NCT02256267

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Oct 2014

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2014

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

August 2, 2018

Completed
Last Updated

January 7, 2019

Status Verified

December 1, 2018

Enrollment Period

1 month

First QC Date

October 1, 2014

Results QC Date

October 27, 2017

Last Update Submit

December 13, 2018

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2835219

    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

    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

Study Arms (2)

LY2835219

EXPERIMENTAL

Single oral dose of LY2835219

Drug: LY2835219

LY2835219 + Rifampin

EXPERIMENTAL

Single oral dose of LY2835219 with rifampin orally, once daily for 14 days

Drug: LY2835219Drug: Rifampin

Interventions

LY2835219DRUG

Administered orally

Also known as: abemaciclib
LY2835219LY2835219 + Rifampin
RifampinDRUG

Administered orally

LY2835219 + Rifampin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Overtly healthy sterile males or surgically sterile females or postmenopausal females
  • Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m\^2)

You may not qualify if:

  • Have participated in a clinical trial involving investigational product within the last 30 days
  • Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
  • Have an abnormal blood pressure
  • Show evidence of human immunodeficiency virus (HIV), hepatitis B or hepatitis C
  • Have donated blood of more than 500 milliliters (mL) within the last month
  • Have used or intend to use over-the-counter or prescription medication including herbal medications within 7 days prior to dosing or during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Dallas, Texas, 75247, United States

Location

MeSH Terms

Interventions

abemaciclibRifampin

Intervention Hierarchy (Ancestors)

RifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLactams, MacrocyclicMacrocyclic CompoundsPolycyclic Compounds

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR
Expanded Access
Yes

Study Record Dates

First Submitted

October 1, 2014

First Posted

October 3, 2014

Study Start

October 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

January 7, 2019

Results First Posted

August 2, 2018

Record last verified: 2018-12

Locations

US(1)