Healthy VolunteersPhase 1NCT01859078

A Drug Drug Interaction (DDI) Study of Baricitinib (LY3009104) and Digoxin in Healthy Participants

A Phase 1 study testing Baricitinib and Digoxin 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 purpose of this study is to determine the effect of baricitinib on the levels of digoxin in the blood stream and how long it takes the body to remove digoxin. This study will also look at how safe and well-tolerated baricitinib is when given at the same time as digoxin in healthy participants. 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 Digoxin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteUnited Kingdom
Study dates: May 2013to Aug 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

Are overtly healthy males or females, as determined by medical history and physical examination
Women not of child-bearing potential
Menopausal women
Have a body mass index of 18.0 to 29.0 kilograms per square meter (kg/m^2)

Who cannot join

Women who are lactating
Have previously completed or withdrawn from this study or any other study investigating baricitinib
Currently enrolled in, have completed or discontinued within the last 90 days from a clinical trial involving an investigational product
Have a pulse rate less than 50 beats per minute (bpm) at screening
Have a current or recent history (less than 30 days prior to screening and/or less than 45 days prior to Day -1) of a clinically significant bacterial, fungal, parasitic, viral (not including rhinopharyngitis), or mycobacterial infection
Have an absolute neutrophil count less than 2000 cells/microliter (2×10^9/liter) at screening or Day -1

Show all 11Show fewer

Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
Have been exposed to a live vaccine within 12 weeks prior to the first dose or expected to need/receive a live vaccine
Intend to use over-the-counter or prescription medication and/or herbal supplements within 14 days prior to dosing and during the study
Have used or intend to use any drugs or substances that are known to be substrates, inducers, or inhibitors of P-glycoprotein (P-gp) within 30 days prior to dosing and throughout the study
Have had symptomatic herpes zoster or herpes simplex infection within 90 days prior to the first dose

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: Effect of Baricitinib on the Pharmacokinetics of Digoxin in Healthy Subjects

Conditions: Healthy Volunteers
Being tested: Baricitinib, Digoxin

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
DigoxinDrug
Administered orally

Study groups in NCT01859078
Study group	Role	What they receive
Baricitinib + Digoxin	Experimental	Digoxin - 0.5 milligrams (mg) administered orally, twice daily (BID), 12 hours apart on Day 1. Then, 0.25 mg administered orally, once daily (QD) on Days 2 through 16. Baricitinib - 10 mg administered orally, QD, on Days 8 through 16. Receives: Drug: Baricitinib; Drug: Digoxin

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 During 1 Dosing Interval (AUCτ) of Digoxin
Measured: Predose up to 24 hours post-dose on Days 7 and 16
PK: Maximum Concentration (Cmax) of Digoxin
Measured: Predose up to 24 hours post-dose on Days 7 and 16
PK: Time of Maximum Observed Drug Concentration (Tmax) of Digoxin
Measured: Predose up to 24 hours post-dose on Days 7 and 16

Secondary outcomes (2)

PK: Amount of Drug Excreted Unchanged During 1 Dosing Interval (Aeτ) of Digoxin
Measured: 0 to 24 hours post-dose on Days 7 and 16
PK: Renal Clearance (CLr) of Digoxin
CLr is the volume of plasma from which study drug is completely removed by the kidney in a given time and is calculated as Aeτ divided by AUCτ.
Measured: Predose to 24 hours post-dose on Days 7 and 16

Timeline

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

May 2013Aug 2013

First posted21 May 2013 (estimated)
Study startMay 2013
Primary completionAug 2013
Study completionAug 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01859078
Sponsor's protocol ID: 14609
Other IDs: I4V-MC-JAGL
Status last verified: May 2017
First submitted: 17 May 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?

See locations

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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: Effect of Baricitinib on the Pharmacokinetics of Digoxin in Healthy Subjects
ClinicalTrials.gov ID: NCT01859078
Acronym / sponsor ID: 14609
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: May 2013
Primary completion: Aug 2013 (actual)
Study completion: Aug 2013 (actual)
First posted: 21 May 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Baricitinib + Digoxin	Experimental	Drug: Baricitinib, Drug: DigoxinDigoxin - 0.5 milligrams (mg) administered orally, twice daily (BID), 12 hours apart on Day 1. Then, 0.25 mg administered orally, once daily (QD) on Days 2 through 16. Baricitinib - 10 mg administered orally, QD, on Days 8 through 16.

Who may qualify

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

Key inclusion criteria (4 listed)

Are overtly healthy males or females, as determined by medical history and physical examination
Women not of child-bearing potential
Menopausal women
Have a body mass index of 18.0 to 29.0 kilograms per square meter (kg/m^2)

Key exclusion criteria (11 listed)

Women who are lactating
Have previously completed or withdrawn from this study or any other study investigating baricitinib
Currently enrolled in, have completed or discontinued within the last 90 days from a clinical trial involving an investigational product
Have a pulse rate less than 50 beats per minute (bpm) at screening
Have a current or recent history (less than 30 days prior to screening and/or less than 45 days prior to Day -1) of a clinically significant bacterial, fungal, parasitic, viral (not including rhinopharyngitis), or mycobacterial infection

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 + Digoxin
DigoxinAdministered orally	Drug	Baricitinib + Digoxin

Primary outcome

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUCτ) of Digoxin
Time frame: Predose up to 24 hours post-dose on Days 7 and 16
PK: Maximum Concentration (Cmax) of Digoxin
Time frame: Predose up to 24 hours post-dose on Days 7 and 16
PK: Time of Maximum Observed Drug Concentration (Tmax) of Digoxin
Time frame: Predose up to 24 hours post-dose on Days 7 and 16

2 secondary outcomes

PK: Amount of Drug Excreted Unchanged During 1 Dosing Interval (Aeτ) of Digoxin
Time frame: 0 to 24 hours post-dose on Days 7 and 16
PK: Renal Clearance (CLr) of Digoxin
Time frame: Predose to 24 hours post-dose on Days 7 and 16

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
Baricitinib + Digoxin	28	28

Primary outcome: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUCτ) of Digoxin

Time frame: Predose up to 24 hours post-dose on Days 7 and 16. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms*hour/milliliter (ng*h/mL)

Measure	Digoxin Only n = 28	Baricitinib + Digoxin n = 28
Value	18.7 (18)	16.8 (20)

Population analysed: All enrolled participants who received study drug and had PK data to calculate AUCτ. Participants were analyzed based on the treatment they received.

Primary outcome: PK: Maximum Concentration (Cmax) of Digoxin

Time frame: Predose up to 24 hours post-dose on Days 7 and 16. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms/milliliter (ng/mL)

Measure	Digoxin Only n = 28	Baricitinib + Digoxin n = 28
Value	2.04 (23)	1.80 (20)

Population analysed: All enrolled participants who received study drug and had PK data to calculate Cmax. Participants were analyzed based on the treatment they received.

Primary outcome: PK: Time of Maximum Observed Drug Concentration (Tmax) of Digoxin

Time frame: Predose up to 24 hours post-dose on Days 7 and 16. Median (Full Range). Unit: hours (h)

Measure	Digoxin Only n = 28	Baricitinib + Digoxin n = 28
Value	1.00 (0.50 to 2.00)	1.00 (0.42 to 2.00)

Population analysed: All enrolled participants who received study drug and had PK data to calculate tmax. Participants were analyzed based on the treatment they received.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Digoxin Only	0 of 28 (0%)	10 of 28 (35.7%)	Not reported
Baricitinib + Digoxin	0 of 28 (0%)	6 of 28 (21.4%)	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 Digoxin 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 4 inclusion and 11 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): Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUCτ) of Digoxin (time frame: Predose up to 24 hours post-dose on Days 7 and 16). 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?

On the ClinicalTrials.gov record for NCT01859078.

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.