Healthy VolunteersPhase 1NCT02256267

A Study of LY2835219 in Healthy Participants

A Phase 1 study testing LY2835219 and Rifampin in people with Healthy Volunteers, run by Eli Lilly and Company at 1 site in United States.

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 aim of this two-period study is to compare how much of the study drug gets into the blood stream when it is given as a single oral dose and when it is given as a single oral dose in combination with rifampin (a Food and Drug Administration [FDA] approved antibiotic that is used to treat tuberculosis, a bacterial… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: LY2835219 and Rifampin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: Oct 2014to Nov 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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Overtly healthy sterile males or surgically sterile females or postmenopausal females
Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m^2)

Who cannot join

Have participated in a clinical trial involving investigational product within the last 30 days
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
Show evidence of human immunodeficiency virus (HIV), hepatitis B or hepatitis C
Have donated blood of more than 500 milliliters (mL) within the last month
Have used or intend to use over-the-counter or prescription medication including herbal medications within 7 days prior to dosing or during the study

Trial locations and contacts

1 site in 1 country.

United States1 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.
Dallas, Texas, 75247

Other trials in United States

About this study

Official title: Effects of CYP3A Induction by Rifampin on the Pharmacokinetics of LY2835219 and Its Metabolites in Healthy Subjects

The study will last about 34 days. Screening is required within 28 days before study drug is given.

Conditions: Healthy Volunteers
Being tested: LY2835219, Rifampin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY2835219Drug
Also called abemaciclib
Administered orally
RifampinDrug
Administered orally

Study groups in NCT02256267
Study group	Role	What they receive
LY2835219	Experimental	Single oral dose of LY2835219 Receives: Drug: LY2835219
LY2835219 + Rifampin	Experimental	Single oral dose of LY2835219 with rifampin orally, once daily for 14 days Receives: Drug: LY2835219; Drug: Rifampin

What is being measured

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

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2835219
Measured: Period 1: Day 1- Predose,1, 2, 4, 6, 8, 10 hours, Days 2-9: 24, 48, 72, 96, 120, 144, 168, and 192 hours; Period 2: Day 7- Predose,1, 2, 4, 6, 8, 10 hours, Days 8-15: 24, 48, 72, 96, 120, 144, 168, 192 hours
PK: Area Under the Concentration Time Curve AUC(0-∞) of LY2835219
Measured: Period 1: Day 1- Predose,1, 2, 4, 6, 8, 10 hours, Days 2-9: 24, 48, 72, 96, 120, 144, 168, and 192 hours; Period 2: Day 7- Predose,1, 2, 4, 6, 8, 10 hours, Days 8-15: 24, 48, 72, 96, 120, 144, 168, 192 hours

Timeline

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

Oct 2014Nov 2014

First posted3 Oct 2014 (estimated)
Study startOct 2014
Primary completionNov 2014
Study completionNov 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 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: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02256267
Sponsor's protocol ID: 15174
Other IDs: I3Y-MC-JPBF
Status last verified: Dec 2018
First submitted: 1 Oct 2014
Last updated: 7 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Expanded access: Available

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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All Healthy Volunteers trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of CYP3A Induction by Rifampin on the Pharmacokinetics of LY2835219 and Its Metabolites in Healthy Subjects
ClinicalTrials.gov ID: NCT02256267
Acronym / sponsor ID: 15174
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Oct 2014
Primary completion: Nov 2014 (actual)
Study completion: Nov 2014 (actual)
First posted: 3 Oct 2014 (estimated)
Results: Posted 2 Aug 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study will last about 34 days. Screening is required within 28 days before study drug is given.

Study design

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

Arm	Type	Receives
LY2835219	Experimental	Drug: LY2835219Single oral dose of LY2835219
LY2835219 + Rifampin	Experimental	Drug: LY2835219, Drug: RifampinSingle oral dose of LY2835219 with rifampin orally, once daily for 14 days

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Overtly healthy sterile males or surgically sterile females or postmenopausal females
Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m^2)

Key exclusion criteria (6 listed)

Have participated in a clinical trial involving investigational product within the last 30 days
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
Show evidence of human immunodeficiency virus (HIV), hepatitis B or hepatitis C
Have donated blood of more than 500 milliliters (mL) within the last month

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
LY2835219Also: abemaciclibAdministered orally	Drug	LY2835219, LY2835219 + Rifampin
RifampinAdministered orally	Drug	LY2835219 + Rifampin

Primary outcome

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2835219
Time frame: Period 1: Day 1- Predose,1, 2, 4, 6, 8, 10 hours, Days 2-9: 24, 48, 72, 96, 120, 144, 168, and 192 hours; Period 2: Day 7- Predose,1, 2, 4, 6, 8, 10 hours, Days 8-15: 24, 48, 72, 96, 120, 144, 168, 192 hours
PK: Area Under the Concentration Time Curve AUC(0-∞) of LY2835219
Time frame: Period 1: Day 1- Predose,1, 2, 4, 6, 8, 10 hours, Days 2-9: 24, 48, 72, 96, 120, 144, 168, and 192 hours; Period 2: Day 7- Predose,1, 2, 4, 6, 8, 10 hours, Days 8-15: 24, 48, 72, 96, 120, 144, 168, 192 hours

Results and safety

Results posted to the registry on 2 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LY2835219 Then LY2835219 + Rifampin	24	23

Primary outcome: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2835219

Time frame: Period 1: Day 1- Predose,1, 2, 4, 6, 8, 10 hours, Days 2-9: 24, 48, 72, 96, 120, 144, 168, and 192 hours; Period 2: Day 7- Predose,1, 2, 4, 6, 8, 10 hours, Days 8-15: 24, 48, 72, 96, 120, 144, 168, 192 hours. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram per milliliter (ng/ml)

Measure	200 mg LY2835219 n = 24	200 mg LY2835219 + 600 mg Rifampin n = 21
Value	134 (45)	10.5 (58)

200 mg LY2835219 vs 200 mg LY2835219 + 600 mg Rifampin: Ratio of Geometric Least Squares Means: 0.0771 (90% CI 0.0671 to 0.0886)

Population analysed: All participants who received at least 1 dose of study drug and have evaluable PK data.

Primary outcome: PK: Area Under the Concentration Time Curve AUC(0-∞) of LY2835219

Measure	200 mg LY2835219 n = 24	200 mg LY2835219 + 600 mg Rifampin n = 14
Value	4570 (53)	229 (48)

200 mg LY2835219 vs 200 mg LY2835219 + 600 mg Rifampin: Ratio of Geometric Least Squares Means: 0.0467 (90% CI 0.0376 to 0.0581)

Population analysed: All participants who received at least 1 dose of study drug and have evaluable PK data.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LY2835219	0 of 24 (0%)	8 of 24 (33.3%)	Not reported
Rifampin	0 of 23 (0%)	2 of 23 (8.7%)	Not reported
LY2835219 + Rifampin	1 of 23 (4.3%)	4 of 23 (17.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2019.
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 LY2835219 and Rifampin in people with Healthy Volunteers, run by Eli Lilly and Company at 1 site in United States.

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 2 inclusion and 6 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 7 Jan 2019. 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 States. 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 2 Aug 2018). 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 LY2835219 (time frame: Period 1: Day 1- Predose,1, 2, 4, 6, 8, 10 hours, Days 2-9: 24, 48, 72, 96, 120, 144, 168, and 192 hours; Period 2: Day 7- Predose,1, 2, 4, 6, 8, 10 hours, Days 8-15: 24, 48, 72, 96, 120, 144, 168, 192 hours). 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 NCT02256267.

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 7 Jan 2019; AzTrials last refreshed its copy on 7 Nov 2026.