Abemaciclib in healthy adults: comparing tablet and granule forms to see how they enter the bloodstream
Official title: A Phase 1, Open-Label, Randomized, Crossover Study to Investigate the Relative Bioavailability of Abemaciclib (LY2835219) Test and Reference Formulations and an Alternate Administration Method, in Healthy Participants.
Run by Eli Lilly and Company · NCT07818967 · Data updated 2026-11-12
This study tests different oral forms of abemaciclib in healthy volunteers to see how much and how fast the drug gets into the blood and what side effects occur.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 21 Years and up |
| Sex | All |
| Enrollment | 15 (estimated) |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 1 site (Singapore) |
| Status | Recruiting |
| Started | September 2, 2026 |
| Main results expected | November 2026 |
| Study ends | November 2026 |
| Registry record updated | September 23, 2026 |
| Trial ID | NCT07818967 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults who are healthy, have BMI 18–32 kg/m², weigh at least 45 kg, and meet contraception/sterility criteria appropriate for male or female birth assignment.
✕Probably not a fit
Participants who are not healthy or have underlying conditions that affect drug metabolism or safety may not derive direct benefit from the study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1, interventional study compares multiple formulations of abemaciclib—test tablets, a reference tablet, and test oral granules—in healthy adult participants. The goal is to measure pharmacokinetic parameters such as absorption and blood concentration after ingestion, as well as safety and tolerability. Each participant undergoes up to three 10-day stays in a clinical research unit, with an overall study duration of about 12 weeks. Safety monitoring includes medical history, physical exams, lab tests, and cardiac monitoring. The study is sponsored by Eli Lilly and conducted at the Lilly Centre for Clinical Pharmacology in Singapore.
Why it matters
Potential benefit: If successful, the findings could inform dosing form choices and improve understanding of how different abemaciclib formulations behave in humans.
How similar studies have gone: Prior work with abemaciclib has explored pharmacokinetics and safety in humans, supporting the rationale for formulation comparison in healthy volunteers.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. * Have a body mass index (BMI) within the range of 18 to 32 kilograms per square meter (kg/m²), inclusive, and have a body weight of 45 kilograms (kg) or greater. * Individuals assigned male at birth (AMAB) should be sterile, including vasectomy. * Individuals who are assigned female at birth (AFAB) and are individuals not of childbearing potential (INOCBP). * Have clinical laboratory test results within normal reference range for the population or investigative site. * Have a hemoglobin level of 12.5 grams per deciliter (g/dL) or greater for males, or 11.4 g/dL for females. * Have venous access sufficient to allow for blood sampling. Exclusion Criteria: * Have known allergies to abemaciclib, related compounds, or any components of the formulations, or have a history of significant atopy. * Have a 12-lead electrocardiogram (ECG) abnormality at screening that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG data analysis. * Have abnormal blood pressure as determined by the investigator. * Have a gastrointestinal disorder causing clinically significant symptoms such as nausea, vomiting, and diarrhea, or malabsorption syndromes. * Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders that could significantly alter the absorption, metabolism, or elimination of drugs, of constituting a risk when taking the study medication, or of interfering with the interpretation of study data. * Have known or ongoing psychiatric disorders. * Have used or intend to use over the counter or prescription medication, or herbal supplements, within 14 days prior to the first dose. The use of topical medicine, provided there is no evidence of chronic dosing with risk of systemic exposure, and occasional acetaminophen is acceptable. * Use or intend to use any medications or products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 14 days prior to Study Day 1, unless deemed acceptable by the investigator or designee. * Use or intend to use medications that are moderate or strong inhibitors or inducers of Cytochrome P450 3A4 (CYP3A4), including cannabidiol- or cannabis-containing products, within 14 days prior to Study Day 1 until completion of the follow-up phone call. * Regularly use known drugs of abuse. * Show evidence of Human Immunodeficiency Virus (HIV) infection or positive HIV antibodies. * Have a positive Hepatitis C Virus (HCV) antibody test. Participants with a positive HCV antibody test at screening can be included only if a confirmatory HCV Ribonucleic Acid (RNA) test is negative. * Show evidence of hepatitis B or positive hepatitis B surface antigen. * Have made a blood donation of 450 milliliters (mL) or greater, or have participated in a clinical study that required a blood volume of 400 mL or more since the last study visit, within the last 3 calendar months. * Are unwilling to refrain from strenuous exercise for at least 72 hours prior to each dose and during each inpatient stay. * Have alcohol intake that exceeds recommended average weekly alcohol consumption limits per local regulation, or an amount deemed significant by the investigator, or are unwilling to stop alcohol consumption for at least 48 hours prior to each Clinical Research Unit (CRU) admission until discharge from the CRU in each treatment period. * Are unwilling to refrain from consuming caffeine- or xanthine- containing products from at least 48 hours prior to each CRU admission until discharge from the CRU in each treatment period. * Are currently, or have been, smokers or users of tobacco or nicotine replacement products within the 6 months prior to the first CRU admission, or have a positive cotinine test at screening. * Are unwilling to comply with the dietary requirements and restrictions of this study.
Where it's running
-
Lilly Centre for Clinical Pharmacology
Singapore, Singapore Recruiting
Study contacts
- Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Email: LillyTrials@Lilly.com
- Phone: 1-317-615-4559
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
EloraTZP for weight loss in adults with overweight/obesity and type 2 diabetes
This trial tests whether a coformulation of eloralintide and tirzepatide helps people with obesity or overweight and type 2 diabetes lose weight compared with tirzepatide alone.
-
Weekly tirzepatide vs placebo for pediatric obesity (6 to <12 years)
This study tests whether weekly tirzepatide can help children aged 6 to under 12 with obesity, in addition to healthy lifestyle guidance.
-
Testing LY4329090 in adults with overweight or obesity who are otherwise healthy
This study tests how LY4329090 works in adults with overweight or obesity who are otherwise healthy to see if it is tolerated and what side effects might occur.
-
Eloralintide and birth-control pill study in women with overweight or obesity
This study tests whether eloralintide affects how oral contraceptives work in women with overweight or obesity.
-
Tirzepatide for type 1 diabetes patients who are overweight or obese
This study tests whether tirzepatide can affect stomach emptying in adults with type 1 diabetes and overweight or obesity.
-
Ly5625575: safety and how the body handles the drug in healthy people and those with inflammation
This study tests LY5625575 in healthy volunteers and in people with elevated C-reactive protein to see if it is safe, well-tolerated, and how it behaves in the body.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.