A Study of LY3006072 in Healthy Participants

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01640249
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arms: 2
• Actual Duration (Months): 4.1
• Patients Per Site Per Month: 4.4

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate how safe LY3006072 (study drug) is and whether it causes any side effects. The study will also measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of the study drug. The study drug will be given in the morning or evening with or without a meal.

This is the first time that this study drug is being given to humans. This study is for research purposes only and is not intended to treat any medical condition.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Placebo; Drug: LY3006072	Phase 1

Detailed Description

This study has two parts:

Part A - single ascending dose of LY3006072 administered to healthy participants in 3 of 4 study periods (placebo in 1 of 4 periods).

Part B - morning and evening doses of LY3006072 given to healthy participants in fed and fasted states in 2 or 3 of 3 study periods (placebo in 1 of 3 periods for some participants).

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: A Single Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY3006072 in Healthy Subjects
• Actual Study Start Date: Jul 24, 2012
• Actual Primary Completion Date: Nov 26, 2012
• Actual Study Completion Date: Nov 26, 2012

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Participants received placebo capsule orally with approximately 200 to 300 milliliter (mL) of room temperature water in the morning.	Drug: Placebo; Capsules administered orally
Experimental: LY3006072 Participants received LY3006072 capsules starting at 1 milligram (mg) and escalating doses of 3 mg, 10 mg, 20 mg and 40 mg.	Drug: LY3006072; Capsules administered orally

Outcome Measures

Primary Outcome Measures

1. Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs [Baseline, up to 21 days]

   AEs that were considered possibly related to study drug, in the opinion of the investigator, were reported. A summary of serious and all other non-serious AEs, regardless of possible drug relatedness, is located in the Reported Adverse Event module.

Secondary Outcome Measures

1. Pharmacokinetics: Maximum Concentration (Cmax) of LY3006072 [Predose, 0.25, 0.5, 1, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 96 hours postdose]

2. Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3006072 [Predose, 0.25, 0.5, 1, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 96 hours postdose]

   PK: Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC[0-inf] of LY3006072.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Overtly healthy males or females, as determined by medical history and physical examination

• Male participants with a partner of childbearing potential must agree to use barrier protection during sexual intercourse while in the study and for 3 months after the last dose of study drug

• Women must not be pregnant or nursing and must be of non-childbearing potential, due to either surgical sterilization or menopause

• Body mass index between 19.0 and 30.0 kilograms per square meter (kg/m^2), inclusive

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: NCT01640249
• Other Study ID Numbers: 14372; I6B-MC-HZBA
• First Posted: Jul 13, 2012
• Last Update Posted: Aug 8, 2019
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No

Study Results

Participant Flow

Pre-assignment Detail	This was a 2-part (Part A and Part B) crossover study. Part A was a dose-escalation with up to 3-period crossover with 2 alternating cohorts (Cohorts 1 and 2). There was 14 days of washout time between each dose. Part B was not initiated as study was terminated early due to technical factors.

Arm/Group Title	Cohort 1 (Sequence 1)	Cohort 1 (Sequence 2)	Cohort 1 Sequence 3	Cohort 1 Sequence 4	Cohort 2 (Sequence 1)	Cohort 2 (Sequence 2)	Cohort 2 (Sequence 3)
Arm/Group Description	Participants received LY3006072 and Placebo capsules as per below dosing schedules. Period 1: 1 milligrams (mg) LY3006072, Period 2: 10 mg LY3006072 and Period 3: Placebo	Participants received LY3006072 and Placebo capsules as per below dosing schedules. Period 1: 1 mg LY3006072, Period 2: Placebo, Period 3: 40 mg LY3006072	Participants received LY3006072 and Placebo capsules as per below dosing schedule. Period 1: Placebo, Period 2: 10 mg LY3006072 and Period 3: 40 mg LY3006072	Participants received 1 mg, 10 mg and 40 mg of LY3006072 capsules as per below dosing schedule. Period 1: 1 mg LY3006072, Period 2: 10 mg LY3006072 and Period 3: 40 mg LY3006072	Participants received Placebo and 20 mg of LY3006072 capsules as per below dosing schedule. Period 1: Placebo and Period 2: 20 mg LY3006072	Participants received 3 mg and 20 mg of LY3006072 capsules as per below dosing schedule. Period 1: 3 mg LY3006072 and Period 2: 20 mg LY3006072	Participants received Placebo and 3 mg of LY3006072 capsules as per below dosing schedule. Period 1: 3 mg LY3006072 and Period 2: Placebo
Period Title: Period 1
STARTED	3	2	2	2	2	5	2
Received at Least 1 Dose of Study Drug	3	2	2	2	2	5	2
COMPLETED	2	2	2	2	2	4	2
NOT COMPLETED	1	0	0	0	0	1	0
Period Title: Period 1
STARTED	2	2	2	2	2	4	2
COMPLETED	2	2	2	2	2	4	2
NOT COMPLETED	0	0	0	0	0	0	0
Period Title: Period 1
STARTED	2	2	2	2	0	0	0
COMPLETED	2	2	2	1	0	0	0
NOT COMPLETED	0	0	0	1	0	0	0

Baseline Characteristics

Arm/Group Title	Cohort 1 (Sequence 1)	Cohort 1 (Sequence 2)	Cohort 1 (Sequence 3)	Cohort 1 (Sequence 4)	Cohort 2 (Sequence 1)	Cohort 2 (Sequence 2)	Cohort 2 (Sequence 3)	Total
Arm/Group Description	Participants received LY3006072 and Placebo capsules as per below dosing schedules. Period 1: 1 milligrams (mg) LY3006072, Period 2: 10 mg LY3006072 and Period 3: Placebo	Participants received LY3006072 and Placebo capsules as per below dosing schedules. Period 1: 1 mg LY3006072, Period 2: Placebo, Period 3: 40 mg LY3006072	Participants received LY3006072 and Placebo capsules as per below dosing schedule. Period 1: Placebo, Period 2: 10 mg LY3006072 and Period 3: 40 mg LY3006072	Participants received 1 mg, 10 mg and 40 mg of LY3006072 capsules as per below dosing schedule. Period 1: 1 mg LY3006072, Period 2: 10 mg LY3006072 and Period 3: 40 mg LY3006072	Participants received Placebo and 20 mg of LY3006072 capsules as per below dosing schedule. Period 1: Placebo and Period 2: 20 mg LY3006072	Participants received 3 mg and 20 mg of LY3006072 capsules as per below dosing schedule. Period 1: 3 mg LY3006072 and Period 2: 20 mg LY3006072	Participants received Placebo and 3 mg of LY3006072 capsules as per below dosing schedule. Period 1: 3 mg LY3006072 and Period 2: Placebo	Total of all reporting groups
Overall Participants	3	2	2	2	2	5	2	18
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	2 66.7%	0 0%	1 50%	2 100%	2 100%	3 60%	0 0%	10 55.6%
>=65 years	1 33.3%	2 100%	1 50%	0 0%	0 0%	2 40%	2 100%	8 44.4%
Sex: Female, Male (Count of Participants)
Female	1 33.3%	2 100%	2 100%	2 100%	1 50%	2 40%	2 100%	12 66.7%
Male	2 66.7%	0 0%	0 0%	0 0%	1 50%	3 60%	0 0%	6 33.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Not Hispanic or Latino	3 100%	2 100%	2 100%	2 100%	2 100%	5 100%	2 100%	18 100%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	1 33.3%	0 0%	0 0%	0 0%	0 0%	1 20%	0 0%	2 11.1%
White	2 66.7%	2 100%	2 100%	2 100%	2 100%	4 80%	2 100%	16 88.9%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	3 100%	2 100%	2 100%	2 100%	2 100%	5 100%	2 100%	18 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs
Description	AEs that were considered possibly related to study drug, in the opinion of the investigator, were reported. A summary of serious and all other non-serious AEs, regardless of possible drug relatedness, is located in the Reported Adverse Event module.
Time Frame	Baseline, up to 21 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	1 mg LY3006072	3 mg LY3006072	10 mg LY3006072	20 mg LY3006072	40 mg LY3006072
Arm/Group Description	Participants received placebo capsule orally with approximately 200 to 300 mL of room temperature water in the morning.	Participants received 1 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.	Participants received 3 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.	Participants received 10 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.	Participants received 20 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.	Participants received 40 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
Measure Participants	9	6	6	6	6	6
Serious AEs	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Other Non-Serious AEs	0 0%	3 150%	1 50%	1 50%	2 100%	6 120%

2. Secondary Outcome

Title	Pharmacokinetics: Maximum Concentration (Cmax) of LY3006072
Time Frame	Predose, 0.25, 0.5, 1, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 96 hours postdose

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and have evaluable PK data.

Arm/Group Title	1 mg LY3006072	3 mg LY3006072	10 mg LY3006072	20 mg LY3006072	40 mg LY3006072
Arm/Group Description	Participants received 1 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.	Participants received 3 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.	Participants received 10 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.	Participants received 20 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.	Participants received 40 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
Measure Participants	6	6	6	6	6
Geometric Mean (Geometric Coefficient of Variation) [nanograms per milliliter (ng/mL)]	18.8 (20)	57.0 (12)	160 (24)	263 (42)	576 (31)

3. Secondary Outcome

Title	Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3006072
Description	PK: Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC[0-inf] of LY3006072.
Time Frame	Predose, 0.25, 0.5, 1, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 96 hours postdose

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and have evaluable PK data.

Arm/Group Title	1 mg LY3006072	3 mg LY3006072	10 mg LY3006072	20 mg LY3006072	40 mg LY3006072
Arm/Group Description	Participants received 1 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.	Participants received 3 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.	Participants received 10 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.	Participants received 20 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.	Participants received 40 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
Measure Participants	6	6	6	6	6
Geometric Mean (Geometric Coefficient of Variation) [nanograms * hours per mL (ng*hr/mL)]	1530 (47)	4800 (34)	14400 (25)	24700 (27)	65600 (21)

Adverse Events

Time Frame	Up To 21 Days
Adverse Event Reporting Description	All randomized participants who received at least one dose of study drug.
Arm/Group Title	Placebo		1 mg LY3006072		3 mg LY3006072		10 mg LY3006072		20 mg LY3006072		40 mg LY3006072
Arm/Group Description	Participants received placebo capsule orally with approximately 200 to 300 mL of room temperature water in the morning.		Participants received 1 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.		Participants received 3 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.		Participants received 10 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.		Participants received 20 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.		Participants received 40 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
All Cause Mortality
	Placebo		1 mg LY3006072		3 mg LY3006072		10 mg LY3006072		20 mg LY3006072		40 mg LY3006072
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		1 mg LY3006072		3 mg LY3006072		10 mg LY3006072		20 mg LY3006072		40 mg LY3006072
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		1 mg LY3006072		3 mg LY3006072		10 mg LY3006072		20 mg LY3006072		40 mg LY3006072
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		3/6 (50%)		1/6 (16.7%)		1/6 (16.7%)		2/6 (33.3%)		6/6 (100%)
Gastrointestinal disorders
Dry mouth	0/9 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0
Nausea	0/9 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0
Musculoskeletal and connective tissue disorders
Back pain	0/9 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0
Muscular weakness	0/9 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1
Nervous system disorders
Dizziness	0/9 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	1/6 (16.7%)	1
Memory impairment	0/9 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1
Somnolence	0/9 (0%)	0	3/6 (50%)	3	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	6/6 (100%)	6
Psychiatric disorders
Insomnia	0/9 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0

Limitations/Caveats

Part B was not initiated as study was terminated early due to technical factors.

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.