A Study of LY3009104(Baricitinib) for Healthy Subjects

A Single- and Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3009104 in Japanese Healthy Subjects

To evaluate the safety and tolerability of LY3009104 when given orally as single and multiple doses in Japanese healthy subjects.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: Placebo; Drug: LY3009104

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Hawaii
    • Honolulu, Hawaii, United States
      • 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.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy males or females. Male subjects: Agree to use 2 forms of highly effective methods of birth control with female partners of childbearing potential for the specified duration. Female subjects: Females must not be pregnant, breastfeeding, or at risk to become pregnant during study participation. Female subjects of childbearing potential must test negative for pregnancy at screening and agree to use 2 forms of highly effective methods of birth control, or remain abstinent for the specified duration.
• Up to third generation Japanese, that is defined as all of the subject's biological grandparents are of exclusive Japanese decent and have been born in Japan.
• Are between the body mass index (BMI) of 18.0 and 30.0 kg/m², inclusive at screening.

Exclusion Criteria:

• Are subjects who have previously completed or withdrawn from this study or any other study investigating LY3009104, and received the study drug.
• 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.
• Show evidence of significant active neuropsychiatric disease.
• Have current or recent history of herpes zoster or simplex in the last 90 days prior to randomization, or history of herpes zoster, such as disseminated herpes zoster involving multiple dermatomes, ocular involvement, including herpes zoster involving the ophthalmic branch of the trigeminal nerve.
• Have or have a history of rheumatoid arthritis.
• History of malignancy, with the exception of cured basal cell or squamous cell carcinoma of the skin.
• History of stomach or intestinal surgery, except that appendectomy and/or cholecystectomy will be allowed.
• Receipt of blood products within 2 months prior to study entry.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2 mg LY3009104 (Cohort 1); 2mg administered once on day 1 (single dose)	Drug: LY3009104; Administered orally; Other Names: baricitinib
Experimental: 5 mg LY3009104 (Cohort 2); 5mg administered once on day 1 (single dose)	Drug: LY3009104; Administered orally; Other Names: baricitinib
Experimental: 10 mg LY3009104 (Cohort 3); 10 mg administered on day 1 (single dose) and following a 7 day washout period, administered once daily for 10 days (multiple dose)	Drug: LY3009104; Administered orally; Other Names: baricitinib
Experimental: 14 mg LY3009104 (Cohort 4 ); 14 mg administered on day 1 (single dose) and following a 7 day washout period, administered once daily for 10 days (multiple dose)	Drug: LY3009104; Administered orally; Other Names: baricitinib
Placebo Comparator: Placebo; administered on day 1 (single dose) and following a 7 day washout period, administered once daily for 10 days (multiple dose)	Drug: Placebo; Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Clinically Significant Effects	Adverse events were considered clinically significant effects. A summary of serious adverse events and other nonserious adverse events are located in the Reported Adverse Event section.	Days 1-10 for Cohorts 1 & 2, Days 1-7 for single dose of Cohorts 3 & 4, Days 8-31 for multiple doses

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics: Maximum Concentration (Cmax) of LY3009104	Cmax of Day 1 is Cmax after single dose, and Cmax of Day 17 is Cmax at steady-state.	Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose
Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY3009104	AUC is the measure of total plasma exposure of a drug over a given time period. AUC of Day 1 is AUC from 0 to 24 hours. AUC of Day 17 is AUC during one dosing interval at steady-state.	Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose
Pharmacokinetics: Half-Life(t1/2) of LY3009104	Half life (t1/2) is the time measured for the plasma concentration of LY3009104 to decrease by one half.	Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose
Pharmacokinetics: Apparent Volume of Distribution of LY3009104	Apparent volume of distribution is used to quantify the distribution of a drug between plasma and the rest of the body after dosing. It is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Day 1, it is apparent volume of distribution during the terminal phase after single dose. Day 17, it is apparent volume of distribution during the terminal phase at steady-state.	Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose
Pharmacokinetics: Apparent Total Body Clearance of LY3009104	Apparent total body clearance is the volume of plasma from which the drug is completely removed in a given time period. For Day 1, it is apparent total body clearance of drug after single dose. For Day 17, it is apparent total body clearance of drug at steady-state.	Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 38 and 48 hours postdose
Pharmacokinetics: Time of Maximum Observed LY3009104 Concentration (Tmax)	Tmax is time to reach maximum observed drug concentration. For Day 1, it is tmax after single dose. For Day 17, it is tmax at steady-state.	Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 38 and 48 hours postdose
Pharmacokinetics: Renal Excretion of LY3009104	Percentage of LY3009104 excreted in urine from zero to 24 hours.	Day 1: continuous for 24 hours

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: November 17, 2010
• First Submitted That Met QC Criteria: November 22, 2010
• First Posted (Estimate): November 24, 2010

Study Record Updates

• Last Update Posted (Actual): April 13, 2018
• Last Update Submitted That Met QC Criteria: September 6, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 14089; I4V-JE-JADM (Other Identifier: Eli Lilly and Company)