A Study of LY3009104(Baricitinib) for Healthy Subjects

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: LY3009104; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01247350

14089

I4V-JE-JADM (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 34 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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• Are subjects who have previously completed or withdrawn from this study or any other study investigating LY3009104, and received the study drug.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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 5 patient groups, including a placebo group

2 mg LY3009104 (Cohort 1)

Experimental group

Description:

2mg administered once on day 1 (single dose)

Treatment:

Drug: LY3009104

5 mg LY3009104 (Cohort 2)

Experimental group

Description:

5mg administered once on day 1 (single dose)

Treatment:

Drug: LY3009104

10 mg LY3009104 (Cohort 3)

Experimental group

Description:

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

Treatment:

Drug: LY3009104

14 mg LY3009104 (Cohort 4 )

Experimental group

Description:

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

Treatment:

Drug: LY3009104

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo