Phase 1 Completed N=18 Basic Science

A Study of Baricitinib and Probenecid in Healthy Participants

Healthy Volunteers

Source: ClinicalTrials.gov NCT01937026 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2017

Primary outcomePrimary: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib — 36.2; 37.3 nanograms/milliliter (ng/mL)

Summary

The purposes of this study are to assess how the body handles baricitinib when it is given with another drug called probenecid. The study doctor will measure the amount of baricitinib that is absorbed into the blood stream and the time that it takes to remove baricitinib from the body. The safety and tolerability of these drugs will be studied. The study will last about 18 days from the first dose to the end of the study (not including screening).

Outcome Measures

Outcome	Result	p-value
PRIMARY Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib	36.2; 37.3	—
PRIMARY PK: Area Under the Concentration Curve From Time 0 to Infinity [AUC (0-∞)] of Baricitinib	236; 480	—

Eligibility Criteria

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 square (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 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Are participants who have previously completed or withdrawn from this study or any other study investigating baricitinib, and have previously received baricitinib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, probenecid, related compounds, or any components of the baricitinib or probenecid 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 capable of significantly altering the absorption, metabolism, or elimination of drugs;
Have a history of or current gout or gouty arthritis
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, or mycobacterial infection
Have had symptomatic herpes zoster or herpes simplex infection within 90 days prior to the first dose
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
Are women who are lactating
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 first dose of study drug until discharge from the Clinical Research Unit (CRU)
Have consumed or intend to consume grapefruit or grapefruit-containing products within 7 days prior to the first dose and throughout the study
Have used or intend to use any drugs or substances that are known to be substrates, inhibitors, or inducers of organic anion transporter (OAT)3 or cytochrome P450 (CYP) 3A4
Have donated or lost blood of more than 500 milliliter (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 study
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01937026). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.