ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of LY3009104(Baricitinib) for Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01247350
Recruitment Status : Completed
First Posted : November 24, 2010
Results First Posted : April 13, 2018
Last Update Posted : April 13, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: LY3009104 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Single- and Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3009104 in Japanese Healthy Subjects
Study Start Date : November 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Arm Intervention/treatment
Experimental: 2 mg LY3009104 (Cohort 1)
2mg administered once on day 1 (single dose)
Drug: LY3009104
Administered orally
Other Name: baricitinib
Experimental: 5 mg LY3009104 (Cohort 2)
5mg administered once on day 1 (single dose)
Drug: LY3009104
Administered orally
Other Name: 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 Name: 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 Name: 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



Primary Outcome Measures :
  1. Number of Participants With Clinically Significant Effects [ Time Frame: Days 1-10 for Cohorts 1 & 2, Days 1-7 for single dose of Cohorts 3 & 4, Days 8-31 for multiple doses ]
    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.


Secondary Outcome Measures :
  1. Pharmacokinetics: Maximum Concentration (Cmax) of LY3009104 [ Time Frame: 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 ]
    Cmax of Day 1 is Cmax after single dose, and Cmax of Day 17 is Cmax at steady-state.

  2. Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY3009104 [ Time Frame: 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 ]
    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.

  3. Pharmacokinetics: Half-Life(t1/2) of LY3009104 [ Time Frame: 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 ]
    Half life (t1/2) is the time measured for the plasma concentration of LY3009104 to decrease by one half.

  4. Pharmacokinetics: Apparent Volume of Distribution of LY3009104 [ Time Frame: 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 ]
    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.

  5. Pharmacokinetics: Apparent Total Body Clearance of LY3009104 [ Time Frame: 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 ]
    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.

  6. Pharmacokinetics: Time of Maximum Observed LY3009104 Concentration (Tmax) [ Time Frame: 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 ]
    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.

  7. Pharmacokinetics: Renal Excretion of LY3009104 [ Time Frame: Day 1: continuous for 24 hours ]
    Percentage of LY3009104 excreted in urine from zero to 24 hours.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01247350


Locations
United States, Hawaii
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.
Honolulu, Hawaii, United States
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01247350     History of Changes
Other Study ID Numbers: 14089
I4V-JE-JADM ( Other Identifier: Eli Lilly and Company )
First Posted: November 24, 2010    Key Record Dates
Results First Posted: April 13, 2018
Last Update Posted: April 13, 2018
Last Verified: September 2017