A Study of LY3009104(Baricitinib) for Healthy Subjects

NCT ID: NCT01247350

Last Updated: 2018-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2011-04-30

Brief Summary

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

Conditions

Healthy Volunteer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

2 mg LY3009104 (Cohort 1)

2mg administered once on day 1 (single dose)

Group Type: EXPERIMENTAL

LY3009104

Intervention Type: DRUG

Administered orally

5 mg LY3009104 (Cohort 2)

5mg administered once on day 1 (single dose)

Group Type: EXPERIMENTAL

LY3009104

Intervention Type: DRUG

Administered orally

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)

Group Type: EXPERIMENTAL

LY3009104

Intervention Type: DRUG

Administered orally

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)

Group Type: EXPERIMENTAL

LY3009104

Intervention Type: DRUG

Administered orally

Placebo

administered on day 1 (single dose) and following a 7 day washout period, administered once daily for 10 days (multiple dose)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered orally

Interventions

LY3009104

Administered orally

Intervention Type: DRUG

Placebo

Administered orally

Intervention Type: DRUG

Other Intervention Names

baricitinib

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Eli Lilly and Company

Locations

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

Countries

United States

Other Identifiers

I4V-JE-JADM

Identifier Type: OTHER

Identifier Source: secondary_id

14089

Identifier Type: -

Identifier Source: org_study_id