Healthy ParticipantsPhase 1NCT02263911
A Study of Baricitinib in Healthy Japanese Participants
A Phase 1 study testing Baricitinib in people with Healthy Participants, run by Eli Lilly and Company at 1 site in Japan.
Trial summary
The purpose of this study is to understand the relationship of 3 different dosage forms of baricitinib. This study will also explore the effect of food on how the body absorbs baricitinib. This study will last about 5 weeks, not including screening. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Baricitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2014to Dec 2014
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overtly healthy Japanese male and female (women not of child-bearing potential or after menopause), as determined by medical history and physical examination
- Have a body mass index (BMI) of 18.5 to 29.9 kilogram per square meter (kg/m^2)
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
Who cannot join
- Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
- Have an abnormal blood pressure as determined by the investigator
- 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
- Are women who are pregnant or lactating
- Have used or intend to use over-the-counter or prescription medication, including herbal medications, within 14 days prior to dosing and during the study.
- Have donated blood of more than 400 milliliter (mL) in the last 12 weeks (males) or in the last 16 weeks (females), or any blood donation (including apheresis) within the last 4 weeks, or total volume of blood donation within 12 months is 1200 mL (males) or 800 mL (females) at screening.
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- Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females), or are unwilling to abide by alcohol restrictions
- Are participants who currently smoke more than 10 cigarettes per day (or equivalent in tobacco or nicotine products) or are unwilling to abide by smoking restrictions
- Have a current or recent history of a clinically significant bacterial, fungal, parasitic, viral (not including rhinopharyngitis), or mycobacterial infection
- Have an absolute neutrophil count (ANC) less than 2000 cells/microliter (µL)
Trial locations and contacts
1 site in 1 country.
Japan1 site
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.
Hachiōji, Tokyo, 192-0071
About this study
Official title: Relative Bioavailability of the Baricitinib (LY3009104) Commercial Tablet Compared to the Phase 2 Tablets and the Effect of Food on the Bioavailability of the Commercial Tablet in Healthy Japanese Subjects
The purpose of this study is to understand the relationship of 3 different dosage forms of baricitinib. This study will also explore the effect of food on how the body absorbs baricitinib. This study will last about 5 weeks, not including screening. Screening is required within 28 days prior to the date of first dosing.
- Conditions
- Healthy Participants
- Being tested
- Baricitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaricitinibDrug
Also called LY3009104
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Baricitinib Test Treatment 1 (T1) | Experimental | Single oral dose of 2 × 4 milligram (mg) baricitinib commercial formulation tablet fasted on Day 1 in one of five periods. Receives: Drug: Baricitinib |
| Baricitinib Reference Treatment 1 (R1) | Experimental | Single oral dose of 1 × 8 mg baricitinib Phase 2 tablet fasted on Day 1 in one of five periods. Receives: Drug: Baricitinib |
| Baricitinib Test Treatment 2 (T2) | Experimental | Single oral dose of 1 × 4 mg baricitinib commercial formulation tablet fasted on Day 1 in one of five periods. Receives: Drug: Baricitinib |
| Baricitinib Reference Treatment 2 (R2) | Experimental | Single oral dose of 1 × 4 mg baricitinib Phase 2 tablet fasted on Day 1 in one of five periods. Receives: Drug: Baricitinib |
| Baricitinib Test Treatment 2 with Meal (T2F) | Experimental | Single oral dose of 1 × 4 mg baricitinib commercial formulation tablet after food intake on Day 1 in one of five periods. Receives: Drug: Baricitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Baricitinib
Measured: Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 Hours Post-dose
PK: Area Under the Concentration Versus Time Curve From Zero to Last Measurable Concentration (AUC[0-tlast]) of Baricitinib
Measured: Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 Hours Post-dose
PK: Maximum Concentration (Cmax) of Baricitinib
Measured: Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 Hours Post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02263911
- Sponsor's protocol ID
- 14612
- Other IDs
- I4V-MC-JAGO
- Status last verified
- May 2017
- First submitted
- 8 Oct 2014
- Last updated
- 6 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Bioavailability of the Baricitinib (LY3009104) Commercial Tablet Compared to the Phase 2 Tablets and the Effect of Food on the Bioavailability of the Commercial Tablet in Healthy Japanese Subjects
- ClinicalTrials.gov ID
- NCT02263911
- Acronym / sponsor ID
- 14612
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 Oct 2014 (estimated)
- Results
- Posted 21 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to understand the relationship of 3 different dosage forms of baricitinib. This study will also explore the effect of food on how the body absorbs baricitinib. This study will last about 5 weeks, not including screening. Screening is required within 28 days prior to the date of first dosing.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Baricitinib Test Treatment 1 (T1) | Experimental | Drug: BaricitinibSingle oral dose of 2 × 4 milligram (mg) baricitinib commercial formulation tablet fasted on Day 1 in one of five periods. |
| Baricitinib Reference Treatment 1 (R1) | Experimental | Drug: BaricitinibSingle oral dose of 1 × 8 mg baricitinib Phase 2 tablet fasted on Day 1 in one of five periods. |
| Baricitinib Test Treatment 2 (T2) | Experimental | Drug: BaricitinibSingle oral dose of 1 × 4 mg baricitinib commercial formulation tablet fasted on Day 1 in one of five periods. |
| Baricitinib Reference Treatment 2 (R2) | Experimental | Drug: BaricitinibSingle oral dose of 1 × 4 mg baricitinib Phase 2 tablet fasted on Day 1 in one of five periods. |
| Baricitinib Test Treatment 2 with Meal (T2F) | Experimental | Drug: BaricitinibSingle oral dose of 1 × 4 mg baricitinib commercial formulation tablet after food intake on Day 1 in one of five periods. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Overtly healthy Japanese male and female (women not of child-bearing potential or after menopause), as determined by medical history and physical examination
- Have a body mass index (BMI) of 18.5 to 29.9 kilogram per square meter (kg/m^2)
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
Key exclusion criteria (10 listed)
- Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
- Have an abnormal blood pressure as determined by the investigator
- 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
- Are women who are pregnant or lactating
- Have used or intend to use over-the-counter or prescription medication, including herbal medications, within 14 days prior to dosing and during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BaricitinibAlso: LY3009104Administered orally | Drug | Baricitinib Reference Treatment 1 (R1), Baricitinib Reference Treatment 2 (R2), Baricitinib Test Treatment 1 (T1), Baricitinib Test Treatment 2 (T2), Baricitinib Test Treatment 2 with Meal (T2F) |
Primary outcome
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Baricitinib
Time frame: Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 Hours Post-dose
PK: Area Under the Concentration Versus Time Curve From Zero to Last Measurable Concentration (AUC[0-tlast]) of Baricitinib
Time frame: Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 Hours Post-dose
PK: Maximum Concentration (Cmax) of Baricitinib
Time frame: Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 Hours Post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Baricitinib in people with Healthy Participants, run by Eli Lilly and Company at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Baricitinib (time frame: Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 Hours Post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2017.