Disposition of 14C-LY3009104 Following Oral Administration in Healthy Human Subjects

NCT01299285 | Completed Phase 1 Results

• 2 other identifiers: 14010I4V-MC-JADG
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single dose study of radiolabeled \[14C\]-LY3009104 in healthy male volunteers to study the absorption, distribution, metabolism, and elimination of LY3009104. This study requires minimum of 7 days and maximum of 22 days stay. This study is for research purposes only and is not intended to treat any medical condition.

Conditions

Healthy Volunteers

Keywords

Absorption; Distribution; Metabolism; Excretion; Mass balance; Metabolic profile; Radiolabeled study; 14C

Outcome Measures

Primary Outcomes (1)

• Percentage of the Total Radioactive Dose Administered Excreted From Urine and Feces

  Baseline up to 120 hours

Secondary Outcomes (8)

• Plasma Pharmacokinetics: LY3009104 Area Under the Concentration-Time Curve From Time Zero to Infinity [AUC(0-∞)]

  Baseline up to 48 hours

• Plasma Pharmacokinetics: Radioactivity Area Under the Concentration-Time Curve From Time Zero to Infinity [AUC(0-∞)]

  Baseline up to 48 hours

• Plasma Pharmacokinetics: Maximum Observed LY3009104 Concentration (Cmax)

  Baseline up to 48 hours

• Plasma Pharmacokinetics: Maximum Observed Radioactivity Concentration (Cmax)

  Baseline up to 48 hours

• Plasma Pharmacokinetics: LY3009104 and Radioactivity Time to Maximum Observed Concentration (Tmax)

  Baseline up to 48 hours

Study Arms (1)

LY3009104

EXPERIMENTAL

Single 10-milligram (mg) oral dose containing 100 microcuries of 14C-labeled LY3009104

Drug: LY3009104

Interventions

LY3009104 DRUG

Administered orally

Also known as: Baricitinib

LY3009104

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Overtly healthy males, as determined by medical history and physical examination
• Will either be sterile or, if sexually active, agree to use a reliable method of birth control from check-in until 3 months after the end of the study
• Body mass index (BMI) between 19 and 30 kilogram/square meter (kg/m²)
• Experience on average 1 to 2 bowel movements per day
• Clinical laboratory test results within the normal reference range for the clinical research unit (CRU) or, results with acceptable deviations which are judged to be not clinically significant by the investigator
• Normal blood pressure and heart rate (sitting) as determined by the investigator
• Venous access sufficient to allow blood sampling
• Are reliable and willing to make themselves available for the duration of the study, and are willing to abide by the CRU policies and procedures, and study restrictions
• Have given written informed consent approved by Lilly and the Institutional Review Board (IRB) governing the CRU

You may not qualify if:

• Are currently enrolled in, have completed or discontinued, a clinical trial involving an investigational product or are concurrently enrolled in any other type of medical research judged not to be scientifically, or medically compatible with this study
• Have known allergies to LY3009104, related compounds, or any components of the formulation
• Have previously received the investigational product in this study, have completed or withdrawn from this study or any other study investigating LY3009104
• History or presence of an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, is clinically significant
• Current or recent history (\<30 days prior to Screening and/or \<45 days prior to Check-in) of a clinically significant bacterial, fungal, parasitic, viral (not including rhinopharyngitis), or mycobacterial infection
• An Absolute Neutrophil Count (ANC) less than 2000 cells/microliter. For abnormal values a single repeat will be allowed
• Have a history or presence of 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
• Show evidence of significant active neuropsychiatric disease and in particular evidence of significant medical or psychiatric illness within the past 12 months
• Have known substance dependence or abuse within 6 months prior to the study (according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition \[DSM-IV\] diagnosis), or regularly use known drugs of abuse and/or show positive findings on urinary drug screening
• Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
• Show evidence of hepatitis C and/or positive hepatitis C antibody
• Evidence hepatitis B (active or surface antigen positive \[HBsAg+\]) or hepatitis B core antibody positive, hepatitis B surface antibody negative (HBcAb+, HBsAb-)
• Use of prescription medication; over-the-counter medication; or herbal preparations containing St. John's Wort, kava, garlic, ginger, gingko biloba, or guarana within 14 days prior to admission
• Consumption of grapefruit or grapefruit-containing foods or juices within 7 days prior to dosing or at any time during the study
• Have an average weekly alcohol intake that exceeds 15 units per week, or are unwilling to stop alcohol consumption for the duration of the study (1 unit = 12 oz or 360 milliliter (mL) of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits)

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, 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Madison, Wisconsin, United States

Location

MeSH Terms

Interventions

baricitinib

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, 9AM - 5PM 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: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2011
• First Posted: February 18, 2011
• Study Start: February 1, 2011
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: June 8, 2017
• Results First Posted: April 21, 2017

Record last verified: 2017-05

Locations

US (1)