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

Healthy Volunteers Clinical Trial

Official title:

The Effect of Ketoconazole or Fluconazole on the Pharmacokinetics of Baricitinib in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01924299
• Other study ID #: 14607
• Secondary ID: I4V-MC-JAGJ
• Status: Completed
• Phase: Phase 1
• First received: August 14, 2013
• Last updated: November 21, 2013
• Start date: August 2013
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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 one of 2 treatment groups (Group A, Group B). Each treatment group will participate in 2 study periods. Participants will take baricitinib alone in one period and baricitinib with either ketaconazole or fluconazole in the other period. This study will last approximately 7 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Participants who have previously completed or withdrawn from this study or any other study investigating baricitinib, and have previously received the study drug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) 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 clinical research unit

• 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 clinical research unit. 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 Clinical Research Unit (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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Baricitinib
Administered orally
• Ketoconazole
Administered orally
• Fluconazole
Administered orally

Locations

Country	Name	City	State
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Maximum concentration (Cmax) of Baricitinib		Predose of baricitinib on Day 1 up to 48 hours postdose in Period 1 and Predose of baricitinib on Day 6 or 7 up to 72 hours postdose in Period 2	No
Primary	Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (tmax) of Baricitinib		Predose of baricitinib on Day 1 up to 48 hours postdose in Period 1 and Predose of baricitinib on Day 6 or 7 up to 72 hours postdose in Period 2	No
Primary	Pharmacokinetics, Area Under the Plasma Concentration-Time Curve From Time 0 Hour (h) to Infinity (AUC0-8) of Baricitinib		Predose of baricitinib on Day 1 up to 48 hours postdose in Period 1 and Predose of baricitinib on Day 6 or 7 up to 72 hours postdose in Period 2	No