Clinical trial NCT01247350: A Study of LY3009104(Baricitinib) for Healthy Subjects
Official title: A Single- and Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3009104 in Japanese Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2010-11-24
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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* Are subjects who have previously completed or withdrawn from this study or any other study investigating LY3009104, and received the study drug.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.

Primary outcomes:
measure: Number of Participants With Clinically Significant Effects
timeFrame: Days 1-10 for Cohorts 1 & 2, Days 1-7 for single dose of Cohorts 3 & 4, Days 8-31 for multiple doses
Secondary outcomes:
measure: Pharmacokinetics: Maximum Concentration (Cmax) of LY3009104
timeFrame: 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
measure: Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY3009104
timeFrame: 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
measure: Pharmacokinetics: Half-Life(t1/2) of LY3009104
timeFrame: 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
measure: Pharmacokinetics: Apparent Volume of Distribution of LY3009104
timeFrame: 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
measure: Pharmacokinetics: Apparent Total Body Clearance of LY3009104
timeFrame: 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
measure: Pharmacokinetics: Time of Maximum Observed LY3009104 Concentration (Tmax)
timeFrame: 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
measure: Pharmacokinetics: Renal Excretion of LY3009104
timeFrame: Day 1: continuous for 24 hours
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: 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.
state: Hawaii
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: