Phase 1
Completed N=34
A Study of LY3009104(Baricitinib) for Healthy Subjects
Healthy Volunteer
Source: ClinicalTrials.gov NCT01247350 ↗
Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcomePrimary: Number of Participants With Clinically Significant Effects — 0; 0; 0; 0 Participants
Summary
To evaluate the safety and tolerability of LY3009104 when given orally as single and multiple doses in Japanese healthy subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinically Significant Effects |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Pharmacokinetics: Maximum Concentration (Cmax) of LY3009104 |
76.1; 220; 327; 410; 319; 439 | — |
| SECONDARY Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY3009104 |
403; 1240; 1730; 2790; 1970; 3060 | — |
| SECONDARY Pharmacokinetics: Half-Life(t1/2) of LY3009104 |
5.19; 6.82; 6.43; 8.48; 8.57; 9.41 | — |
| SECONDARY Pharmacokinetics: Apparent Volume of Distribution of LY3009104 |
96.3; 99.4; 138; 150; 169; 167 | — |
| SECONDARY Pharmacokinetics: Apparent Total Body Clearance of LY3009104 |
12.9; 10.1; 14.8; 12.2; 13.7; 12.3 | — |
| SECONDARY Pharmacokinetics: Time of Maximum Observed LY3009104 Concentration (Tmax) |
1.00; 1.00; 1.25; 1.00; 1.00; 1.00 | — |
| SECONDARY Pharmacokinetics: Renal Excretion of LY3009104 |
75.8; 63.6 | — |
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- Are subjects who have previously completed or withdrawn from this study or any other study investigating LY3009104, and received the study drug.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.
Data sourced from ClinicalTrials.gov (NCT01247350). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.