A Study of Baricitinib When Administered With Ketoconazole or Fluconazole in Healthy Participants

NCT01924299 | Completed Phase 1 Results

• 2 other identifiers: 14607I4V-MC-JAGJ
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to look at the effect of ketoconazole and fluconazole on how much baricitinib gets into the blood stream. The study will also look at the tolerability of baricitinib and ketoconazole when given together and the tolerability of baricitinib and fluconazole when given together. Participants will be recruited into 1 of 2 treatment groups (Group A or Group B). Each treatment group will participate in 2 study periods. Participants will take baricitinib alone in 1 period and baricitinib with either ketoconazole or fluconazole in the other period. This study will last approximately 7 weeks.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (6)

• Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity [AUC(0-∞)] of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Ketoconazole

  Days 1 and 6: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdose

• PK: AUC(0-∞) of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Fluconazole

  Days 1 and 7: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdose

• PK: Maximum Concentration (Cmax) of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Ketoconazole

  Days 1 and 6: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdose

• PK: Cmax of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Fluconazole

  Days 1 and 7: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdose

• PK: Time of Maximum Observed Drug Concentration (Tmax) of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Ketoconazole

  Days 1 and 6: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdose

• PK: Tmax of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Fluconazole

  Days 1 and 7: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdose

Study Arms (2)

Baricitinib + Ketoconazole

EXPERIMENTAL

Baricitinib - 10 milligrams (mg) administered orally once on Day 1 of Period 1 and on Day 6 of Period 2. Ketoconazole - 400 mg administered orally once daily (QD) for 6 days (Day 3 through Day 8) in Period 2.

Drug: Baricitinib; Drug: Ketoconazole

Baricitinib + Fluconazole

EXPERIMENTAL

Baricitinib - 10 mg administered orally once on Day 1 of Period 1 and on Day 7 of Period 2. Fluconazole - 400 mg administered orally once on Day 3 of Period 2, followed by 200 mg administered orally QD for 6 days (Day 4 through Day 9) in Period 2.

Drug: Baricitinib; Drug: Fluconazole

Interventions

Baricitinib DRUG

Administered orally

Also known as: LY3009104

Baricitinib + Fluconazole; Baricitinib + Ketoconazole

Ketoconazole DRUG

Administered orally

Baricitinib + Ketoconazole

Fluconazole DRUG

Administered orally

Baricitinib + Fluconazole

Eligibility Criteria

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

You may qualify if:

• Overtly healthy as determined by medical history and physical examination
• Female participants not of childbearing potential due to surgical sterilization (at least 3 months after surgical hysterectomy, bilateral oophorectomy with or without hysterectomy, or bilateral tubal occlusion/ligation) confirmed by medical history or menopause
• Have a body mass index of 18 to 29 kilograms per square meter (kg/m\^2), inclusive, at screening

You may not qualify if:

• Participants who have previously completed or withdrawn from this study or any other study investigating baricitinib, and have previously received the study drug
• Have known allergies to baricitinib, ketoconazole, fluconazole, related compounds, or any components of the baricitinib, ketoconazole, or fluconazole formulations, or history of significant atopy
• Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
• Have a current or recent history \[less than 30 days prior to screening and/or less than 45 days prior to day of admission to Clinical Research Unit (CRU)\] of a clinically significant bacterial, fungal, parasitic, viral (not including rhinopharyngitis), or mycobacterial infection
• Have alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, total bilirubin, or gamma glutamyl transferase (GGT) values above the upper limit of the reference range for the local laboratory at screening or day of admission to CRU
• Have an absolute neutrophil count (ANC) less than 2 times 10\^9 per liter (L) \[2000 cells per microliter (μL)\] at screening or day of admission to CRU. For abnormal values, a single repeat will be allowed
• Intend to use over-the-counter or prescription medication and/or herbal supplements within 14 days prior to dosing and during the study (with the exception of occasional paracetamol, which will be permitted at the discretion of the investigator), or intended use of vitamin supplements from Day 1 until discharge from the CRU
• Have used or intend to use any drugs or substances that are known to be substrates, inhibitors, or inducers of cytochrome P450 (CYP) 3A4, CYP2C9, or CYP2C19 within 30 days prior to dosing and throughout the study

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; Ketoconazole; Fluconazole

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Triazoles; Azoles

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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2013
• First Posted: August 16, 2013
• Study Start: August 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: June 6, 2017
• Results First Posted: April 21, 2017

Record last verified: 2017-05

Locations

GB (1)