A Study of Different Particle Sizes of Evacetrapib in Healthy Participants

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02497391
• Collaborator: (none)
• Enrollment: 95
• Location: 1
• Arms: 3
• Duration (Months): 4
• Patients Per Site Per Month: 23.5

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if there is any difference in the way the body handles 3 types of evacetrapib tablets with different particle sizes. Information about any side effects will also be collected. This study will consist of 3 study periods. Participants will be dosed 3 times during the entire study. Each study period will consist of an inpatient stay for 3 days - the day before dosing (Day -1), dosing day (Day 1) and the day after dosing (Day 2). Then participants will be asked to return to the clinical research unit (CRU) daily for outpatient appointments up to Day 8. The overall length of this study is about 7 weeks from first dose to end of study. Screening will take place within 28 days prior to the first dose of evacetrapib and follow-up will take place 21 days after the last dose of evacetrapib.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 95 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 Particle Sizes
• Study Start Date: Jul 1, 2015
• Actual Primary Completion Date: Nov 1, 2015
• Actual Study Completion Date: Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Evacetrapib Reference (R) Single oral dose of 130 mg evacetrapib tablet given one time during one study period.	Drug: Evacetrapib; administered orally; Other Names: LY2484595
Experimental: Evacetrapib Test 1 (T1) Single oral dose of 130 mg evacetrapib tablet given one time during one study period.	Drug: Evacetrapib; administered orally; Other Names: LY2484595
Experimental: Evacetrapib Test 2 (T2) Single oral dose of 130 mg evacetrapib tablet given one time during one study period.	Drug: Evacetrapib; administered orally; Other Names: LY2484595

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Evacetrapib [Predose on Day 1,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]

2. PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib [Predose on Day 1,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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Overtly healthy participants of non-child bearing potential

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

• Must be willing to make oneself available for the whole study and be willing to follow study procedures

Exclusion Criteria:

• Have known allergies to evacetrapib, compounds or components related to this drug, or have a history of significant allergic reactions of another origin.

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.	Singapore		Singapore	117597

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: NCT02497391
• Other Study ID Numbers: 14629; I1V-MC-EIBA
• First Posted: Jul 14, 2015
• Last Update Posted: Dec 3, 2018
• Last Verified: Nov 1, 2018

• Additional relevant MeSH terms: Evacetrapib

Study Results

Participant Flow

Pre-assignment Detail	Participants were randomized to 1 of 6 treatment sequences in a crossover design with 3 treatments; reference, test 1 and test 2. There was a washout period of ≥14 days between each dose. Participants were dosed 3 times during the entire study in periods 1, 2 and 3.

Arm/Group Title	Sequence 1 (R/T1/T2)	Sequence 2 (T1/T2/R)	Sequence 3 (T2/R/T1)	Sequence 4 (T2/T1/R)	Sequence 5 (R/T2/T1)	Sequence 6 (T1/R/T2)
Arm/Group Description	Single oral dose of evacetrapib 130 mg tablet given one time during one study period as a evacetrapib reference (R1), evacetrapib test 1 (T1) or evacetrapib test 2 (T2) formulation. All participants received one tablet in Period 1: R Period 2: T1 Period 3: T2	Single oral dose of evacetrapib 130 mg tablet given one time during one study period as a evacetrapib reference (R1), evacetrapib test 1(T1) or evacetrapib test 2 (T2) formulation. All participants received one tablet in Period 1: T1 Period 2: T2 Period 3: R	Single oral dose of evacetrapib 130 mg tablet given one time during one study period as a evacetrapib reference (R1), evacetrapib test 1 (T1) or evacetrapib test 2 (T2) formulation. All participants received one tablet in Period 1: T2 Period 2: R Period 3: T1	Single oral dose of evacetrapib 130 mg tablet given one time during one study period as a evacetrapib reference (R1), evacetrapib test 1 (T1) or evacetrapib test 2 (T2) formulation. All participants received one tablet in Period 1: T2 Period 2: T1 Period 3: R	Single oral dose of evacetrapib 130 mg tablet given one time during one study period as a evacetrapib reference (R1), evacetrapib test 1 (T1) or evacetrapib test 2 (T2) formulation. All participants received one tablet in Period 1: R Period 2: T2 Period 3: T1	Single oral dose of evacetrapib 130 mg tablet given one time during one study period as a evacetrapib reference (R1), evacetrapib test 1 (T1) or evacetrapib test 2 (T2) formulation. All participants received one tablet in Period 1: T1 Period 2: R Period 3: T2
Period Title: Period 1 (14 Days)
STARTED	16	15	16	16	16	16
Received at Least 1 Dose of Study Drug	16	15	16	16	16	16
COMPLETED	16	15	16	16	16	16
NOT COMPLETED	0	0	0	0	0	0
Period Title: Period 1 (14 Days)
STARTED	16	15	16	16	16	16
COMPLETED	12	14	13	13	14	13
NOT COMPLETED	4	1	3	3	2	3
Period Title: Period 1 (14 Days)
STARTED	12	14	13	13	14	13
COMPLETED	12	13	12	13	13	13
NOT COMPLETED	0	1	1	0	1	0

Baseline Characteristics

Arm/Group Title	Overall Participants
Arm/Group Description	Participants received a single dose of 130 mg evacetrapib tablet (a total of 3 doses of evacetrapib) given one time during each study period.
Overall Participants	95
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40.1 (10.9)
Sex: Female, Male (Count of Participants)
Female	6 6.3%
Male	89 93.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	95 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	92 96.8%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	3 3.2%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
Singapore	95 100%

Outcome Measures

1. Primary Outcome

Title	Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Evacetrapib
Time Frame	Predose on Day 1,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

Outcome Measure Data

Analysis Population Description

All participants who received at least 1 dose of study drug and had evaluable PK data.

Arm/Group Title	Evacetrapib Reference (R)	Evacetrapib Test 1 (T1)	Evacetrapib Test 2 (T2)
Arm/Group Description	Single oral dose of evacetrapib 130 mg tablet given one time during one study period.	Single oral dose of evacetrapib 130 mg tablet given one time during one study period.	Single oral dose of evacetrapib 130 mg tablet given one time during one study period.
Measure Participants	84	81	85
Geometric Mean (Geometric Coefficient of Variation) [nangram/milliliter (ng/mL)]	983 (78)	1170 (56)	1120 (66)

2. Primary Outcome

Title	PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib
Time Frame	Predose on Day 1,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

Outcome Measure Data

Analysis Population Description

All participants who received at least 1 dose of study drug and had evaluable PK data.

Arm/Group Title	Evacetrapib Reference (R)	Evacetrapib Test 1 (T1)	Evacetrapib Test 2 (T2)
Arm/Group Description	Single oral dose of evacetrapib 130 mg tablet given one time during one study period.	Single oral dose of evacetrapib 130 mg tablet given one time during one study period.	Single oral dose of evacetrapib 130 mg tablet given one time during one study period.
Measure Participants	84	81	85
Geometric Mean (Geometric Coefficient of Variation) [nanogram·hour/milliter (ng·h/mL)]	14700 (53)	16100 (45)	15500 (49)

Adverse Events

Arm/Group Title	Evacetrapib Reference (R)		Evacetrapib Test 1 (T1)		Evacetrapib Test 2 (T2)
Arm/Group Description	Single oral dose of evacetrapib 130 mg tablet given one time during one study period.		Single oral dose of evacetrapib 130 mg tablet given one time during one study period.		Single oral dose of evacetrapib 130 mg tablet given one time during one study period.
All Cause Mortality
	Evacetrapib Reference (R)		Evacetrapib Test 1 (T1)		Evacetrapib Test 2 (T2)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Evacetrapib Reference (R)		Evacetrapib Test 1 (T1)		Evacetrapib Test 2 (T2)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/84 (0%)		0/81 (0%)		0/85 (0%)
Other (Not Including Serious) Adverse Events
	Evacetrapib Reference (R)		Evacetrapib Test 1 (T1)		Evacetrapib Test 2 (T2)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	33/84 (39.3%)		22/81 (27.2%)		23/85 (27.1%)
General disorders
Catheter site related reaction	13/84 (15.5%)	13	9/81 (11.1%)	9	2/85 (2.4%)	2
Vessel puncture site bruise	16/84 (19%)	17	12/81 (14.8%)	13	20/85 (23.5%)	21
Nervous system disorders
Headache	6/84 (7.1%)	6	5/81 (6.2%)	5	2/85 (2.4%)	2

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.