Study of Food on Evacetrapib (LY2484595) in Healthy Participants

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01810432
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 3
• Patients Per Site Per Month: 13.2

Study Details

Study Description

Brief Summary

The purpose of this study is to measure how much of the drug gets into the blood stream and how long it takes the body to get rid of it when given to healthy participants. Information about any side effects that may occur will also be collected.

The study has 2 periods. In each period, participants will take the study drug for 10 days, either with or without a meal. There is a minimum 14-day washout between each period.

This study is approximately 50 days, not including screening. Screening is required within 28 days prior to the start of the study.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Evacetrapib; Other: High-fat Meal	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Effect of Food on the Pharmacokinetics of Evacetrapib (LY2484595) in Healthy Subjects
• Study Start Date: Mar 1, 2013
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Evacetrapib (Fasted) 130 milligram (mg) oral dose of evacetrapib once daily in a fasted state for 10 days.	Drug: Evacetrapib; Administered orally; Other Names: LY2484595
Experimental: Evacetrapib (Fed) 130 mg oral dose of evacetrapib once daily following a high-fat breakfast for 10 days.	Drug: Evacetrapib; Administered orally; Other Names: LY2484595 ; Other: High-fat Meal; Administered orally, at breakfast.

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib [Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose]

2. PK: Area Under Concentration Versus Time Curve Over the 24-hour Dosing Interval (AUCτ) of Evacetrapib [Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose]

3. PK: Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib [Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose]

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• 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)

• Are able to eat a high fat breakfast and abide by the food restrictions throughout the study

Exclusion Criteria:

• Have known allergies to evacetrapib, related compounds or any components of the formulation

• 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

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

• Are participants who currently smoke cigarettes or use tobacco or nicotine substitutes

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.	Daytona Beach	Florida	United States	32117

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: NCT01810432
• Other Study ID Numbers: 14626; I1V-MC-EIAX
• First Posted: Mar 13, 2013
• Last Update Posted: Oct 12, 2018
• Last Verified: Oct 1, 2018

• Additional relevant MeSH terms: Evacetrapib

Study Results

Participant Flow

Arm/Group Title	Sequence 1 (Fast/Fed)	Sequence 2 (Fed/Fasted)
Arm/Group Description	Participants received a 130 milligram (mg) oral tablet of evacetrapib once daily (QD) for 10 days (Period 1) in a fasted state. Following a 14-day washout period participants received a 130 mg oral tablet of evacetrapib QD for 10 days (Period 2) following a high-fat breakfast.	Participants received a 130 mg oral tablet of evacetrapib QD for 10 days (Period 1) following a high-fat breakfast. Following a 14-day washout period participants received a 130 mg oral tablet of evacetrapib QD for 10 days (Period 2) in a fasted state.
Period Title: Period 1
STARTED	20	20
Received at Least 1 Dose of Study Drug	20	20
COMPLETED	20	20
NOT COMPLETED	0	0
Period Title: Period 1
STARTED	20	20
COMPLETED	19	19
NOT COMPLETED	1	1
Period Title: Period 1
STARTED	19	19
Received at Least 1 Dose of Study Drug	19	19
COMPLETED	15	17
NOT COMPLETED	4	2

Baseline Characteristics

Arm/Group Title	Evacetrapib
Arm/Group Description	Sequence 1-participants received a 130 mg oral tablet of evacetrapib QD for 10 days (Period 1) in a fasted state. Following a 14-day washout period, participants received a 130 mg oral tablet of evacetrapib QD for 10 days (Period 2) following a high-fat breakfast. Sequence 2-participants received a 130 mg oral tablet of evacetrapib QD for 10 days (Period 1) following a high-fat breakfast. Following a 14-day washout period participants received a 130 mg oral tablet of evacetrapib QD for 10 days (Period 2) in a fasted state.
Overall Participants	40
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41.5 (13.0)
Sex: Female, Male (Count of Participants)
Female	6 15%
Male	34 85%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	14 35%
Not Hispanic or Latino	26 65%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	40 100%

Outcome Measures

1. Primary Outcome

Title	Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib
Time Frame	Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

All participants with evaluable Cmax data.

Arm/Group Title	Evacetrapib (Fasted)	Evacetrapib (Fed)
Arm/Group Description	Participants received a 130 mg oral tablet of evacetrapib QD in a fasted state for 10 days.	Participants received a 130 mg oral tablet of evacetrapib QD following a high-fat breakfast for 10 days.
Measure Participants	39	37
Geometric Mean (Geometric Coefficient of Variation) [nanograms/milliliter (ng/mL)]	1140 (73)	1720 (22)

2. Primary Outcome

Title	PK: Area Under Concentration Versus Time Curve Over the 24-hour Dosing Interval (AUCτ) of Evacetrapib
Time Frame	Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

All participants with evaluable AUCτ data.

Arm/Group Title	Evacetrapib (Fasted)	Evacetrapib (Fed)
Arm/Group Description	Participants received a 130 mg oral tablet of evacetrapib QD in a fasted state for 10 days.	Participants received a 130 mg oral tablet of evacetrapib QD following a high-fat breakfast for 10 days.
Measure Participants	39	36
Geometric Mean (Geometric Coefficient of Variation) [nanograms*hour/milliliter (ng*h/mL)]	9930 (49)	14400 (19)

3. Primary Outcome

Title	PK: Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib
Time Frame	Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

All participants with evaluable tmax data.

Arm/Group Title	Evacetrapib (Fasted)	Evacetrapib (Fed)
Arm/Group Description	Participants received a 130 mg oral tablet of evacetrapib QD in a fasted state for 10 days.	Participants received a 130 mg oral tablet of evacetrapib QD following a high-fat breakfast for 10 days.
Measure Participants	39	37
Median (Full Range) [hours (h)]	3.00	3.00

Adverse Events

Adverse Event Reporting Description	The total number of participants at risk in the Fasted and Fed groups is the number of participants who started Period 1 and Period 2.
Arm/Group Title	Evacetrapib (Fasted)		Evacetrapib (Fed)
Arm/Group Description	Participants received 130-mg oral tablet fo evacetrapib QD in a fasted state for 10 days.		Participants received 130-mg oral tablet of evacetrapib QD following a high-fat breakfast for 10 days.
All Cause Mortality
	Evacetrapib (Fasted)		Evacetrapib (Fed)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Evacetrapib (Fasted)		Evacetrapib (Fed)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/39 (0%)		0/39 (0%)
Other (Not Including Serious) Adverse Events
	Evacetrapib (Fasted)		Evacetrapib (Fed)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/39 (17.9%)		4/39 (10.3%)
Gastrointestinal disorders
Abdominal pain	2/39 (5.1%)	2	1/39 (2.6%)	1
Diarrhoea	4/39 (10.3%)	4	0/39 (0%)	0
Nervous system disorders
Headache	2/39 (5.1%)	2	3/39 (7.7%)	3
Respiratory, thoracic and mediastinal disorders
Nasal congestion	2/39 (5.1%)	2	0/39 (0%)	0
Throat irritation	2/39 (5.1%)	2	0/39 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Investigators agreed to delay independently publishing or disclosing data, findings or conclusions from the study except as part of a multi-center publication. Upon study publication or if the draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to confidential information review/redaction by sponsor. The sponsor may request publication delay up to 90 days to seek patent protection.