on Day 4 of Period 2.

Period Title: Period 1 (Day 1 to Predosing Day 4)
Started 18
Received Baricitinib 18
Completed 18
Not Completed 0
Period Title: Period 2 (At Dosing Day 4 to Day 7)
Started 18
Received Baricitinib + Ciclosporin 18
Completed 18
Not Completed 0
Arm/Group Title Baricitinib + Ciclosporin
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4 mg baricitinib administered orally on Day 1 of Period 1.

4 mg baricitinib co-administered with 600 mg ciclosporin on Day 4 of Period 2.

Overall Number of Baseline Participants 18
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All enrolled participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
38.4  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
3
  16.7%
Male
15
  83.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
18
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 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
0
   0.0%
White
18
 100.0%
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 18 participants
18
1.Primary Outcome
Title Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib
Hide Description [Not Specified]
Time Frame Days 1 and 4: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose
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Hide Analysis Population Description
All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + ciclosporin in Period 2) and had PK data to calculate Cmax of baricitinib.
Arm/Group Title Baricitinib Baricitinib + Ciclosporin
Hide Arm/Group Description:
4 mg baricitinib administered orally on Day 1 of Period 1.
4 mg baricitinib co-administered with 600 mg ciclosporin on Day 4 of Period 2.
Overall Number of Participants Analyzed 18 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms/milliliter (ng/mL)
36.2
(25%)
35.8
(22%)
2.Primary Outcome
Title PK: Area Under the Concentration Curve From Time Zero to Infinity [AUC (0-∞)] of Baricitinib
Hide Description [Not Specified]
Time Frame Days 1 and 4: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + ciclosporin in Period 2) and had PK data to calculate AUC (0-∞) of baricitinib.
Arm/Group Title Baricitinib Baricitinib + Ciclosporin
Hide Arm/Group Description:
4 mg baricitinib administered orally on Day 1 of Period 1.
4 mg baricitinib co-administered with 600 mg ciclosporin on Day 4 of Period 2.
Overall Number of Participants Analyzed 18 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms*hour/milliliter (ng*h/mL)
241
(24%)
311
(26%)
3.Primary Outcome
Title PK: Time of Maximum Observed Drug Concentration (Tmax) of Baricitinib
Hide Description [Not Specified]
Time Frame Days 1 and 4: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + ciclosporin in Period 2) and had PK data to calculate Tmax of baricitinib.
Arm/Group Title Baricitinib Baricitinib + Ciclosporin
Hide Arm/Group Description:
4 mg baricitinib administered orally on Day 1 of Period 1.
4 mg baricitinib co-administered with 600 mg ciclosporin on Day 4 of Period 2.
Overall Number of Participants Analyzed 18 18
Median (Full Range)
Unit of Measure: hours
1.00
(0.50 to 1.00)
2.00
(0.50 to 4.00)
Time Frame Baseline through study completion (up to Day 14).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Baricitinib Baricitinib + Ciclosporin
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4 mg baricitinib administered orally on Day 1 of Period 1.

Adverse events are reported from baseline through predose on Day 4.

4 mg baricitinib co-administered with 600 mg ciclosporin on Day 4 of Period 2.

Adverse events are reported from postdose on Day 4 up to Day 14.

All-Cause Mortality
Baricitinib Baricitinib + Ciclosporin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Baricitinib Baricitinib + Ciclosporin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/18 (0.00%)      0/18 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Baricitinib Baricitinib + Ciclosporin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/18 (50.00%)      15/18 (83.33%)    
Gastrointestinal disorders     
Abdominal pain upper  1  1/18 (5.56%)  1 0/18 (0.00%)  0
Constipation  1  2/18 (11.11%)  2 1/18 (5.56%)  1
Defaecation urgency  1  0/18 (0.00%)  0 2/18 (11.11%)  2
Lip dry  1  0/18 (0.00%)  0 1/18 (5.56%)  1
Nausea  1  0/18 (0.00%)  0 8/18 (44.44%)  8
General disorders     
Asthenia  1  0/18 (0.00%)  0 1/18 (5.56%)  1
Catheter site pain  1  1/18 (5.56%)  1 0/18 (0.00%)  0
Catheter site related reaction  1  0/18 (0.00%)  0 2/18 (11.11%)  2
Chest pain  1  0/18 (0.00%)  0 1/18 (5.56%)  1
Fatigue  1  0/18 (0.00%)  0 2/18 (11.11%)  2
Feeling hot  1  0/18 (0.00%)  0 6/18 (33.33%)  6
Lethargy  1  0/18 (0.00%)  0 1/18 (5.56%)  1
Thirst  1  0/18 (0.00%)  0 2/18 (11.11%)  2
Vessel puncture site anaesthesia  1  0/18 (0.00%)  0 1/18 (5.56%)  1
Vessel puncture site swelling  1  0/18 (0.00%)  0 1/18 (5.56%)  1
Musculoskeletal and connective tissue disorders     
Back pain  1  1/18 (5.56%)  1 1/18 (5.56%)  1
Pain in extremity  1  1/18 (5.56%)  1 0/18 (0.00%)  0
Nervous system disorders     
Dizziness  1  0/18 (0.00%)  0 5/18 (27.78%)  5
Dysgeusia  1  0/18 (0.00%)  0 1/18 (5.56%)  1
Head discomfort  1  0/18 (0.00%)  0 1/18 (5.56%)  1
Headache  1  3/18 (16.67%)  3 8/18 (44.44%)  9
Paraesthesia  1  0/18 (0.00%)  0 3/18 (16.67%)  3
Reproductive system and breast disorders     
Dysmenorrhoea  1  1/3 (33.33%)  1 1/3 (33.33%)  1
Respiratory, thoracic and mediastinal disorders     
Dry throat  1  1/18 (5.56%)  1 1/18 (5.56%)  1
Nasal congestion  1  0/18 (0.00%)  0 1/18 (5.56%)  1
Oropharyngeal pain  1  0/18 (0.00%)  0 2/18 (11.11%)  2
Rhinorrhoea  1  0/18 (0.00%)  0 1/18 (5.56%)  1
Throat irritation  1  0/18 (0.00%)  0 2/18 (11.11%)  2
Skin and subcutaneous tissue disorders     
Acne  1  1/18 (5.56%)  1 0/18 (0.00%)  0
Hyperhidrosis  1  0/18 (0.00%)  0 1/18 (5.56%)  1
Skin warm  1  0/18 (0.00%)  0 1/18 (5.56%)  1
Vascular disorders     
Hot flush  1  0/18 (0.00%)  0 2/18 (11.11%)  2
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: NCT01968057     History of Changes
Other Study ID Numbers: 14605
I4V-MC-JAGH ( Other Identifier: Eli Lilly and Company )
First Submitted: October 18, 2013
First Posted: October 23, 2013
Results First Submitted: March 10, 2017
Results First Posted: April 21, 2017
Last Update Posted: June 6, 2017