Healthy VolunteersPhase 1NCT01960140

A Study of Baricitinib and Simvastatin in Healthy Participants

A Phase 1 study testing Baricitinib and Simvastatin in people with Healthy Volunteers, run by Eli Lilly and Company at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purposes of this study are to determine the effects of baricitinib on the time it takes to remove simvastatin from the body and to look at how well-tolerated and safe baricitinib is when given alone and in combination with simvastatin. Side effects will be documented. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Baricitinib and Simvastatin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited Kingdom
Study dates: Oct 2013to Dec 2013
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 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male participants - Agree to use 2 reliable methods of birth control with female partners of childbearing potential during the study and for at least 3 months following the last dose of study drug
Female participants - Women not of childbearing potential due to surgical sterilization confirmed by medical history, or menopause
Have a body mass index of 18.0 to 29.0 kilograms per meter squared (kg/m^2), inclusive
Have clinical laboratory test results within the normal reference range
Have normal renal function
Have normal blood pressure and pulse rate

Who cannot join

Are currently enrolled in a clinical trial involving a study drug or off-label use of a drug or device, or are concurrently enrolled in any other type of medical research
Have completed or discontinued within the last 90 days from a clinical trial involving a study drug
Have previously completed or withdrawn from this study or any other study investigating baricitinib, and have previously received baricitinib
Have known allergies to baricitinib, simvastatin, related compounds, or any components of the baricitinib or simvastatin formulations, or history of significant atopy
Have an abnormality in the 12-lead electrocardiogram (ECG)
Have a history of, or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (including hypothyroidism), hematological, or neurological disorders

Show all 22Show fewer

Have current or recent history of myalgia or muscle weakness
Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
Have a current or recent history of a clinically significant bacterial, fungal, parasitic, viral (not including rhinopharyngitis), or mycobacterial infection
Have had symptomatic herpes zoster or herpes simplex infection within 90 days prior to the first dose
Have an absolute neutrophil count (ANC) less than 2 × 10^9/liters (L) [2000 cells/microliter (μL)] at screening or day prior to first dose of study drug. For abnormal values, a single repeat will be allowed
Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
Show evidence of hepatitis C infection and/or positive hepatitis C antibody
Show evidence of hepatitis B infection and/or positive hepatitis B surface antigen
Are women who are lactating
Have been exposed to a live vaccine within 12 weeks prior to the first dose or expected to need/receive a live vaccine (including herpes zoster vaccination) during the course of the study
Intend to use over-the-counter or prescription medication (including salicylate drugs) and/or herbal supplements within 14 days prior to dosing and during the study or intended use of vitamin supplements from Day 1 until discharge from the Clinical Research Unit (CRU)
Have consumed or intend to consume grapefruit or grapefruit-containing products within 14 days prior to the first dose and throughout the study
Have donated or lost blood of more than 500 milliliters (mL) within the last 3 months
Have an average weekly alcohol intake that exceeds 28 units per week (males) and 21 units per week (females), or are unwilling to stop alcohol consumption from 48 hours prior to the first dose until discharge from the CRU at the end of Period 2
History of, in the opinion of the investigator, excessive methylxanthine use within the previous 6 months, such as greater than (>)6 cups of coffee (or equivalent) per day
Currently smoke more than 10 cigarettes per day

Trial locations and contacts

1 site in 1 country.

United Kingdom1 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.
Leeds, West Yorkshire, LS2 9LH

Other trials in United Kingdom

About this study

Official title: Effects of Multiple Baricitinib (LY3009104) Doses on the Pharmacokinetics of a Cytochrome P450 3A Substrate, Simvastatin, in Healthy Subjects

Conditions: Healthy Volunteers
Being tested: Baricitinib, Simvastatin

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
SimvastatinDrug
Administered orally

Study groups in NCT01960140
Study group	Role	What they receive
Simvastatin	Experimental	Single oral dose of 40 milligrams (mg) simvastatin on Day 1. Receives: Drug: Simvastatin
Baricitinib + Simvastatin	Experimental	Oral doses of 10 mg baricitinib once daily (QD) on Days 3 to 7, with a single oral dose of 40 mg simvastatin coadministered on Day 6. Receives: Drug: Baricitinib; Drug: Simvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Simvastatin and Simvastatin Acid
The Cmax of simvastatin [a cytochrome P450 (CYP) 3A substrate] and its active acid metabolite (simvastatin acid) is reported.
Measured: Period 1, Day 1 and Period 2, Day 6: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 48 hours postdose
PK: Area Under the Concentration Versus Time Curve From Zero to Infinity [AUC(0-∞)] of Simvastatin and Simvastatin Acid
The AUC(0-∞) of simvastatin (a CYP3A substrate) and its active acid metabolite (simvastatin acid) is reported.
Measured: Period 1, Day 1 and Period 2, Day 6: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 48 hours postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2013Dec 2013

First posted10 Oct 2013 (estimated)
Study startOct 2013
Primary completionDec 2013
Study completionDec 2013

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 VolunteersStudies 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01960140
Sponsor's protocol ID: 14606
Other IDs: I4V-MC-JAGI
Status last verified: May 2017
First submitted: 8 Oct 2013
Last updated: 6 Jun 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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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: Effects of Multiple Baricitinib (LY3009104) Doses on the Pharmacokinetics of a Cytochrome P450 3A Substrate, Simvastatin, in Healthy Subjects
ClinicalTrials.gov ID: NCT01960140
Acronym / sponsor ID: 14606
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Oct 2013
Primary completion: Dec 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 10 Oct 2013 (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.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Simvastatin	Experimental	Drug: SimvastatinSingle oral dose of 40 milligrams (mg) simvastatin on Day 1.
Baricitinib + Simvastatin	Experimental	Drug: Baricitinib, Drug: SimvastatinOral doses of 10 mg baricitinib once daily (QD) on Days 3 to 7, with a single oral dose of 40 mg simvastatin coadministered on Day 6.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Male participants - Agree to use 2 reliable methods of birth control with female partners of childbearing potential during the study and for at least 3 months following the last dose of study drug
Female participants - Women not of childbearing potential due to surgical sterilization confirmed by medical history, or menopause
Have a body mass index of 18.0 to 29.0 kilograms per meter squared (kg/m^2), inclusive
Have clinical laboratory test results within the normal reference range
Have normal renal function

Key exclusion criteria (22 listed)

Are currently enrolled in a clinical trial involving a study drug or off-label use of a drug or device, or are concurrently enrolled in any other type of medical research
Have completed or discontinued within the last 90 days from a clinical trial involving a study drug
Have previously completed or withdrawn from this study or any other study investigating baricitinib, and have previously received baricitinib
Have known allergies to baricitinib, simvastatin, related compounds, or any components of the baricitinib or simvastatin formulations, or history of significant atopy
Have an abnormality in the 12-lead electrocardiogram (ECG)

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 + Simvastatin
SimvastatinAdministered orally	Drug	Baricitinib + Simvastatin, Simvastatin

Primary outcome

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Simvastatin and Simvastatin Acid
Time frame: Period 1, Day 1 and Period 2, Day 6: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 48 hours postdose
The Cmax of simvastatin [a cytochrome P450 (CYP) 3A substrate] and its active acid metabolite (simvastatin acid) is reported.
PK: Area Under the Concentration Versus Time Curve From Zero to Infinity [AUC(0-∞)] of Simvastatin and Simvastatin Acid
Time frame: Period 1, Day 1 and Period 2, Day 6: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 48 hours postdose
The AUC(0-∞) of simvastatin (a CYP3A substrate) and its active acid metabolite (simvastatin acid) is reported.

Results and safety

Results posted to the registry on 21 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Simvastatin Then Baricitinib and Simvastatin	40	40

Primary outcome: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Simvastatin and Simvastatin Acid

Time frame: Period 1, Day 1 and Period 2, Day 6: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 48 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms per milliliter (ng/mL)

Measure	Simvastatin n = 40	Baricitinib and Simvastatin n = 38
Simvastatin	6.85 (74)	4.65 (57)
Simvastatin Acid	1.93 (68)	1.60 (50)

Population analysed: Participants who received study drug (simvastatin in Period 1 and at least 1 dose of baricitinib and simvastatin in Period 2) and had evaluable PK data.

Primary outcome: PK: Area Under the Concentration Versus Time Curve From Zero to Infinity [AUC(0-∞)] of Simvastatin and Simvastatin Acid

Measure	Simvastatin n = 39	Baricitinib and Simvastatin n = 36
Simvastatin (n=39, 36)	40.7 (86)	33.7 (75)
Simvastatin Acid (n=33, 32)	26.4 (81)	21.0 (64)

Population analysed: Participants who received study drug (simvastatin in Period 1 and at least 1 dose of baricitinib and simvastatin in Period 2) and had evaluable PK data.

Adverse events

Time frame: Baseline through study completion (up to Day 18). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Simvastatin	0 of 40 (0%)	3 of 40 (7.5%)	Not reported
Baricitinib	0 of 40 (0%)	1 of 40 (2.5%)	Not reported
Baricitinib and Simvastatin	0 of 38 (0%)	3 of 38 (7.9%)	Not reported

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 and Simvastatin in people with Healthy Volunteers, run by Eli Lilly and Company at 1 site in United Kingdom.

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 6 inclusion and 22 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 United Kingdom. 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): Maximum Concentration (Cmax) of Simvastatin and Simvastatin Acid (time frame: Period 1, Day 1 and Period 2, Day 6: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 48 hours postdose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01960140.

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.