HealthyPhase 1NCT02677844

A Study of Abemaciclib in Healthy Participants

A Phase 1 study testing Abemaciclib and Loperamide 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

The purposes of this study are to determine: The effect of single increasing doses of the study drug, abemaciclib, on healthy participants. The relationship between the amount of abemaciclib and the electrical tracing of the heart rhythm when abemaciclib is given. Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Abemaciclib and Loperamide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 35 participants
Where: 2 sitesUnited States
Study dates: Feb 2016to Jul 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 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Overtly healthy males or females, as determined by medical history and physical examination
Male participants will be sterile
Female participants must not be of childbearing potential

Who cannot join

Have known allergies to abemaciclib, related compounds, or any components of the formulation
Have an abnormality in the 12-lead electrocardiogram (ECG) including a Fridericia's corrected QT interval (QTcF) greater than 450 milliseconds (ms) (males) or greater than 470 ms (females)
Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
Have a gastrointestinal disorder causing clinically significant symptoms such as nausea, vomiting, and diarrhea, or malabsorption syndromes, or constipation
Additional Exclusion Criterion for Participants Enrolled in Cohort 2:
Have a known hypersensitivity to loperamide hydrochloride or to any of the excipients

Trial locations and contacts

2 sites in 1 country.

United States2 sites

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

Other trials in United States

About this study

Official title: A Randomized, Single-Blind, Placebo-Controlled, Single Ascending Dose Study to Determine the Exposure-Response Relationship Between Abemaciclib and QT Interval in Healthy Subjects

The purposes of this study are to determine:

The effect of single increasing doses of the study drug, abemaciclib, on healthy participants.
The relationship between the amount of abemaciclib and the electrical tracing of the heart rhythm when abemaciclib is given.
How much abemaciclib is found in the bloodstream and how long the body takes to get rid of it.

Information about any side effects that occur will be collected. The study will enroll two groups (cohorts) of participants. Each group will complete 4 study periods. This study is expected to last about 3 months. Screening may occur up to 28 days prior to enrollment. All participants will undergo a follow-up assessment approximately 21 days after administration of their final dose of study drug.

Conditions: Healthy
Being tested: Abemaciclib, Placebo, Loperamide

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
PlaceboDrug
Administered orally
LoperamideDrug
Administered orally

Study groups in NCT02677844
Study group	Role	What they receive
Abemaciclib	Experimental	200 - 600 mg single increasing oral dose of abemaciclib on Day 1 of up to 3 study periods. Receives: Drug: Abemaciclib
Placebo	Placebo comparator	Single oral dose of placebo on Day 1 of 1 study period. Receives: Drug: Placebo
Loperamide	Active comparator	Cohort 2, only. 8 mg Loperamide given orally once in 1 of 4 study periods. Receives: Drug: Loperamide
Loperamide + Abemaciclib	Experimental	Cohort 2, only. 8 mg Loperamide co-administered with abemaciclib given orally once in up to 1 of 4 study periods. Receives: Drug: Abemaciclib; Drug: Loperamide
Loperamide + Placebo	Active comparator	Cohort 2, only. 8 mg Loperamide co-administered with placebo given orally once in up to 1 of 4 study periods. Receives: Drug: Placebo; Drug: Loperamide

What is being measured

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

Mean Time Matched Placebo-Adjusted Changes From Baseline For Fridericia's Corrected QT Interval (ΔΔQTcF)
QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data. ECG monitoring was conducted using a 12-lead digital Holter recorder from approximately 2 hours predose through 24 hours postdose on Day 1 of each period using 12-lead digital Holter recorder.
Fridericia-corrected QT interval (QTcF): QTcF = QT/RR1/3, where RR is the interval between two R waves.
Measured: Day 1: 2hr,4hr,6hr,8hr,10hr,12hr,14hr,24hr Post Dose

Secondary outcomes (4)

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Abemaciclib
Blood samples were collected from participants in Cohort 1(all periods) and Cohort 2 (Periods 5, 6, and 7) to determine the plasma concentrations of Abemaciclib.
Measured: Day 1: 2, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, and 120 hours Post Dose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Last Time Point With Measurable Concentration AUC(0-tlast) of Abemaciclib
Blood samples were collected from participants in Cohort 1(all periods) and Cohort 2 (Periods 5, 6, and 7) to determine the plasma concentrations of Abemaciclib 0-tlast.
Measured: Day 1: 2, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, and 120 hours Post Dose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Last Time Point With Measurable Concentration [AUC(0-tlast)] of Loperamide
Blood samples were collected from participants in Cohort 2 Period 4 (DDI) to determine plasma concentrations of Loperamide.
Measured: Day -3: Predose, 1, 2, 4, 6, 8, 12, 14, 24, and 48 hours postdose;Day 1 predose, (-0.25 hours), and Day1: 1, 2, 4, 6, 8, 10, 12, 14, 24, 48, and 72 hours Post Dose
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Loperamide
Blood samples were collected from participants in Cohort 2 Period 4 (DDI) to determine plasma concentrations of Loperamide.
Measured: Day -3: Predose,1, 2, 4, 6, 8, 12, 14, 24, and 48 hours postdose;Day 1 predose, (-0.25 hours), and Day1: 1, 2, 4, 6, 8, 10, 12, 14, 24, 48, and 72 hours Post Dose

Timeline

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

Feb 2016Jul 2016

First posted9 Feb 2016 (estimated)
Study startFeb 2016
Primary completionJul 2016
Study completionJul 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: Single blind
Who is masked: Participant
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02677844
Sponsor's protocol ID: 16080
Other IDs: I3Y-MC-JPCA
Status last verified: Dec 2018
First submitted: 5 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?

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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 Randomized, Single-Blind, Placebo-Controlled, Single Ascending Dose Study to Determine the Exposure-Response Relationship Between Abemaciclib and QT Interval in Healthy Subjects
ClinicalTrials.gov ID: NCT02677844
Acronym / sponsor ID: 16080
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Feb 2016
Primary completion: Jul 2016 (actual)
Study completion: Jul 2016 (actual)
First posted: 9 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.

The purposes of this study are to determine:

The effect of single increasing doses of the study drug, abemaciclib, on healthy participants.
The relationship between the amount of abemaciclib and the electrical tracing of the heart rhythm when abemaciclib is given.
How much abemaciclib is found in the bloodstream and how long the body takes to get rid of it.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 5

Arm	Type	Receives
Abemaciclib	Experimental	Drug: Abemaciclib200 - 600 mg single increasing oral dose of abemaciclib on Day 1 of up to 3 study periods.
Placebo	Placebo comparator	Drug: PlaceboSingle oral dose of placebo on Day 1 of 1 study period.
Loperamide	Active comparator	Drug: LoperamideCohort 2, only. 8 mg Loperamide given orally once in 1 of 4 study periods.
Loperamide + Abemaciclib	Experimental	Drug: Abemaciclib, Drug: LoperamideCohort 2, only. 8 mg Loperamide co-administered with abemaciclib given orally once in up to 1 of 4 study periods.
Loperamide + Placebo	Active comparator	Drug: Placebo, Drug: LoperamideCohort 2, only. 8 mg Loperamide co-administered with placebo given orally once in up to 1 of 4 study periods.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Overtly healthy males or females, as determined by medical history and physical examination

Key exclusion criteria (6 listed)

Have known allergies to abemaciclib, related compounds, or any components of the formulation
Have an abnormality in the 12-lead electrocardiogram (ECG) including a Fridericia's corrected QT interval (QTcF) greater than 450 milliseconds (ms) (males) or greater than 470 ms (females)
Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
Have a gastrointestinal disorder causing clinically significant symptoms such as nausea, vomiting, and diarrhea, or malabsorption syndromes, or constipation
Have a known hypersensitivity to loperamide hydrochloride or to any of the excipients

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, Loperamide + Abemaciclib
PlaceboAdministered orally	Drug	Loperamide + Placebo, Placebo
LoperamideAdministered orally	Drug	Loperamide, Loperamide + Abemaciclib, Loperamide + Placebo

Primary outcome

Mean Time Matched Placebo-Adjusted Changes From Baseline For Fridericia's Corrected QT Interval (ΔΔQTcF)
Time frame: Day 1: 2hr,4hr,6hr,8hr,10hr,12hr,14hr,24hr Post Dose
QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data. ECG monitoring was conducted using a 12-lead digital Holter recorder from approximately 2 hours predose through 24 hours postdose on Day 1 of each period using 12-lead digital Holter recorder. Fridericia-corrected QT interval (QTcF): QTcF = QT/RR1/3, where RR is the interval between two R waves.

4 secondary outcomes

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Abemaciclib
Time frame: Day 1: 2, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, and 120 hours Post Dose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Last Time Point With Measurable Concentration AUC(0-tlast) of Abemaciclib
Time frame: Day 1: 2, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, and 120 hours Post Dose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Last Time Point With Measurable Concentration [AUC(0-tlast)] of Loperamide
Time frame: Day -3: Predose, 1, 2, 4, 6, 8, 12, 14, 24, and 48 hours postdose;Day 1 predose, (-0.25 hours), and Day1: 1, 2, 4, 6, 8, 10, 12, 14, 24, 48, and 72 hours Post Dose
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Loperamide
Time frame: Day -3: Predose,1, 2, 4, 6, 8, 12, 14, 24, and 48 hours postdose;Day 1 predose, (-0.25 hours), and Day1: 1, 2, 4, 6, 8, 10, 12, 14, 24, 48, and 72 hours Post Dose

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
Cohort 1 Sequence 1	5	5
Cohort 1 Sequence 2	5	5
Cohort 1 Sequence 3	5	5
Cohort 1 Sequence 4	5	5
Cohort 2 Sequence 1	0	0
Cohort 2 Sequence 2	0	0
Cohort 2 Sequence 3	0	0

Primary outcome: Mean Time Matched Placebo-Adjusted Changes From Baseline For Fridericia's Corrected QT Interval (ΔΔQTcF)

Time frame: Day 1: 2hr,4hr,6hr,8hr,10hr,12hr,14hr,24hr Post Dose. Mean (90% Confidence Interval). Unit: Millisecond (msec)

Measure	200 mg Abemaciclib n = 19	300 mg Abemaciclib n = 19	400 mg Abemaciclib n = 33	600 mg Abemaciclib n = 15
2hr	1.4 (-0.4 to 4.8)	3.3 (-2.1 to 4.3)	0.2 (-3.7 to 1.3)	-2.1 (-7.3 to 0.6)
4hr	-2.0 (-5.1 to 1.6)	0.8 (-4.5 to 0.8)	-0.7 (-4.9 to 0.6)	-4.2 (-9.9 to 0.9)
6hr	0.6 (-1.5 to 5.2)	-0.2 (-5.8 to 1.2)	-1.8 (-5.9 to -0.1)	-3.7 (-10.3 to -0.8)
8hr	2.8 (0.7 to 6.4)	2.7 (-3.1 to 4.0)	2.2 (-1.8 to 3.5)	2.8 (-3.9 to 5.8)
10hr	2.1 (0.6 to 5.1)	1.3 (-3.7 to 1.7)	1.5 (-2.4 to 2.1)	5.9 (-2.8 to 11)
12hr	-0.3 (-4.7 to 5.6)	-0.7 (-6.6 to 0.8)	-0.5 (-4.4 to 0.1)	4.4 (-0.9 to 7.2)
14hr	3.9 (1.4 to 7.9)	3.3 (-2.1 to 4.1)	1.0 (-3.9 to 2.6)	2.3 (-4.4 to 5.4)
24hr	1.4 (-1.2 to 5.5)	4.2 (-0.7 to 4.8)	-0.4 (-4.7 to 1.3)	0.9 (-7.1 to 4.6)

Population analysed: All randomized participants who received at least one dose of study drug and had baseline and post baseline QTcF values.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 117 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 34 (0%)	9 of 34 (26.5%)	Not reported
200 mg Abemaciclib	0 of 20 (0%)	4 of 20 (20%)	Not reported
300 mg Abemaciclib	0 of 20 (0%)	5 of 20 (25%)	Not reported
400 mg Abemaciclib	0 of 35 (0%)	17 of 35 (48.6%)	Not reported
600 mg Abemaciclib	0 of 15 (0%)	12 of 15 (80%)	Not reported
8 mg Loperamide	0 of 15 (0%)	5 of 15 (33.3%)	Not reported
8 mg Loperamide + Placebo	0 of 7 (0%)	3 of 7 (42.9%)	Not reported
8 mg Loperamide + 400 mg Abemaciclib	0 of 8 (0%)	3 of 8 (37.5%)	Not reported

Limitations and caveats (from the sponsor): At the 600-mg dose level, the protocol-specified dose escalation stopping criteria had been met so no participants received the 900-mg dose in this study.

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 and Loperamide 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 3 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 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. Some participants in this study may receive a placebo. 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?

Mean Time Matched Placebo-Adjusted Changes From Baseline For Fridericia's Corrected QT Interval (ΔΔQTcF) (time frame: Day 1: 2hr,4hr,6hr,8hr,10hr,12hr,14hr,24hr Post Dose). 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 NCT02677844.

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.