HealthyPhase 1NCT02884089

A Study of the Effect of Abemaciclib on Metformin and Iohexol in Healthy Participants

A Phase 1 study testing Abemaciclib, Metformin and Iohexol in people with Healthy, 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

This study will look at how a single dose of abemaciclib will impact the body's ability to get rid of two other drugs, metformin and iohexol. In addition, this study will evaluate the effect of a single dose of abemaciclib on kidney function by measuring blood and urine markers. Side effects will also be documented. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Abemaciclib, Metformin and Iohexol
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteUnited States
Study dates: Aug 2016to Dec 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) between 18 and 32 kilograms per meter squared (kg/m²), inclusive at screening

Who cannot join

Have known allergies to abemaciclib, metformin, iodine, iohexol, 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 and/or positive antibodies of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C

Trial locations and contacts

1 site in 1 country.

United States1 site

Dallas Clinical Research Unit
Dallas, Texas, 75247

Other trials in United States

About this study

Official title: Effect of Abemaciclib on Metformin Pharmacokinetics and Iohexol Clearance

Each participant will complete four study periods. During each study period, participants will stay in the clinical research unit for nine days and eight nights.

The study will last approximately 10 weeks, not including screening. Screening is required within 28 days prior to the start of the study.

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

Conditions: Healthy
Being tested: Abemaciclib, Metformin, Iohexol, Placebo

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
MetforminDrug
Administered orally
IohexolDrug
Administered intravenously (IV)
PlaceboDrug
Administered orally

Study groups in NCT02884089
Study group	Role	What they receive
Placebo + Metformin	Placebo comparator	Single dose of placebo administered orally followed by a single dose of metformin administered orally in one of four study periods. Receives: Drug: Metformin; Drug: Placebo
Abemaciclib + Metformin	Experimental	Single dose of abemaciclib administered orally followed by a single dose of metformin administered orally in one of four study periods. Receives: Drug: Abemaciclib; Drug: Metformin
Placebo + Iohexol	Placebo comparator	Single dose of placebo administered orally followed by a single dose of iohexol administered intravenously (IV) in one of four study periods. Receives: Drug: Iohexol; Drug: Placebo
Abemaciclib + Iohexol	Experimental	Single dose of abemaciclib administered orally followed by a single dose of iohexol administered intravenously (IV) in one of four study periods. Receives: Drug: Abemaciclib; Drug: Iohexol

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 Time Zero to Infinity (AUC[0-∞]) of Metformin
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-∞]) of Metformin was evaluated.
Measured: Pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36 hours (h) post dose
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Metformin
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Metformin was evaluated.
Measured: Pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36 hours (h) post dose
Pharmacokinetics (PK): Renal Clearance (CLr) of Metformin
Pharmacokinetics (PK): Renal Clearance (CLr) of Metformin was evaluated.
Measured: Pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36 hours (h) post dose

Secondary outcomes (1)

Pharmacokinetics (PK): Renal Clearance (CLr) of Iohexol
Pharmacokinetics (PK): Renal Clearance (CLr) of Iohexol was evaluated.
Measured: Pre infusion, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6 hours post infusion

Timeline

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

Aug 2016Dec 2016

First posted30 Aug 2016 (estimated)
Study startAug 2016
Primary completionDec 2016
Study completionDec 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: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02884089
Sponsor's protocol ID: 16536
Other IDs: I3Y-MC-JPCK
Status last verified: Dec 2018
First submitted: 25 Aug 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: Effect of Abemaciclib on Metformin Pharmacokinetics and Iohexol Clearance
ClinicalTrials.gov ID: NCT02884089
Acronym / sponsor ID: 16536
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Aug 2016
Primary completion: Dec 2016 (actual)
Study completion: Dec 2016 (actual)
First posted: 30 Aug 2016 (estimated)
Results: Posted 7 Aug 2018

Clinical summary

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

Each participant will complete four study periods. During each study period, participants will stay in the clinical research unit for nine days and eight nights.

The study will last approximately 10 weeks, not including screening. Screening is required within 28 days prior to the start of the study.

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: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
Placebo + Metformin	Placebo comparator	Drug: Metformin, Drug: PlaceboSingle dose of placebo administered orally followed by a single dose of metformin administered orally in one of four study periods.
Abemaciclib + Metformin	Experimental	Drug: Abemaciclib, Drug: MetforminSingle dose of abemaciclib administered orally followed by a single dose of metformin administered orally in one of four study periods.
Placebo + Iohexol	Placebo comparator	Drug: Iohexol, Drug: PlaceboSingle dose of placebo administered orally followed by a single dose of iohexol administered intravenously (IV) in one of four study periods.
Abemaciclib + Iohexol	Experimental	Drug: Abemaciclib, Drug: IohexolSingle dose of abemaciclib administered orally followed by a single dose of iohexol administered intravenously (IV) in one of four study periods.

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) between 18 and 32 kilograms per meter squared (kg/m²), inclusive at screening

Key exclusion criteria (3 listed)

Have known allergies to abemaciclib, metformin, iodine, iohexol, 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 and/or positive antibodies 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 + Iohexol, Abemaciclib + Metformin
MetforminAdministered orally	Drug	Abemaciclib + Metformin, Placebo + Metformin
IohexolAdministered intravenously (IV)	Drug	Abemaciclib + Iohexol, Placebo + Iohexol
PlaceboAdministered orally	Drug	Placebo + Iohexol, Placebo + Metformin

Primary outcome

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Metformin
Time frame: Pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36 hours (h) post dose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-∞]) of Metformin was evaluated.
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Metformin
Time frame: Pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36 hours (h) post dose
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Metformin was evaluated.
Pharmacokinetics (PK): Renal Clearance (CLr) of Metformin
Time frame: Pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36 hours (h) post dose
Pharmacokinetics (PK): Renal Clearance (CLr) of Metformin was evaluated.

1 secondary outcome

Pharmacokinetics (PK): Renal Clearance (CLr) of Iohexol
Time frame: Pre infusion, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6 hours post infusion

Results and safety

Results posted to the registry on 7 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
Sequence 1	11	9
Sequence 2	11	9
Sequence 3	9	9
Sequence 4	9	9

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

Time frame: Pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36 hours (h) post dose. Geometric mean (Geometric Coefficient of Variation). Unit: Nanogram*Hour per Milliliter (ng*h/mL)

Measure	Placebo + 1000 mg Metformin n = 30	400 mg Abemaciclib + 1000 mg Metformin n = 28
Value	12100 (23)	16800 (30)

Population analysed: All randomized participants who received at least one dose of study Abemaciclib or placebo along with Metformin and had evaluable PK data.

Primary outcome: Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Metformin

Time frame: Pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36 hours (h) post dose. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Placebo + 1000 mg Metformin n = 30	400 mg Abemaciclib + 1000 mg Metformin n = 28
Value	1550 (23)	1940 (31)

Population analysed: All randomized participants who received at least one dose of study Abemaciclib or placebo along with Metformin and had evaluable PK data.

Primary outcome: Pharmacokinetics (PK): Renal Clearance (CLr) of Metformin

Time frame: Pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36 hours (h) post dose. Geometric mean (Geometric Coefficient of Variation). Unit: Liters per Hour (L/h)

Measure	Placebo + 1000 mg Metformin n = 30	400 mg Abemaciclib + 1000 mg Metformin n = 28
Value	21.5 (22)	11.9 (35)

Population analysed: All randomized participants who received at least one dose of study Abemaciclib or placebo along with Metformin and had evaluable PK data.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 92 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo + 1000 mg Metformin	0 of 33 (0%)	8 of 33 (24.2%)	Not reported
400 mg Abemaciclib + 1000 mg Metformin	0 of 35 (0%)	11 of 35 (31.4%)	Not reported
Placebo + 5 mL Iohexol	0 of 32 (0%)	0 of 32 (0%)	Not reported
400 mg Abemaciclib + 5 mL Iohexol	0 of 33 (0%)	6 of 33 (18.2%)	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

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 Abemaciclib, Metformin and Iohexol in people with Healthy, 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 3 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 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. 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 7 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 Time Zero to Infinity (AUC[0-∞]) of Metformin (time frame: Pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36 hours (h) post dose). 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 NCT02884089.

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.