A Study of Abemaciclib in Healthy Participants
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 1/6/2019 |
| Start Date: | February 2016 |
| End Date: | July 2016 |
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.
- 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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
We found this trial at
2
sites
Daytona Beach, Florida 32117
Principal Investigator: Hugh Coleman
Phone: 386-366-6400
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Evansville, Indiana 47710
Principal Investigator: Kelly Whitehurst
Phone: 812-474-5000
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