A Study of LY3009104(Baricitinib) for Healthy Subjects



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:20 - 65
Updated:4/17/2018
Start Date:November 2010
End Date:April 2011

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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.


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- Are subjects who have previously completed or withdrawn from this study or any other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.
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