A Study of Evacetrapib (LY2484595) in Healthy Participants

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01903434
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 4
• Patients Per Site Per Month: 14.8

Study Details

Study Description

Brief Summary

The purpose of this study is to measure and compare the amounts of the study drug evacetrapib found in the blood after taking two different formulations. The study has 3 periods. Participants will take each formulation by mouth at least once. A minimum of 14 days will pass between study drug doses. The safety and tolerability of the study drug will also be examined. Information about any side effects that may occur will also be collected. This study will last approximately 6 weeks.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Evacetrapib	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A Bioequivalence Study in Healthy Subjects Administered Evacetrapib Tablets of Varying Tablet Solid Fractions
• Study Start Date: Jul 1, 2013
• Actual Primary Completion Date: Nov 1, 2013
• Actual Study Completion Date: Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Evacetrapib -- Solid Fraction Test Single oral dose of 130 milligram (mg) evacetrapib tablet on Day 1 of up to 2 of 3 periods	Drug: Evacetrapib; Administered orally; Other Names: LY2484595
Experimental: Evacetrapib -- Solid Fraction Reference Single oral dose of 130 mg evacetrapib tablet on Day 1 of up to 2 of 3 periods	Drug: Evacetrapib; Administered orally; Other Names: LY2484595

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib (LY2484595) [Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose in each period]

   The maximum observed drug concentration (Cmax) of evacetrapib is summarized for each solid fraction control (Reference and Test).

2. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib (LY2484595) [Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose in each period]

   Evacetrapib exposure in terms of Area Under the Concentration Versus Time Curve from time 0 extrapolated to infinity (AUC[0-∞]) is summarized for each solid fraction control (Reference and Test).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Male participants who agree to use a reliable method of birth control and not donate sperm during the study and for 90 days after study completion

• Female participants who are not of child-bearing potential due to surgical sterilization confirmed by medical history or menopause

• Have a body mass index of 18 to 32 kilograms per square meter (kg/m^2)

• Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Exclusion Criteria:

• Are currently enrolled in or have completed or discontinued within the last 30 days from a clinical trial involving an investigational product

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

• Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders

• Regularly use known drugs of abuse and/or show positive findings on urinary drug screening

• Are women who are pregnant or lactating

• Have used or intend to use over-the-counter or prescription medications (including vitamins/mineral supplements, herbal medicine) 14 days prior to enrollment and during the study

• Have donated blood of more than 500 milliliters (mL) within the last month

• Have an average weekly alcohol intake that exceeds 21 units per week (for males) and 14 units per week (for females) or are unwilling to stop alcohol consumption 48 hours prior to each dose and while resident at the Clinical Research Unit (CRU)

• Currently smoke or use tobacco or nicotine products

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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.	Evansville	Indiana	United States	47710

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT01903434
• Other Study ID Numbers: 14623; I1V-MC-EIAU
• First Posted: Jul 19, 2013
• Last Update Posted: Oct 9, 2018
• Last Verified: Feb 1, 2018

• Additional relevant MeSH terms: Evacetrapib

Study Results

Participant Flow

Arm/Group Title	Reference/Test/Test	Test/Reference/Reference
Arm/Group Description	A single dose of Reference 130 mg evacetrapib on Day 1 of Period 1 and of Test 130 mg evacetrapib on Day 1 of Period 2 and Day 1 of Period 3. There was a washout period of at least 14 days between doses. Each participant received up to 3 doses.	A single dose of Test 130 mg evacetrapib on Day 1 of Period 1 and of Reference 130 mg evacetrapib on Day 1 of Period 2 and Day 1 of Period 3. There was a washout period of at least 14 days between doses. Each participant received up to 3 doses.
Period Title: Treatment Period 1
STARTED	30	30
Received at Least 1 Dose of Study Drug	30	30
COMPLETED	30	30
NOT COMPLETED	0	0
Period Title: Treatment Period 1
STARTED	30	30
COMPLETED	29	28
NOT COMPLETED	1	2
Period Title: Treatment Period 1
STARTED	29	28
Received at Least 1 Dose of Study Drug	29	28
COMPLETED	29	28
NOT COMPLETED	0	0
Period Title: Treatment Period 1
STARTED	29	28
COMPLETED	29	28
NOT COMPLETED	0	0
Period Title: Treatment Period 1
STARTED	29	28
Received at Least 1 Dose of Study Drug	29	28
COMPLETED	29	28
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	130 mg Evacetrapib
Arm/Group Description	Participants randomized to receive a single dose of 130 mg evacetrapib of either of the two different solid fraction controls on Day 1 of each of 3 treatment periods, according to their assigned treatment sequence.
Overall Participants	60
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41.6 (13.1)
Sex: Female, Male (Count of Participants)
Female	10 16.7%
Male	50 83.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 3.3%
Not Hispanic or Latino	58 96.7%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 1.7%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	19 31.7%
White	39 65%
More than one race	1 1.7%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	60 100%

Outcome Measures

1. Primary Outcome

Title	Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib (LY2484595)
Description	The maximum observed drug concentration (Cmax) of evacetrapib is summarized for each solid fraction control (Reference and Test).
Time Frame	Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose in each period

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of evacetrapib and had evaluable evacetrapib concentration data.

Arm/Group Title	Reference	Test
Arm/Group Description	Evacetrapib: 130 mg with a solid fraction of 0.86 administered on Day 1 of up to 2 of 3 treatment periods.	Evacetrapib: 130 mg with a solid fraction of 0.89 administered on Day 1 of up to 2 of 3 treatment periods.
Measure Participants	58	59
Geometric Mean (Geometric Coefficient of Variation) [nanograms per milliliter]	604 (76)	597 (102)

2. Primary Outcome

Title	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib (LY2484595)
Description	Evacetrapib exposure in terms of Area Under the Concentration Versus Time Curve from time 0 extrapolated to infinity (AUC[0-∞]) is summarized for each solid fraction control (Reference and Test).
Time Frame	Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose in each period

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of evacetrapib and had evaluable evacetrapib concentration data.

Arm/Group Title	Reference	Test
Arm/Group Description	Evacetrapib: 130 mg with a solid fraction of 0.86 administered on Day 1 of up to 2 of 3 treatment periods.	Evacetrapib: 130 mg with a solid fraction of 0.89 administered on Day 1 of up to 2 of 3 treatment periods.
Measure Participants	58	59
Geometric Mean (Geometric Coefficient of Variation) [nanograms times hours per milliliter]	10400 (56)	10300 (68)

Adverse Events

Arm/Group Title	Reference		Test
Arm/Group Description	Evacetrapib: 130 mg with a solid fraction of 0.86 administered on Day 1 of up to 2 of 3 treatment periods.		Evacetrapib: 130 mg with a solid fraction of 0.89 administered on Day 1 of up to 2 of 3 treatment periods.
All Cause Mortality
	Reference		Test
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Reference		Test
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/58 (0%)		0/59 (0%)
Other (Not Including Serious) Adverse Events
	Reference		Test
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/58 (6.9%)		1/59 (1.7%)
Nervous system disorders
Headache	4/58 (6.9%)	4	1/59 (1.7%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.