Trial Outcomes & Findings for A Study of LY3006072 in Healthy Participants (NCT NCT01640249)

NCT ID: NCT01640249

Last Updated: 2019-08-08

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

18 participants

Primary outcome timeframe

Baseline, up to 21 days

Results posted on

2019-08-08

Participant Flow

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.

Participant milestones

Participant milestones
Measure
Cohort 1 (Sequence 1)
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
Cohort 1 (Sequence 2)
Participants received LY3006072 and Placebo capsules as per below dosing schedules. Period 1: 1 mg LY3006072, Period 2: Placebo, Period 3: 40 mg LY3006072
Cohort 1 Sequence 3
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
Cohort 1 Sequence 4
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
Cohort 2 (Sequence 1)
Participants received Placebo and 20 mg of LY3006072 capsules as per below dosing schedule. Period 1: Placebo and Period 2: 20 mg LY3006072
Cohort 2 (Sequence 2)
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
Cohort 2 (Sequence 3)
Participants received Placebo and 3 mg of LY3006072 capsules as per below dosing schedule. Period 1: 3 mg LY3006072 and Period 2: Placebo
Period 1
STARTED
3
2
2
2
2
5
2
Period 1
Received at Least 1 Dose of Study Drug
3
2
2
2
2
5
2
Period 1
COMPLETED
2
2
2
2
2
4
2
Period 1
NOT COMPLETED
1
0
0
0
0
1
0
Period 2
STARTED
2
2
2
2
2
4
2
Period 2
COMPLETED
2
2
2
2
2
4
2
Period 2
NOT COMPLETED
0
0
0
0
0
0
0
Period 3
STARTED
2
2
2
2
0
0
0
Period 3
COMPLETED
2
2
2
1
0
0
0
Period 3
NOT COMPLETED
0
0
0
1
0
0
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Cohort 1 (Sequence 1)
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
Cohort 1 (Sequence 2)
Participants received LY3006072 and Placebo capsules as per below dosing schedules. Period 1: 1 mg LY3006072, Period 2: Placebo, Period 3: 40 mg LY3006072
Cohort 1 Sequence 3
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
Cohort 1 Sequence 4
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
Cohort 2 (Sequence 1)
Participants received Placebo and 20 mg of LY3006072 capsules as per below dosing schedule. Period 1: Placebo and Period 2: 20 mg LY3006072
Cohort 2 (Sequence 2)
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
Cohort 2 (Sequence 3)
Participants received Placebo and 3 mg of LY3006072 capsules as per below dosing schedule. Period 1: 3 mg LY3006072 and Period 2: Placebo
Period 1
Withdrawal by Subject
1
0
0
0
0
1
0

Baseline Characteristics

A Study of LY3006072 in Healthy Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Cohort 2 (Sequence 2)
n=5 Participants
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
Cohort 2 (Sequence 3)
n=2 Participants
Participants received Placebo and 3 mg of LY3006072 capsules as per below dosing schedule. Period 1: 3 mg LY3006072 and Period 2: Placebo
Cohort 1 (Sequence 1)
n=3 Participants
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
Cohort 1 (Sequence 2)
n=2 Participants
Participants received LY3006072 and Placebo capsules as per below dosing schedules. Period 1: 1 mg LY3006072, Period 2: Placebo, Period 3: 40 mg LY3006072
Cohort 1 (Sequence 3)
n=2 Participants
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
Cohort 1 (Sequence 4)
n=2 Participants
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
Cohort 2 (Sequence 1)
n=2 Participants
Participants received Placebo and 20 mg of LY3006072 capsules as per below dosing schedule. Period 1: Placebo and Period 2: 20 mg LY3006072
Total
n=18 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=30 Participants
0 Participants
n=3 Participants
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=6 Participants
Age, Categorical
Between 18 and 65 years
3 Participants
n=30 Participants
0 Participants
n=3 Participants
2 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
2 Participants
n=7 Participants
2 Participants
n=31 Participants
10 Participants
n=6 Participants
Age, Categorical
>=65 years
2 Participants
n=30 Participants
2 Participants
n=3 Participants
1 Participants
n=99 Participants
2 Participants
n=107 Participants
1 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
8 Participants
n=6 Participants
Sex: Female, Male
Female
2 Participants
n=30 Participants
2 Participants
n=3 Participants
1 Participants
n=99 Participants
2 Participants
n=107 Participants
2 Participants
n=206 Participants
2 Participants
n=7 Participants
1 Participants
n=31 Participants
12 Participants
n=6 Participants
Sex: Female, Male
Male
3 Participants
n=30 Participants
0 Participants
n=3 Participants
2 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
1 Participants
n=31 Participants
6 Participants
n=6 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=30 Participants
0 Participants
n=3 Participants
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=6 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
5 Participants
n=30 Participants
2 Participants
n=3 Participants
3 Participants
n=99 Participants
2 Participants
n=107 Participants
2 Participants
n=206 Participants
2 Participants
n=7 Participants
2 Participants
n=31 Participants
18 Participants
n=6 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=30 Participants
0 Participants
n=3 Participants
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=6 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=30 Participants
0 Participants
n=3 Participants
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=6 Participants
Race (NIH/OMB)
Asian
0 Participants
n=30 Participants
0 Participants
n=3 Participants
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=6 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=30 Participants
0 Participants
n=3 Participants
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=6 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=30 Participants
0 Participants
n=3 Participants
1 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
2 Participants
n=6 Participants
Race (NIH/OMB)
White
4 Participants
n=30 Participants
2 Participants
n=3 Participants
2 Participants
n=99 Participants
2 Participants
n=107 Participants
2 Participants
n=206 Participants
2 Participants
n=7 Participants
2 Participants
n=31 Participants
16 Participants
n=6 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=30 Participants
0 Participants
n=3 Participants
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=6 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=30 Participants
0 Participants
n=3 Participants
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=6 Participants
Region of Enrollment
United States
5 Participants
n=30 Participants
2 Participants
n=3 Participants
3 Participants
n=99 Participants
2 Participants
n=107 Participants
2 Participants
n=206 Participants
2 Participants
n=7 Participants
2 Participants
n=31 Participants
18 Participants
n=6 Participants

PRIMARY outcome

Timeframe: Baseline, up to 21 days

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

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.

Outcome measures

Outcome measures
Measure
Placebo
n=9 Participants
Participants received placebo capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
1 mg LY3006072
n=6 Participants
Participants received 1 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
3 mg LY3006072
n=6 Participants
Participants received 3 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
10 mg LY3006072
n=6 Participants
Participants received 10 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
20 mg LY3006072
n=6 Participants
Participants received 20 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
40 mg LY3006072
n=6 Participants
Participants received 40 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs
Serious AEs
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs
Other Non-Serious AEs
0 Participants
3 Participants
1 Participants
1 Participants
2 Participants
6 Participants

SECONDARY outcome

Timeframe: Predose, 0.25, 0.5, 1, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 96 hours postdose

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

Outcome measures

Outcome measures
Measure
Placebo
n=6 Participants
Participants received placebo capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
1 mg LY3006072
n=6 Participants
Participants received 1 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
3 mg LY3006072
n=6 Participants
Participants received 3 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
10 mg LY3006072
n=6 Participants
Participants received 10 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
20 mg LY3006072
n=6 Participants
Participants received 20 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
40 mg LY3006072
Participants received 40 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
Pharmacokinetics: Maximum Concentration (Cmax) of LY3006072
18.8 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 20
57.0 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 12
160 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 24
263 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 42
576 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 31

SECONDARY outcome

Timeframe: Predose, 0.25, 0.5, 1, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 96 hours postdose

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

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

Outcome measures

Outcome measures
Measure
Placebo
n=6 Participants
Participants received placebo capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
1 mg LY3006072
n=6 Participants
Participants received 1 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
3 mg LY3006072
n=6 Participants
Participants received 3 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
10 mg LY3006072
n=6 Participants
Participants received 10 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
20 mg LY3006072
n=6 Participants
Participants received 20 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
40 mg LY3006072
Participants received 40 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3006072
1530 nanograms * hours per mL (ng*hr/mL)
Geometric Coefficient of Variation 47
4800 nanograms * hours per mL (ng*hr/mL)
Geometric Coefficient of Variation 34
14400 nanograms * hours per mL (ng*hr/mL)
Geometric Coefficient of Variation 25
24700 nanograms * hours per mL (ng*hr/mL)
Geometric Coefficient of Variation 27
65600 nanograms * hours per mL (ng*hr/mL)
Geometric Coefficient of Variation 21

Adverse Events

Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

1 mg LY3006072

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

3 mg LY3006072

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

10 mg LY3006072

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

20 mg LY3006072

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

40 mg LY3006072

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Placebo
n=9 participants at risk
Participants received placebo capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
1 mg LY3006072
n=6 participants at risk
Participants received 1 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
3 mg LY3006072
n=6 participants at risk
Participants received 3 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
10 mg LY3006072
n=6 participants at risk
Participants received 10 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
20 mg LY3006072
n=6 participants at risk
Participants received 20 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
40 mg LY3006072
n=6 participants at risk
Participants received 40 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
Gastrointestinal disorders
Dry mouth
0.00%
0/9 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
Gastrointestinal disorders
Nausea
0.00%
0/9 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/9 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders
Muscular weakness
0.00%
0/9 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
Nervous system disorders
Dizziness
0.00%
0/9 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
Nervous system disorders
Memory impairment
0.00%
0/9 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
Nervous system disorders
Somnolence
0.00%
0/9 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
50.0%
3/6 • Number of events 3 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
100.0%
6/6 • Number of events 6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
Psychiatric disorders
Insomnia
0.00%
0/9 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: GT60