A Study of Baricitinib and Omeprazole in Healthy Participants

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Baricitinib; Drug: Omeprazole

• Registration Number: NCT01925144
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The main purpose of this study is to find out how the body will react to a study drug called baricitinib when taken with another drug called omeprazole.

For each participant, this study will include 2 periods in fixed order. The study will last approximately 25 days, not including screening.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-15
• Study First Submitted QC: 2013-08-15
• Study First Posted: 2013-08-19
• Study Start: 2013-10
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Results First Submitted: 2017-03-10
• Results First Submitted QC: 2017-03-10
• Results First Posted: 2017-04-21
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-15
• Last Update Posted: 2017-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Overtly healthy as determined by medical history and physical examination
• Women 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

• Have known allergies to baricitinib, omeprazole, related compounds, or any components of the baricitinib or omeprazole formulations, or history of significant atopy
• Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological (including clotting disorders), 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 an absolute neutrophil count (ANC) less than 2 × 10^9 cells per liter (L) [2000 cells/microliter (μL)] at screening or Day -1. For abnormal values, a single repeat will be allowed
• Intend to use over-the-counter or prescription medication (including drugs and substances known to alter gastric potential hydrogen (pH), such as proton pump inhibitors or over-the-counter antacid remedies and/or herbal supplements within 14 days prior to dosing and during the study (with the exception of hormone replacement therapy (HRT) and 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 3A4 (CYP3A4) within 30 days prior to dosing and throughout the study
• Are unable to tolerate or unwilling to undergo insertion of a nasogastric pH probe for assessment of gastric pH during the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Baricitinib	Baricitinib	Baricitinib - 10 milligram (mg) tablet administered orally, once, on Day 1.
Baricitinib + Omeprazole	Baricitinib	Baricitinib - 10 mg tablet administered orally, once, on Day 10. Omeprazole - 40 mg capsule administered orally once daily (QD) for 8 days (Days 3 through 10).
Baricitinib + Omeprazole	Omeprazole	Baricitinib - 10 mg tablet administered orally, once, on Day 10. Omeprazole - 40 mg capsule administered orally once daily (QD) for 8 days (Days 3 through 10).

Primary Outcome Measures

Name	Time	Method
PK: Time of Maximum Observed Drug Concentration (Tmax) of Baricitinib	Days 1 and 10: predose of baricitinib, 0.5, 0.75, 1, 2, 3, 4, 6, 12, 24, 36 and 48 hours postdose
PK: Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity [AUC(0-∞)] of Baricitinib	Days 1 and 10: predose of baricitinib, 0.5, 0.75, 1, 2, 3, 4, 6, 12, 24, 36 and 48 hours postdose
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib	Days 1 and 10: predose of baricitinib, 0.5, 0.75, 1, 2, 3, 4, 6, 12, 24, 36 and 48 hours postdose

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.; 🇬🇧 Leeds, West Yorkshire, United Kingdom