A Study of Baricitinib and Ciclosporin in Healthy Participants

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Baricitinib
Drug: Ciclosporin

Registration Number: NCT01968057

Lead Sponsor: Eli Lilly and Company

Brief Summary: 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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 18

Inclusion Criteria

Male participants: agree to use 2 reliable methods of birth control with female partners of childbearing potential during the study and for at least 3 months following the last dose of study drug
Female participants: women not of childbearing potential due to surgical sterilization confirmed by medical history, or menopause
Have a body mass index of 18.0 to 29.0 kilograms per meter squared (kg/m^2), inclusive
Have clinical laboratory test results within the normal reference range
Have normal renal function
Have normal blood pressure and pulse rate

Exclusion Criteria

Are currently enrolled in a clinical trial involving a study drug or off-label use of a drug or device, or are concurrently enrolled in any other type of medical research
Have completed or discontinued within the last 90 days from a clinical trial involving a study drug
Are participants who have previously completed or withdrawn from this study or any other study investigating baricitinib, and have previously received baricitinib
Have known allergies to baricitinib, ciclosporin, related compounds, or any components of the baricitinib or ciclosporin formulations, or history of significant atopy
Have an abnormality in the 12-lead electrocardiogram (ECG)
Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders
Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
Have a current or recent history of a clinically significant bacterial, fungal, parasitic, viral (not including rhinopharyngitis), or mycobacterial infection
Have had symptomatic herpes zoster or herpes simplex infection within 90 days prior to the first dose
Have an absolute neutrophil count (ANC) less than 2 × 10^9 cells/liter(L) [2000 cells/microliter (μL)] at screening or day prior to first dose of study drug
Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
Show evidence of hepatitis C infection and/or positive hepatitis C antibody
Show evidence of hepatitis B infection and/or positive hepatitis B surface antigen
Have a history of active tuberculosis within the last 5 years
Are women who are lactating or pregnant
Have been exposed to a live vaccine within 12 weeks prior to the first dose or expected to need/receive a live vaccine (including herpes zoster vaccination) during the course of the study
Intend to use over-the-counter or prescription medication (including salicylate drugs) and/or herbal supplements within 14 days prior to dosing and during the study or intended use of vitamin supplements from Day 1 until discharge from the Clinical Research Unit (CRU)
Have consumed or intend to consume grapefruit, Seville oranges, or products containing these fruits within 7 days prior to the first dose and until discharge from the CRU
Have donated or lost blood of more than 500 milliliters (mL) within the last 3 months
Have an average weekly alcohol intake that exceeds 28 units per week (males) and 21 units per week (females), or are unwilling to stop alcohol consumption from 48 hours prior to the first dose until discharge from the CRU at the end of Period 2
History of, in the opinion of the investigator, excessive methylxanthine use within the previous 6 months, such as greater than (>) 6 cups of coffee (or equivalent) per day
Currently smoke more than 10 cigarettes per day

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Baricitinib	Baricitinib	Single oral dose of 4 milligrams (mg) baricitinib on Day 1
Baricitinib + Ciclosporin	Ciclosporin	Single oral dose of 4 mg baricitinib co-administered with a single oral dose of 600 mg ciclosporin on Day 4
Baricitinib + Ciclosporin	Baricitinib	Single oral dose of 4 mg baricitinib co-administered with a single oral dose of 600 mg ciclosporin on Day 4

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): 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.
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Leeds, West Yorkshire, United Kingdom