Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I4V-MC-JAGH | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the effects of ciclosporin on the amount of baricitinib that is absorbed into the blood stream and the time it takes to remove baricitinib from the body. The study will also look at how well-tolerated and safe baricitinib is, when given alone and in combination with ciclosporin. Side effects will be documented. The study will last approximately 6 days from the first dose to the end of the study (not including screening or follow-up).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baricitinib | Experimental | Single oral dose of 4 milligrams (mg) baricitinib on Day 1 |
|
| Baricitinib + Ciclosporin | Experimental | Single oral dose of 4 mg baricitinib co-administered with a single oral dose of 600 mg ciclosporin on Day 4 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baricitinib | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib | Days 1 and 4: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose | |
| PK: Area Under the Concentration Curve From Time Zero to Infinity [AUC (0-∞)] of Baricitinib | Days 1 and 4: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose | |
| PK: Time of Maximum Observed Drug Concentration (Tmax) of Baricitinib | Days 1 and 4: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Leeds | West Yorkshire | LS2 9LH |
This was an open-label, 2-period, fixed-sequence study.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Baricitinib + Ciclosporin | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (Day 1 to Predosing Day 4) |
| ||||||||||||||||
| Period 2 (At Dosing Day 4 to Day 7) |
|
All enrolled participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Baricitinib + Ciclosporin | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms/milliliter (ng/mL) | Days 1 and 4: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose |
|
Baseline through study completion (up to Day 14).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Baricitinib | 4 mg baricitinib administered orally on Day 1 of Period 1. Adverse events are reported from baseline through predose on Day 4. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| C000596027 | baricitinib |
| D016572 | Cyclosporine |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Ciclosporin | Drug | Administered orally |
|
| United Kingdom |
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
|
|
| Primary | PK: Area Under the Concentration Curve From Time Zero to Infinity [AUC (0-∞)] of Baricitinib | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour/milliliter (ng*h/mL) | Days 1 and 4: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose |
|
|
|
| Primary | PK: Time of Maximum Observed Drug Concentration (Tmax) of Baricitinib | 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. | Posted | Median | Full Range | hours | Days 1 and 4: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose |
|
|
|
| 0 |
| 18 |
| 9 |
| 18 |
| EG001 | Baricitinib + Ciclosporin | 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. | 0 | 18 | 15 | 18 |
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Defaecation urgency | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Lip dry | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Catheter site related reaction | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Lethargy | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Thirst | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vessel puncture site anaesthesia | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vessel puncture site swelling | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Head discomfort | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Skin warm | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
Not provided
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |