NCT01958489

Brief Summary

The main purpose of this study is to look at the effect of evacetrapib on pravastatin levels in the blood when both drugs are taken at the same time. The study will also assess how well the body handles evacetrapib and pravastatin when given at the same time. This study has two periods in fixed order. Each participant will enroll in both periods. This study will last approximately 25 days, not including screening.

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 2013

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

October 1, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 9, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

October 9, 2018

Completed
Last Updated

October 9, 2018

Status Verified

February 1, 2018

Enrollment Period

3 months

First QC Date

October 7, 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 Pravastatin

    Day 1 and Day 11: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours postdose

  • PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Pravastatin

    Day 1 and Day 11: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours postdose

  • PK: Time of Maximum Observed Concentration (Tmax) of Pravastatin

    Day 1 and Day 11: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours postdose

Study Arms (2)

Pravastatin

EXPERIMENTAL

Single 40 milligram (mg) oral dose of pravastatin administered on Day 1.

Drug: Pravastatin

Evacetrapib + Pravastatin

EXPERIMENTAL

Oral doses of 130 mg evacetrapib administered once daily on Days 2 through 11, with a single oral dose of 40 mg pravastatin coadministered on Day 11.

Drug: EvacetrapibDrug: Pravastatin

Interventions

EvacetrapibDRUG

Administered orally

Also known as: LY2484595
Evacetrapib + Pravastatin
PravastatinDRUG

Administered orally

Evacetrapib + PravastatinPravastatin

Eligibility Criteria

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

You may qualify if:

  • Overtly healthy participants, as determined by medical history and physical examination
  • Have a body mass index of 18 to 32 kilograms per square meter (kg/m²)
  • Japanese participants must be first generation Japanese

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.

Leeds, West Yorkshire, LS2 9LH, United Kingdom

Location

MeSH Terms

Interventions

evacetrapibPravastatin

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic 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

Study Record Dates

First Submitted

October 7, 2013

First Posted

October 9, 2013

Study Start

October 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

October 9, 2018

Results First Posted

October 9, 2018

Record last verified: 2018-02

Locations

GB(1)