A Study to Evaluate the Effect of Increased Stomach pH on Evacetrapib in Healthy Participants

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02365558
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Arms: 2
• Duration (Months): 3
• Patients Per Site Per Month: 11.5

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effect of increased stomach pH on how much evacetrapib is found in the blood stream and how long the body takes to get rid of it when given to healthy participants. Information about any side effects that may occur will also be collected.

There are two parts to the study. Participation in both parts will be required.

The study will last approximately 30 days, not including screening.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Evaluation of the Impact of Increased Gastric pH Following Omeprazole Administration on the Pharmacokinetics of Evacetrapib in Healthy Subjects
• Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Evacetrapib Single oral dose of evacetrapib administered alone on Day 1 of Period 1.	Drug: Evacetrapib; Administered orally; Other Names: LY2484595
Experimental: Omeprazole + Evacetrapib In Period 2, participants will receive 40 mg oral dose of Omeprazole once daily (QD) on Days 8 through 20. Evacetrapib will be co-administered once, orally on Day 14.	Drug: Evacetrapib; Administered orally; Other Names: LY2484595 ; Drug: Omeprazole; Administered orally

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Evacetrapib [Day 1 and Day 14 at 0, 1, 2, 3, 4, 6, 8,12, 24, 36, 48, 72, 96, 120, 144 and 168 Hours Postdose]

2. Pharmacokinetics (PK): Time of Maximum Observed Concentration (Tmax) of Evacetrapib [Day 1 and Day 14 at 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 and 168 Hours Postdose]

3. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) [Day 1 and Day 14 at 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 and 168 Hours Postdose]

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Overtly healthy participants, as determined by medical history and physical examination

• Females must be of non-child-bearing potential

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Covance Madison	Madison	Wisconsin	United States	53704

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: NCT02365558
• Other Study ID Numbers: 15373; I1V-MC-EIBO
• First Posted: Feb 19, 2015
• Last Update Posted: Oct 3, 2018
• Last Verified: Feb 1, 2018

• Additional relevant MeSH terms: Omeprazole; Evacetrapib

Study Results

Participant Flow

Arm/Group Title	Evacetrapib	Evacetrapib + Omeprazole
Arm/Group Description	Evacetrapib 130 milligram (mg) administered as a single oral dose on Day 1.	Omeprazole 40 mg administered once daily (QD) orally on Day 8 through 20. Evacetrapib 130mg coadministered as a single oral dose on Day 14.
Period Title: Period 1 (Day 1 Through Day 7)
STARTED	34	0
Received at Least One Dose of Study Drug	34	0
COMPLETED	33	0
NOT COMPLETED	1	0
Period Title: Period 1 (Day 1 Through Day 7)
STARTED	0	33
COMPLETED	0	32
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	Single oral dose of 130 mg evacetrapib on Day 1 and oral doses of 40 mg omeprazole QD on Days 8 through 20, with a single oral dose of 130 mg evacetrapib coadministered on Day 14
Overall Participants	34
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	40.9 (10.6)
Sex: Female, Male (Count of Participants)
Female	4 11.8%
Male	30 88.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 5.9%
Not Hispanic or Latino	32 94.1%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 2.9%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	14 41.2%
White	19 55.9%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	34 100%

Outcome Measures

1. Primary Outcome

Title	Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Evacetrapib
Time Frame	Day 1 and Day 14 at 0, 1, 2, 3, 4, 6, 8,12, 24, 36, 48, 72, 96, 120, 144 and 168 Hours Postdose

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug.

Arm/Group Title	Evacetrapib	Evacetrapib + Omeprazole
Arm/Group Description	Single oral dose of Evacetrapib administered on Day 1 of Period 1	In Period 2, Participants will receive 40 mg oral dose of Omeprazole QD on Days 8 through 20. Evacetrapib will be coadministered once, orally on Day 14.
Measure Participants	34	33
Geometric Mean (Geometric Coefficient of Variation) [nanograms per milliliter (ng/mL)]	748 (79)	959 (88)

2. Primary Outcome

Title	Pharmacokinetics (PK): Time of Maximum Observed Concentration (Tmax) of Evacetrapib
Time Frame	Day 1 and Day 14 at 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 and 168 Hours Postdose

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug.

Arm/Group Title	Evacetrapib	Evacetrapib + Omeprazole
Arm/Group Description	Single oral dose of evacetrapib administered alone on Day 1 of Period 1.	In Period 2, participants will receive 40 mg oral dose of Omeprazole once daily (QD) on Days 8 through 20. Evacetrapib will be co-administered once, orally on Day 14.
Measure Participants	34	33
Median (Full Range) [Hours]	3.00	3.00

3. Primary Outcome

Title	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞])
Time Frame	Day 1 and Day 14 at 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 and 168 Hours Postdose

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug.

Arm/Group Title	Evacetrapib	Evacetrapib + Omeprazole
Arm/Group Description	Single oral dose of evacetrapib administered alone on Day 1 of Period 1.	In Period 2, participants will receive 40 mg oral dose of Omeprazole once daily (QD) on Days 8 through 20. Evacetrapib will be co-administered once, orally on Day 14.
Measure Participants	34	33
Geometric Mean (Geometric Coefficient of Variation) [nanogram*hour per milliliter (ng·h/mL)]	12400 (52)	14100 (66)

Adverse Events

Arm/Group Title	Evacetrapib		Evacetrapib + Omeprazole		Evacetrapib + Omeprazole Follow-up
Arm/Group Description	Single oral dose of Evacetrapib administered alone on Day 1 of Period 1. Evacetrapib: Administered orally		In Period 2, participants will receive 40 mg oral dose of Omeprazole once daily (QD) on Days 8 through 20. Evacetrapib will be coadministered once, orally on Day 14. Evacetrapib: Administered orally Omeprazole: Administered orally		Evacetrapib + Omeprazole Follow-up will occur at least 14 days after last dose of Evacetrapib on Day 14.
All Cause Mortality
	Evacetrapib		Evacetrapib + Omeprazole		Evacetrapib + Omeprazole Follow-up
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Evacetrapib		Evacetrapib + Omeprazole		Evacetrapib + Omeprazole Follow-up
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/33 (0%)		0/33 (0%)
Other (Not Including Serious) Adverse Events
	Evacetrapib		Evacetrapib + Omeprazole		Evacetrapib + Omeprazole Follow-up
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/34 (14.7%)		2/33 (6.1%)		3/33 (9.1%)
General disorders
Vessel puncture site reaction	1/34 (2.9%)	1	0/33 (0%)	0	2/33 (6.1%)	2
Nervous system disorders
Headache	4/34 (11.8%)	5	2/33 (6.1%)	3	1/33 (3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.