HealthyPhase 1NCT02672423

A Study of Abemaciclib in Healthy Participants

A Phase 1 study testing Abemaciclib Capsules (Reference Formulation) and Abemaciclib Tablet (Test Formulation) 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 Capsules (Reference Formulation) and Abemaciclib Tablet (Test Formulation)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 127 participants
Where: 2 sitesUnited States
Study dates: Feb 2016to Oct 2016
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

Healthy surgically sterile or postmenopausal females and sterile males
Have a body mass index (BMI) 18 to 32 kilograms per square meter (kg/m²)

Who cannot join

Have known allergies to abemaciclib, related compounds, or any components of the formulation
Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
Show evidence of hepatitis C and/or positive hepatitis C antibody
Show evidence of hepatitis B and/or positive hepatitis B surface antigen

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Daytona Beach Clinical Research Unit
Daytona Beach, Florida, 32117
Evansville Clinical Research Unit
Evansville, Indiana, 47710

Other trials in United States

About this study

Official title: A Bioequivalence Study Comparing Abemaciclib Capsule and Tablet Formulations and Effect of Food on Abemaciclib Tablet Pharmacokinetics in Healthy Subjects

The purpose of this study is to measure how much abemaciclib gets into the blood stream and how long it takes the body to get rid of it when given as capsules versus a tablet(s). The effect of a high fat meal on the tablet formulation will also be evaluated. In addition, the tolerability of abemaciclib tablet and capsule formulations will be evaluated. Information about any side effects that may occur will also be collected.

This study has 3 parts. Parts A and C will last about 44 days including follow-up. Part B will last about 60 days including follow-up. Screening may occur up to 28 days before the first dose of study drug. Participants are only allowed to enroll in one part.

This study is for research purposes only and is not intended to treat any medical condition.

Conditions: Healthy
Being tested: Abemaciclib Capsules (Reference Formulation), Abemaciclib Tablet (Test Formulation)

What participants receive

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

Abemaciclib Capsules (Reference Formulation)Drug
Also called LY2835219
Administered orally
Abemaciclib Tablet (Test Formulation)Drug
Also called LY2835219
Administered orally

Study groups in NCT02672423
Study group	Role	What they receive
Abemaciclib Part A	Experimental	Reference formulation (R) = 3 x 50 mg abemaciclib capsules, Test formulation (T150) = 150 mg abemaciclib tablet administered orally on Day 1 in each of 2 periods. Receives: Drug: Abemaciclib Capsules (Reference Formulation); Drug: Abemaciclib Tablet (Test Formulation)
Abemaciclib Part B	Experimental	R = 3 x 50 mg abemaciclib capsules, T150 = 150 mg abemaciclib tablet, Test Formulation 50 (T50) = 3 x 50 mg abemaciclib tablets administered orally on Day 1 in each of 3 periods. Receives: Drug: Abemaciclib Capsules (Reference Formulation); Drug: Abemaciclib Tablet (Test Formulation)
Abemaciclib Part C	Experimental	T150 Fed and T150 Fasted = 150 mg abemaciclib tablet with a high-fat meal (T150 Fed) and then without a high-fat meal (T150 Fasted) on Day 1 in each of 2 periods administered orally. Receives: Drug: Abemaciclib Tablet (Test Formulation)

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-∞])
Area under the concentration versus time curve from zero to infinity.
Measured: Parts A and C Periods 1 and 2; Part B Periods 1, 2, 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 96, 120,144,168 and 192 hours postdose
PK: Maximum Observed Drug Concentration (Cmax)
Maximum observed drug concentration.
Measured: Parts A and C Periods 1 and 2; Part B Periods 1, 2, 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 96, 120,144,168 and 192 hours postdose

Timeline

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

Feb 2016Oct 2016

First posted3 Feb 2016 (estimated)
Study startFeb 2016
Primary completionOct 2016
Study completionOct 2016

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: 127 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02672423
Sponsor's protocol ID: 16169
Other IDs: I3Y-MC-JPCC
Status last verified: Dec 2018
First submitted: 1 Feb 2016
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: A Bioequivalence Study Comparing Abemaciclib Capsule and Tablet Formulations and Effect of Food on Abemaciclib Tablet Pharmacokinetics in Healthy Subjects
ClinicalTrials.gov ID: NCT02672423
Acronym / sponsor ID: 16169
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 127 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Feb 2016
Primary completion: Oct 2016 (actual)
Study completion: Oct 2016 (actual)
First posted: 3 Feb 2016 (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.

This study is for research purposes only and is not intended to treat any medical condition.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Abemaciclib Part A	Experimental	Drug: Abemaciclib Capsules (Reference Formulation), Drug: Abemaciclib Tablet (Test Formulation)Reference formulation (R) = 3 x 50 mg abemaciclib capsules, Test formulation (T150) = 150 mg abemaciclib tablet administered orally on Day 1 in each of 2 periods.
Abemaciclib Part B	Experimental	Drug: Abemaciclib Capsules (Reference Formulation), Drug: Abemaciclib Tablet (Test Formulation)R = 3 x 50 mg abemaciclib capsules, T150 = 150 mg abemaciclib tablet, Test Formulation 50 (T50) = 3 x 50 mg abemaciclib tablets administered orally on Day 1 in each of 3 periods.
Abemaciclib Part C	Experimental	Drug: Abemaciclib Tablet (Test Formulation)T150 Fed and T150 Fasted = 150 mg abemaciclib tablet with a high-fat meal (T150 Fed) and then without a high-fat meal (T150 Fasted) on Day 1 in each of 2 periods administered orally.

Who may qualify

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

Key inclusion criteria (2 listed)

Healthy surgically sterile or postmenopausal females and sterile males
Have a body mass index (BMI) 18 to 32 kilograms per square meter (kg/m²)

Key exclusion criteria (5 listed)

Have known allergies to abemaciclib, related compounds, or any components of the formulation
Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
Show evidence of hepatitis C and/or positive hepatitis C antibody
Show evidence of hepatitis B and/or positive hepatitis B surface antigen

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
Abemaciclib Capsules (Reference Formulation)Also: LY2835219Administered orally	Drug	Abemaciclib Part A, Abemaciclib Part B
Abemaciclib Tablet (Test Formulation)Also: LY2835219Administered orally	Drug	Abemaciclib Part A, Abemaciclib Part B, Abemaciclib Part C

Primary outcome

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞])
Time frame: Parts A and C Periods 1 and 2; Part B Periods 1, 2, 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 96, 120,144,168 and 192 hours postdose
Area under the concentration versus time curve from zero to infinity.
PK: Maximum Observed Drug Concentration (Cmax)
Time frame: Parts A and C Periods 1 and 2; Part B Periods 1, 2, 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 96, 120,144,168 and 192 hours postdose
Maximum observed drug concentration.

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
Part A: Abemaciclib (R,T150 )	7	7
Part A: Abemaciclib (T150,R)	7	7
Part B: Abemaciclib (R,T150,T50 )	14	14
Part B: Abemaciclib (T150,T50,R)	15	15
Part B: Abemaciclib (T50,R,T150)	15	14
Part B: Abemaciclib (R,T50,T150)	15	15
Part B: Abemaciclib (T150,R,T50)	15	15
Part B: Abemaciclib (T50,T150,R)	15	15
Part C: Abemaciclib (T150 Fed, T150 Fasted)	12	12
Part C: Abemaciclib (T150 Fasted, T150 Fed)	12	12

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

Time frame: Parts A and C Periods 1 and 2; Part B Periods 1, 2, 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 96, 120,144,168 and 192 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: Nanograms*hour/milliliter (ng*hr/mL)

Measure	Part A: 150 mg Abemaciclib (T150) n = 13	Part A: 3 x 50 mg Abemaciclib (R) n = 12	Part B: 150 mg Abemaciclib (T150) n = 82	Part B: 3 x 50 mg Abemaciclib (T50) n = 85	Part B: 3 x 50 mg Abemaciclib (R) n = 84	Part C: 150 mg Abemaciclib (Fed) n = 23	Part C: 150 mg Abemaciclib (Fasted) n = 24
Value	3080 (57)	2880 (56)	3110 (55)	3120 (52)	3130 (59)	4170 (49)	3590 (45)

Population analysed: All randomized participants who received at least one dose of study drug and had evaluable PK data.

Primary outcome: PK: Maximum Observed Drug Concentration (Cmax)

Measure	Part A: 150 mg Abemaciclib (T150) n = 13	Part A: 3 x 50 mg Abemaciclib (R) n = 12	Part B:150 mg Abemaciclib (T150) n = 82	Part B: 3 x 50 mg Abemaciclib (T50) n = 85	Part B: 3 x 50 mg Abemaciclib (R) n = 84	Part C:150 mg Abemaciclib (Fed) n = 23	Part C:150 mg Abemaciclib (Fasted) n = 24
Value	104 (52)	101 (56)	95.2 (48)	97.7 (50)	95.8 (51)	130 (44)	99.6 (36)

Population analysed: All randomized participants who received at least one dose of study drug and had evaluable PK data.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A: 3 x 50 mg (R)	0 of 14 (0%)	7 of 14 (50%)	Not reported
Part A: 1 x 150 mg (T150)	0 of 14 (0%)	6 of 14 (42.9%)	Not reported
Part B: 3 x 50 mg (R)	0 of 88 (0%)	21 of 88 (23.9%)	Not reported
Part B 1 x 150 mg (T150)	0 of 87 (0%)	17 of 87 (19.5%)	Not reported
Part B 3 x 50 mg (T50)	0 of 88 (0%)	22 of 88 (25%)	Not reported
Part C: (T150 Fed, T150 Fasted)	0 of 24 (0%)	3 of 24 (12.5%)	Not reported
Part C: (T150 Fasted, T150 Fed)	0 of 24 (0%)	1 of 24 (4.2%)	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 Capsules (Reference Formulation) and Abemaciclib Tablet (Test Formulation) 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 5 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 (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) (time frame: Parts A and C Periods 1 and 2; Part B Periods 1, 2, 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 96, 120,144,168 and 192 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 NCT02672423.

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.