HealthyPhase 1NCT02482935

A Study of Abemaciclib (LY2835219) in Healthy Participants With and Without Food

A Phase 1 study testing Abemaciclib in people with Healthy, run by Eli Lilly and Company at 2 sites 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

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Abemaciclib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 2 sitesUnited States
Study dates: Jun 2015to Sep 2015
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

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

Who cannot join

Participated in a clinical trial involving investigational product within 30 days
Have known allergies to abemaciclib, related compounds or any components of the formulation, or history of significant atopy
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 milliliter (mL) within the last month

Show all 10Show fewer

Have an average weekly alcohol intake that exceeds 21 units per week (males up to age 65) and 14 units per week (males over 65 and females), or are unwilling to stop alcohol consumption 48 hours prior to each admission until collection of the last PK sample in each period
Are unwilling to refrain from consuming xanthine-containing food and drink from 48 hours prior to admission until collection of the last pharmacokinetic (PK) sample in each period
Are currently or have been smokers or users of tobacco or nicotine replacement products within the 6 months prior to admission or have a positive urine cotinine test
Are unwilling to comply with the dietary requirements/restrictions during the study: Consume only the meals provided during the inpatient stays and refrain from eating any food or drinking any beverages containing grapefruit, grapefruit juice, grapefruit-containing products, Seville oranges, star fruit or star fruit juice, pomelo, or commercial apple juice or orange juice for at least 2 weeks prior to the first dose until the final PK sample is collected

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Covance Clinical Research Unit
Dallas, Texas, 75247
Covance Clinical Research Unit
Daytona Beach, Florida, 32117

Other trials in United States

About this study

Official title: The Effect of Food on the Pharmacokinetics of the Proposed Commercial Formulation of Abemaciclib in Healthy Subjects

The purpose of this study is to evaluate the amount of abemaciclib that reaches the blood stream and how long the body takes to get rid of it when given with and without food. In addition, the safety and tolerability of the study drug will be evaluated. Information about any side effects that may occur will also be collected. The study will last about 43 days for each participant, not including screening.

Conditions: Healthy
Being tested: Abemaciclib

What participants receive

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

AbemaciclibDrug
Also called LY2835219
Administered orally

Study groups in NCT02482935
Study group	Role	What they receive
Abemaciclib High Fat Meal	Experimental	Abemaciclib capsules administered once orally in the fed state. Receives: Drug: Abemaciclib
Abemaciclib Fasted	Experimental	Abemaciclib capsules administered once orally in the fasted state. Receives: Drug: Abemaciclib

What is being measured

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

Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-inf]) for Both Fed and Fasted Periods for Abemaciclib and Major Metabolites
Measured: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose in Each Period
Pharmacokinetics: Maximum Concentration (Cmax) for Both Fed and Fasted Periods for Abemaciclib and Major Metabolites
Measured: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose in Each Period

Secondary outcomes (1)

Pharmacokinetics: Time to Maximum Concentration (Tmax) for Both Fed and Fasted Periods for Abemaciclib and Major Metabolites
Measured: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose in Each Period

Timeline

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

Jun 2015Sep 2015

First posted26 Jun 2015 (estimated)
Study startJun 2015
Primary completionSep 2015
Study completionSep 2015

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 HealthyStudies 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: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02482935
Sponsor's protocol ID: 15536
Other IDs: I3Y-MC-JPBU
Status last verified: Dec 2018
First submitted: 24 Jun 2015
Last updated: 4 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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Study at a glance

From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Food on the Pharmacokinetics of the Proposed Commercial Formulation of Abemaciclib in Healthy Subjects
ClinicalTrials.gov ID: NCT02482935
Acronym / sponsor ID: 15536
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Jun 2015
Primary completion: Sep 2015 (actual)
Study completion: Sep 2015 (actual)
First posted: 26 Jun 2015 (estimated)
Results: Posted 3 Aug 2018

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: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Abemaciclib High Fat Meal	Experimental	Drug: AbemaciclibAbemaciclib capsules administered once orally in the fed state.
Abemaciclib Fasted	Experimental	Drug: AbemaciclibAbemaciclib capsules administered once orally in the fasted state.

Who may qualify

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

Key inclusion criteria (2 listed)

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

Key exclusion criteria (10 listed)

Participated in a clinical trial involving investigational product within 30 days
Have known allergies to abemaciclib, related compounds or any components of the formulation, or history of significant atopy
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

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
AbemaciclibAlso: LY2835219Administered orally	Drug	Abemaciclib Fasted, Abemaciclib High Fat Meal

Primary outcome

Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-inf]) for Both Fed and Fasted Periods for Abemaciclib and Major Metabolites
Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose in Each Period
Pharmacokinetics: Maximum Concentration (Cmax) for Both Fed and Fasted Periods for Abemaciclib and Major Metabolites
Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose in Each Period

1 secondary outcome

Pharmacokinetics: Time to Maximum Concentration (Tmax) for Both Fed and Fasted Periods for Abemaciclib and Major Metabolites
Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose in Each Period

Results and safety

Results posted to the registry on 3 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
Abemaciclib Fasted/Fed	15	14
Abemaciclib Fed/Fasted	15	15

Primary outcome: Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-inf]) for Both Fed and Fasted Periods for Abemaciclib and Major Metabolites

Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose in Each Period. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms x hours/mililiters (ng·h/mL)

Measure	Abemaciclib Fasted n = 27	Abemaciclib Fed n = 29
Abemaciclib	3940 (34)	4950 (42)
LSN2839567	1630 (27)	1910 (28)
LSN3106726	3180 (25)	3410 (28)

Population analysed: All participants who received abemaciclib and had evaluable plasma values.

Primary outcome: Pharmacokinetics: Maximum Concentration (Cmax) for Both Fed and Fasted Periods for Abemaciclib and Major Metabolites

Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose in Each Period. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Abemaciclib Fasted n = 28	Abemaciclib Fed n = 29
Abemaciclib	116 (36)	159 (38)
LSN2839567	33.4 (36)	41.4 (29)
LSN3106726	55.7 (31)	61.0 (29)

Population analysed: All participants who received abemaciclib and had evaluable plasma values.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Abemaciclib Fasted	0 of 30 (0%)	4 of 30 (13.3%)	Not reported
Abemaciclib Fed	0 of 29 (0%)	2 of 29 (6.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 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

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Abemaciclib in people with Healthy, run by Eli Lilly and Company at 2 sites 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 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 4 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 2 sites 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 3 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: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-inf]) for Both Fed and Fasted Periods for Abemaciclib and Major Metabolites (time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose in Each Period). 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 NCT02482935.

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 4 Jan 2019.