A Study of Baricitinib and Ciclosporin in Healthy Participants

NCT01968057 | Completed Phase 1 Results

• 2 other identifiers: 14605I4V-MC-JAGH
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Baricitinib

EXPERIMENTAL

Single oral dose of 4 milligrams (mg) baricitinib on Day 1

Drug: Baricitinib

Baricitinib + Ciclosporin

EXPERIMENTAL

Single oral dose of 4 mg baricitinib co-administered with a single oral dose of 600 mg ciclosporin on Day 4

Drug: Baricitinib; Drug: Ciclosporin

Interventions

Baricitinib DRUG

Administered orally

Also known as: LY3009104

Baricitinib; Baricitinib + Ciclosporin

Ciclosporin DRUG

Administered orally

Baricitinib + Ciclosporin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (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.

Leeds, West Yorkshire, LS2 9LH, United Kingdom

Location

MeSH Terms

Interventions

baricitinib; Cyclosporine

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2013
• First Posted: October 23, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 6, 2017
• Results First Posted: April 21, 2017

Record last verified: 2017-05

Locations

GB (1)