NCT01908582

Brief Summary

The main purpose of this study is to determine how much evacetrapib gets into the blood stream and how long it takes the body to get rid of it when given with rifampin. The safety and tolerability of the two drugs, given together, will also be evaluated. The study will also look at blood cholesterol levels and levels of a hormone called cortisol before and after taking rifampin. Information about any side effects that may occur will also be collected. For each participant, this study will include 2 periods in fixed order. The study will last approximately 29 days.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Jul 2013

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

Study Start

First participant enrolled

July 1, 2013

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
5.1 years until next milestone

Results Posted

Study results publicly available

October 3, 2018

Completed
Last Updated

October 3, 2018

Status Verified

February 1, 2018

Enrollment Period

2 months

First QC Date

July 23, 2013

Results QC Date

February 18, 2018

Last Update Submit

February 18, 2018

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

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

    Day 1 and Day 16, predose of evacetrapib and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose

  • Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib

    Day 1 and Day 16, predose of evacetrapib and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose

  • Pharmacokinetics, Area Under the Plasma Concentration-Time Curve From Time 0 Hour (h) to Infinity (AUC0-∞) of Evacetrapib

    Day 1 and Day 16, predose of evacetrapib and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose

Study Arms (2)

Evacetrapib

EXPERIMENTAL

Period 1: 130 milligram (mg) evacetrapib administered orally, once on Day 1

Drug: Evacetrapib

Evacetrapib + Rifampin

EXPERIMENTAL

Period 2: Rifampin: 600 mg administered orally, once daily (QD) for 14 days (Days 9 to 22) Evacetrapib: 130 mg administered orally once on Day 16

Drug: EvacetrapibDrug: Rifampin

Interventions

EvacetrapibDRUG

Administered orally

Also known as: LY2484595
EvacetrapibEvacetrapib + Rifampin
RifampinDRUG

Administered orally

Evacetrapib + Rifampin

Eligibility Criteria

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

You may qualify if:

  • Overtly healthy males and females (of non child-bearing potential)
  • Have a body mass index of 18 to 32 kilograms per square meter (kg/m\^2), inclusive, at screening

You may not qualify if:

  • Have known allergies to evacetrapib, rifampin, related compounds or any components of either formulation, or history of significant allergic disease as determined by the investigator

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.

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Interventions

evacetrapibRifampin

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
GT60
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

Study Record Dates

First Submitted

July 23, 2013

First Posted

July 25, 2013

Study Start

July 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

October 3, 2018

Results First Posted

October 3, 2018

Record last verified: 2018-02

Locations

US(1)