A Phase 1 interventional study of LY2835219 and Rifampin in Healthy Volunteers, sponsored by Eli Lilly and Company. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-07.
Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science
The aim of this two-period study is to compare how much of the study drug gets into the blood stream when it is given as a single oral dose and when it is given as a single oral dose in combination with rifampin (a Food and Drug Administration [FDA] approved antibiotic that is used to treat tuberculosis, a bacterial infection that mainly affects the lungs, and other infections). Each participant will complete both study periods.
The study will last about 34 days. Screening is required within 28 days before study drug is given.
Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single oral dose of LY2835219
Drug: LY2835219
Single oral dose of LY2835219 with rifampin orally, once daily for 14 days
Drug: LY2835219 · Drug: Rifampin
Administered orally
Also known as: abemaciclib
Administered orally
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2835219
Time frame: Period 1: Day 1- Predose,1, 2, 4, 6, 8, 10 hours, Days 2-9: 24, 48, 72, 96, 120, 144, 168, and 192 hours; Period 2: Day 7- Predose,1, 2, 4, 6, 8, 10 hours, Days 8-15: 24, 48, 72, 96, 120, 144, 168, 192 hours
PK: Area Under the Concentration Time Curve AUC(0-∞) of LY2835219
Time frame: Period 1: Day 1- Predose,1, 2, 4, 6, 8, 10 hours, Days 2-9: 24, 48, 72, 96, 120, 144, 168, and 192 hours; Period 2: Day 7- Predose,1, 2, 4, 6, 8, 10 hours, Days 8-15: 24, 48, 72, 96, 120, 144, 168, 192 hours
| Milestone | LY2835219 Then LY2835219 + Rifampin |
|---|---|
| Started | 24 |
| Received at least 1 dose of ly2835219 | 24 |
| Completed | 23 |
| Not completed | 1 |
| Withdrew: Adverse event | 1 |
| Milestone | LY2835219 Then LY2835219 + Rifampin |
|---|---|
| Started | 23 |
| Received at least 1 dose of rifampin | 23 |
| Completed | 23 |
| Not completed | 0 |
| Milestone | LY2835219 Then LY2835219 + Rifampin |
|---|---|
| Started | 23 |
| Received ly2835219 + rifampin | 23 |
| Completed | 22 |
| Not completed | 1 |
| Withdrew: Adverse event | 1 |
| nanogram per milliliter (ng/ml) | 200 mg LY2835219 | 200 mg LY2835219 + 600 mg Rifampin |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2835219 | 134 ± 45 | 10.5 ± 58 |
| nanogram x hour per mL (ng x h/mL) | 200 mg LY2835219 | 200 mg LY2835219 + 600 mg Rifampin |
|---|---|---|
| PK: Area Under the Concentration Time Curve AUC(0-∞) of LY2835219 | 4570 ± 53 | 229 ± 48 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LY2835219 | — | 0/24 (0%) | 8/24 (33.3%) |
| Rifampin | — | 0/23 (0%) | 2/23 (8.7%) |
| LY2835219 + Rifampin | — | 1/23 (4.3%) | 4/23 (17.4%) |
| Event | LY2835219 | Rifampin | LY2835219 + Rifampin |
|---|---|---|---|
| SyncopeNervous system disorders | 0/24 | 0/23 | 1/23 |
| Event | LY2835219 | Rifampin | LY2835219 + Rifampin |
|---|---|---|---|
| NauseaGastrointestinal disorders | 1/24 | 1/23 | 3/23 |
| Upper respiratory tract infectionInfections and infestations | 3/24 | 1/23 | 0/23 |
| HeadacheNervous system disorders | 1/24 | 0/23 | 2/23 |
| DiarrhoeaGastrointestinal disorders | 2/24 | 1/23 | 0/23 |
| CoughRespiratory, thoracic and mediastinal disorders | 2/24 | 0/23 | 0/23 |
| Age, Continuous(years) | LY2835219 Alone, Then Rifampin, Then LY2835219 + Rifampin |
|---|---|
| Mean | 58.8 ± 7.4 |
| Sex: Female, Male(Participants) | LY2835219 Alone, Then Rifampin, Then LY2835219 + Rifampin |
|---|---|
| Female | 21 |
| Male | 3 |
| Race (NIH/OMB)(Participants) | LY2835219 Alone, Then Rifampin, Then LY2835219 + Rifampin |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 6 |
| White | 15 |
| More than one race | 3 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | LY2835219 Alone, Then Rifampin, Then LY2835219 + Rifampin |
|---|---|
| United States | 24 |
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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