A Study of Abemaciclib in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: Loperamide; Drug: Abemaciclib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02677844

I3Y-MC-JPCA (Other Identifier)

16080

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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35 participants in 5 patient groups, including a placebo group

Abemaciclib

Experimental group

Description:

200 - 600 mg single increasing oral dose of abemaciclib on Day 1 of up to 3 study periods.

Treatment:

Drug: Abemaciclib

Placebo

Placebo Comparator group

Description:

Single oral dose of placebo on Day 1 of 1 study period.

Treatment:

Drug: Placebo

Loperamide

Active Comparator group

Description:

Cohort 2, only. 8 mg Loperamide given orally once in 1 of 4 study periods.

Treatment:

Drug: Loperamide

Loperamide + Abemaciclib

Experimental group

Description:

Cohort 2, only. 8 mg Loperamide co-administered with abemaciclib given orally once in up to 1 of 4 study periods.

Treatment:

Drug: Abemaciclib

Drug: Loperamide

Loperamide + Placebo

Active Comparator group

Description:

Cohort 2, only. 8 mg Loperamide co-administered with placebo given orally once in up to 1 of 4 study periods.

Treatment:

Drug: Placebo

Drug: Loperamide