A Study of Baricitinib and Simvastatin in Healthy Participants

Healthy Volunteers Clinical Trial

Official title:

Effects of Multiple Baricitinib (LY3009104) Doses on the Pharmacokinetics of a Cytochrome P450 3A Substrate, Simvastatin, in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01960140
• Other study ID #: 14606
• Secondary ID: I4V-MC-JAGI
• Status: Completed
• Phase: Phase 1
• First received: October 8, 2013
• Last updated: January 8, 2014
• Start date: October 2013
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• 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 purposes of this study are to determine the effects of baricitinib on the time it takes to remove simvastatin from the body and to look at how well-tolerated and safe baricitinib is when given alone and in combination with simvastatin. Side effects will be documented. The study will last approximately 7 days from the first dose to the end of the study (not including screening or follow-up).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 kilogram 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 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

• Have previously completed or withdrawn from this study or any other study investigating baricitinib, and have previously received baricitinib

• Have known allergies to baricitinib, simvastatin, related compounds, or any components of the baricitinib or simvastatin 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 (including hypothyroidism), hematological, or neurological disorders

• Have current or recent history of myalgia or muscle weakness

• 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 × 109/liter (L) (2000 cells/microliter [µL]) at screening or day prior to first dose of study drug. For abnormal values, a single repeat will be allowed

• 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

• Have been exposed to a live vaccine within 12 weeks prior to the first dose or expected to need/receive a live vaccine (including herpes zoster vaccination) during the course of the study

• 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 Day 1 until discharge from the Clinical Research Unit (CRU)

• Have consumed or intend to consume grapefruit or grapefruit-containing products within 14 days prior to the first dose and throughout the study

• 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 Clinical Research Unit (CRU) at the end of Period 2

• 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

Study Design

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Baricitinib
Administered orally
• Simvastatin
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: Maximum Concentration (Cmax) of Simvastatin and Simvastatin Acid		Predose through 48 hours postdose, Days 1 and 6	No
Primary	Pharmacokinetics: Area under the Concentration Curve from Zero to Infinity (AUC [0-8]) of Simvastatin and Simvastatin Acid		Predose through 48 hours postdose, Days 1 and 6	No