A Study of LY3009104(Baricitinib) for Healthy Subjects

NCT01247350 | Completed Phase 1 Results

• 2 other identifiers: 14089I4V-JE-JADM
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Clinically Significant Effects

  Adverse events were considered clinically significant effects. A summary of serious adverse events and other nonserious adverse events are located in the Reported Adverse Event section.

  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 (7)

• Pharmacokinetics: Maximum Concentration (Cmax) of LY3009104

  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

• Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY3009104

  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

• Pharmacokinetics: Half-Life(t1/2) of LY3009104

  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

• Pharmacokinetics: Apparent Volume of Distribution of LY3009104

  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

• Pharmacokinetics: Apparent Total Body Clearance of LY3009104

  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

Study Arms (5)

2 mg LY3009104 (Cohort 1)

EXPERIMENTAL

2mg administered once on day 1 (single dose)

Drug: LY3009104

5 mg LY3009104 (Cohort 2)

EXPERIMENTAL

5mg administered once on day 1 (single dose)

Drug: LY3009104

10 mg LY3009104 (Cohort 3)

EXPERIMENTAL

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

Drug: LY3009104

14 mg LY3009104 (Cohort 4 )

EXPERIMENTAL

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

Drug: LY3009104

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

LY3009104 DRUG

Administered orally

Also known as: baricitinib

10 mg LY3009104 (Cohort 3); 14 mg LY3009104 (Cohort 4 ); 2 mg LY3009104 (Cohort 1); 5 mg LY3009104 (Cohort 2)

Placebo DRUG

Administered orally

Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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

Location

MeSH Terms

Interventions

baricitinib

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2010
• First Posted: November 24, 2010
• Study Start: November 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: April 13, 2018
• Results First Posted: April 13, 2018

Record last verified: 2017-09

Locations

US (1)