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A Safety Study of LY2886721 Single Doses in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01133405
Recruitment Status : Completed
First Posted : May 28, 2010
Results First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition Alzheimer's Disease
Interventions Drug: LY2886721
Drug: Placebo
Enrollment 40
Recruitment Details  
Pre-assignment Details The study consists of 2-parts. Part A was a cross-over study and was conducted in 2 alternating cohorts (Cohorts A and B). Part B was a single-dose, single period study in 2 cohorts (Cohorts C and D). All doses were administered in the fasted state, unless otherwise indicated. Each oral dose was followed by a washout period of at least 14 days.
Arm/Group Title Cohort A (Part 1) : Sequence 1 Cohort A (Part 1): Sequence 2 Cohort A (Part 1): Sequence 3 Cohort B (Part 1): Sequence 1 Cohort B (Part 1): Sequence 2 Cohort B (Part 1): Sequence 3 Cohort C (Part 2): 10mg LY2886721 Cohort C (Part 2): Placebo Cohort D (Part 2): 35 mg LY2886721 Cohort D (Part 2): Placebo
Hide Arm/Group Description

Participants received Placebo, 15 milligram (mg) LY2886721 and 35 mg LY2886721 orally as per the below dosing sequence in each period.

Period 1: Placebo, Period 2: 15 mg LY2886721 and Period 3: 35 mg LY2886721.

Participants received 1 mg LY2886721, 15 mg LY2886721 and placebo orally as per the below dosing sequence in each period.

Period 1: 1 mg LY2886721, Period 2: 15 mg LY2886721 and Period 3: Placebo.

Participants received 1 mg LY2886721, placebo and 35 mg LY2886721 orally as per the below dosing sequence in each period.

Period 1: 1 mg LY2886721, Period 2: Placebo and Period 3: 35 mg LY2886721.

Participants received 7 mg LY2886721, 25 mg LY2886721 and placebo and orally as per the below dosing sequence in each period.

Period 1: 7 mg LY2886721, Period 2: 25 mg LY2886721 and Period 3: Placebo.

Participants received 7 mg LY2886721, placebo and 7 mg LY2886721 (fed state) orally as per the below dosing sequence in each period.

Period 1: 7 mg LY2886721 Period 2: Placebo and Period 3: 7 mg LY2886721 (fed state).

Participants received Placebo, 25 mg LY2886721 and 7 mg LY2886721 (fed state) orally as per the below dosing sequence in each period.

Period 1: Placebo, Period 2: 25 mg LY2886721 and Period 3: 7 mg LY2886721 (fed state).

Participants received a single 10 mg LY2886721 oral dose (low dose) in the fasted state. Participants received a single oral placebo dose in the fasted state. Participants received a single 35 mg LY2886721 oral dose (high dose) in the fasted state. Participants received a single oral placebo dose in the fasted state.
Period Title: Period 1
Started 3 6 5 5 3 5 5 2 4 2
Safety Analysis Population 2 [1] 6 5 5 3 5 5 2 4 2
Received at Least 1 Dose of Drug 2 4 4 3 3 4 4 2 4 2
Completed 2 3 4 1 3 3 4 2 4 2
Not Completed 1 3 1 4 0 2 1 0 0 0
Reason Not Completed
Withdrawal by Subject             0             1             0             1             0             1             0             0             0             0
Physician Decision             0             0             0             1             0             0             0             0             0             0
Discontinued after randomization             1             0             0             0             0             0             1             0             0             0
Received drug only in period 2             0             1             0             2             0             1             0             0             0             0
Received drug only in period 3             0             1             1             0             0             0             0             0             0             0
[1]
One discontinued from study after randomization but before any study procedures.
Period Title: Period 2
Started 2 4 [1] 4 3 [2] 3 4 [3] 0 [4] 0 [4] 0 [5] 0 [5]
Received at Least 1 Dose of Study Drug 2 4 4 3 3 4 0 0 0 0
Completed 2 3 3 2 3 2 0 0 0 0
Not Completed 0 1 1 1 0 2 0 0 0 0
Reason Not Completed
Adverse Event             0             0             1             0             0             0             0             0             0             0
Withdrawal by Subject             0             0             0             1             0             1             0             0             0             0
Entry Criteria Not Met             0             1             0             0             0             0             0             0             0             0
Physician Decision             0             0             0             0             0             1             0             0             0             0
[1]
One participant started and received 15 mg LY2886721 only in period 2.
[2]
Two participants started and received 25 mg LY2886721 only in period 2.
[3]
One participant started and received 25 mg LY2886721 only in period 2.
[4]
Cohort C was planned only for single period.
[5]
Cohort D was planned only for single period.
Period Title: Period 3
Started 2 4 [1] 4 [2] 2 3 2 0 0 0 0
Received at Least 1 Dose of Study Drug 2 4 4 2 3 2 0 0 0 0
Completed 2 4 4 2 3 2 0 0 0 0
Not Completed 0 0 0 0 0 0 0 0 0 0
[1]
One participant started and received placebo only in period 3.
[2]
One participant started and received 35 mg LY2886721 only in period 3.
Arm/Group Title Cohort A (Part 1): Sequence 1 Cohort A (Part 1): Sequence 2 Cohort A (Part 1): Sequence 3 Cohort B (Part 1): Sequence 1 Cohort B (Part 1): Sequence 2 Cohort B (Part 1): Sequence 3 Cohort C (Part 2): 10mg LY2886721 Cohort C (Part 2): Placebo Cohort D (Part 2): 35 mg LY2886721 Cohort D (Part 2): Placebo Total
Hide Arm/Group Description Participants received Placebo, 15 milligram (mg) LY2886721 and 35 mg LY2886721 orally as per the dosing sequence in each period. Participants received 1 mg LY2886721, 15 mg LY2886721 and placebo orally as per the dosing sequence in each period. Participants received 1 mg LY2886721, placebo and 35 mg LY2886721 orally as per the dosing sequence in each period. Participants received 7 mg LY2886721, 25 mg LY2886721 and placebo and orally as per the dosing sequence in each period. Participants received 7 mg LY2886721, placebo and 7 mg LY2886721 (fed state) orally as per the dosing sequence in each period. Participants received Placebo, 25 mg LY2886721 and 7 mg LY2886721 (fed state) orally as per the below dosing sequence in each period. Participants received a single 10 mg LY2886721 oral dose (low dose) in the fasted state. .Participants received a single oral placebo dose in the fasted state. Participants received a single 35 mg LY2886721 oral dose (high dose) in the fasted state. Participants received a single oral placebo dose in the fasted state. Total of all reporting groups
Overall Number of Baseline Participants 2 6 5 5 3 5 5 2 4 2 39
Hide Baseline Analysis Population Description
Safety analysis population
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 6 participants 5 participants 5 participants 3 participants 5 participants 5 participants 2 participants 4 participants 2 participants 39 participants
<=18 years 0 0 0 0 0 0 0 0 0 0 0
Between 18 and 65 years 2 6 5 5 3 5 5 2 4 2 39
>=65 years 0 0 0 0 0 0 0 0 0 0 0
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 6 participants 5 participants 5 participants 3 participants 5 participants 5 participants 2 participants 4 participants 2 participants 39 participants
Female 0 0 3 0 2 0 1 1 0 0 7
Male 2 6 2 5 1 5 4 1 4 2 32
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 6 participants 5 participants 5 participants 3 participants 5 participants 5 participants 2 participants 4 participants 2 participants 39 participants
American Indian or Alaska Native 0 0 0 1 0 0 0 0 1 0 2
Asian 1 3 1 3 0 3 0 0 0 0 11
Native Hawaiian or Other Pacific Islander 0 0 0 0 0 0 0 0 0 0 0
Black or African American 0 2 0 1 0 2 4 2 1 1 13
White 1 1 3 0 2 0 1 0 2 1 11
More than one race 0 0 1 0 1 0 0 0 0 0 2
Unknown or Not Reported 0 0 0 0 0 0 0 0 0 0 0
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 2 participants 6 participants 5 participants 5 participants 3 participants 5 participants 5 participants 2 participants 4 participants 2 participants 39 participants
2 6 5 5 3 5 5 2 4 2 39
1.Primary Outcome
Title Number of Participants With Clinically Significant Effects (Adverse Events)
Hide Description A summary of serious adverse events and other nonserious adverse events located in Reported Adverse Event section. To assess effect of food on pharmacokinetics of LY2886721, participants in Cohort B during Period 3 (1 period=8 days) of Part 1 fasted overnight for at least 8 hours prior to receiving a single 7-milligram (mg) oral dose of LY2886721 in the fed state (Part 1 - Fed). Participants in other LY2886721 groups received LY2886721 in fasted state. Due to crossover design in Part 1, results reported by treatment; thus, participants are included in multiple arms.
Time Frame Predose to 10-14 days after final dose of study drug (up to 42 days)
Hide Outcome Measure Data
Hide Analysis Population Description
39 of the 40 participants who were entered and randomized into the study and who had undergone study procedures were included in the safety analyses. One participant, who was entered and randomized into the study but did not undergo study procedures, was excluded from the analysis.
Arm/Group Title Placebo (Part 1) 1 mg LY2886721 (Part 1) 7 mg LY2886721 (Part 1 - Fed and Fasted) 10 mg LY2886721 (Part 2) 15 mg LY2886721 (Part 1) 25 mg LY2886721 (Part 1) 35 mg LY2886721 (Part 1) 35 mg LY2886721 (Part 2) Placebo (Part 2)
Hide Arm/Group Description:
In a single 8-day period, participants received a single placebo oral dose after an overnight fast.
In a single 8-day period, participants received a single 1-mg LY2886721 oral dose after an overnight fast.

In a single 8-day period, participants received a single 7-mg LY2886721 oral dose after an overnight fast, but 15 minutes after completing breakfast (Fed).

In a single 8-day period, participants received a single 7-mg LY2886721 oral dose after an overnight fast (Fasted).

Participants received a single 10-mg LY2886721 oral dose after an overnight fast.
In a single 8-day period, participants received a single 15-mg LY2886721 oral dose after an overnight fast.
In a single 8-day period, participants received a single 25-mg LY2886721 oral dose after an overnight fast.
In a single 8-day period, participants received a single 35-mg LY2886721 oral dose after an overnight fast.
Participants received a single 35-mg LY2886721 oral dose after an overnight fast.
Participants received a single placebo oral dose after an overnight fast.
Overall Number of Participants Analyzed 19 8 8 4 6 7 6 4 4
Measure Type: Count of Participants
Unit of Measure: Participants
Serious Adverse Events 0 0 0 0 0 0 0 0 0
Other Nonserious Adverse Events 4 2 1 1 0 1 3 4 3
2.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of LY2886721
Hide Description To assess effect of food on pharmacokinetics of LY2886721, participants in Cohort B during Period 3 (1 period=8 days) of Part 1 fasted overnight for at least 8 hours prior to receiving a single 7-milligram (mg) oral dose of LY2886721 in the fed state (Part 1 - Fed). Participants in the other LY2886721 groups received LY2886721 in the fasted state. Due to the crossover design in Part 1, results are reported by treatment; therefore, participants are included in multiple arms.
Time Frame 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60 and 96 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of LY2886721 and have evaluable pharmacokinetic data were included in the analysis. One participant from Part 2, who experienced an adverse event before receiving study medication, was not included in the analysis.
Arm/Group Title 1 mg LY2886721 (Part 1) 7 mg LY2886721 Fed (Part 1) 7 mg LY2886721 Fasted (Part 1) 10 mg LY2886721 (Part 2) 15 mg LY2886721 (Part 1) 25 mg LY2886721 (Part 1) 35 mg LY2886721 (Part 1) 35 mg LY2886721 (Part 2)
Hide Arm/Group Description:
In a single 8-day period, participants received a single 1-mg LY2886721 oral dose after an overnight fast.
In a single 8-day period, participants received a single 7-mg LY2886721 oral dose after an overnight fast, but 15 minutes after completing breakfast.
In a single 8-day period, participants received a single 7-mg LY2886721 oral dose after an overnight fast.
Participants received a single 10-mg LY2886721 oral dose after an overnight fast.
In a single 8-day period, participants received a single 15-mg LY2886721 oral dose after an overnight fast.
In a single 8-day period, participants received a single 25-mg LY2886721 oral dose after an overnight fast.
In a single 8-day period, participants received a single 35-mg LY2886721 oral dose after an overnight fast.
Participants received a single 35-mg LY2886721 oral dose after an overnight fast.
Overall Number of Participants Analyzed 8 5 6 4 6 7 6 4
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram per milliliter (ng/mL)
1.9
(65%)
22.5
(23%)
18.2
(64%)
6.6
(60%)
41.6
(24%)
79.1
(25%)
78.2
(45%)
53.3
(44%)
3.Secondary Outcome
Title Plasma Concentration of LY2886721: Area Under the Concentration Versus Time Curve (AUC)
Hide Description Pharmacokinetic AUC for LY2886721 from time 0 to infinity. To assess effect of food on pharmacokinetics of LY2886721, participants in Cohort B during Period 3 (1 period=8 days) of Part 1 fasted overnight for at least 8 hours prior to receiving a single 7-milligram (mg) oral dose of LY2886721 in the fed state (Part 1 - Fed). Participants in the other LY2886721 groups received LY2886721 in the fasted state. Due to the crossover design in Part 1, results are reported by treatment; therefore, participants are included in multiple arms.
Time Frame 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60 and 96 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of LY2886721 and have evaluable pharmacokinetic data were included in the analysis. One participant in Part 2, who experienced an adverse event before receiving study medication, was not included in the analysis.
Arm/Group Title 1 mg LY2886721 (Part 1) 7 mg LY2886721 Fed (Part 1) 7 mg LY2886721 Fasted (Part 1) 10 mg LY2886721 (Part 2) 15 mg LY2886721 (Part 1) 25 mg LY2886721 (Part 1) 35 mg LY2886721 (Part 1) 35 mg LY2886721 (Part 2)
Hide Arm/Group Description:
In a single 8-day period, participants received a single 1-mg LY2886721 oral dose after an overnight fast.
In a single 8-day period, participants received a single 7-mg LY2886721 oral dose after an overnight fast, but 15 minutes after completing breakfast.
In a single 8-day period, participants received a single 7-mg LY2886721 oral dose after an overnight fast.
Participants received a single 10-mg LY2886721 oral dose after an overnight fast.
In a single 8-day period, participants received a single 15-mg LY2886721 oral dose after an overnight fast.
In a single 8-day period, participants received a single 25-mg LY2886721 oral dose after an overnight fast.
In a single 8-day period, participants received a single 35-mg LY2886721 oral dose after an overnight fast.
Participants received a single 35-mg LY2886721 oral dose after an overnight fast.
Overall Number of Participants Analyzed 8 5 6 4 6 7 6 4
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram*hour per milliliter (ng*h/mL)
NA [1] 
(NA%)
311
(14%)
212
(41%)
144
(580%)
468
(20%)
926
(16%)
954
(37%)
800
(38%)
[1]
Data for the 1-mg LY2886721 group are not presented for this outcome measure because sufficient data did not exist for the terminal elimination phase calculations.
4.Secondary Outcome
Title Pharmacodynamic Biomarker: Plasma Amyloid Beta (Aβ) 1-40 Concentration (Part 1 Only)
Hide Description Plasma concentrations of Aβ1-40 were based on the lowest observed/measured concentration (Cnadir). To assess effect of food on pharmacokinetics of LY2886721, participants in Cohort B during Period 3 (1 period=8 days) of Part 1 fasted overnight for at least 8 hours prior to receiving a single 7-milligram (mg) oral dose of LY2886721 in the fed state (Part 1 - Fed). Participants in the other LY2886721 groups received LY2886721 in the fasted state. Due to the crossover design in Part 1, results are reported by treatment; therefore, participants are included in multiple arms.
Time Frame 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60 and 96 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of LY2886721 in Part 1 and have evaluable pharmacodynamic data were included in the analysis. One participant who was entered and randomized into the study but did not undergo study procedures, was excluded from the analysis.
Arm/Group Title Placebo (Part 1) 1 mg LY2886721 (Part 1) 7 mg LY2886721 (Part 1 - Fed and Fasted) 15 mg LY2886721 (Part 1) 25 mg LY2886721 (Part 1) 35 mg LY2886721 (Part 1)
Hide Arm/Group Description:
In a single 8-day period, participants received a single placebo oral dose after an overnight fast.
In a single 8-day period, participants received a single 1-mg LY2886721 oral dose after an overnight fast.

In a single 8-day period, participants received a single 7-mg LY2886721 oral dose after an overnight fast, but 15 minutes after completing breakfast (Fed).

In a single 8-day period, participants received a single 7-mg LY2886721 oral dose after an overnight fast (Fasted).

In a single 8-day period, participants received a single 15-mg LY2886721 oral dose after an overnight fast.
In a single 8-day period, participants received a single 25-mg LY2886721 oral dose after an overnight fast.
In a single 8-day period, participants received a single 35-mg LY2886721 oral dose after an overnight fast.
Overall Number of Participants Analyzed 19 8 6 6 7 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: picogram per milliliter (pg/mL)
121
(23.6%)
80
(19.5%)
56
(41.3%)
35
(37.7%)
34
(28.4%)
36
(11.7%)
5.Secondary Outcome
Title Cerebrospinal Fluid (CSF) Maximum Observed Drug Concentration (Cmax) of LY2886721 (Part 2 Only)
Hide Description [Not Specified]
Time Frame Predose and up to 36 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of LY2886721 in Part 2 and have evaluable pharmacokinetic data were included in the analysis. One participant, who experienced an adverse event before receiving study medication, was not included in the analysis.
Arm/Group Title 10 mg LY2886721 (Part 2) 35 mg LY2886721 (Part 2)
Hide Arm/Group Description:
Participants received a single 10-mg LY2886721 oral dose after an overnight fast.
Participants received a single 35-mg LY2886721 oral dose by mouth after an overnight fast.
Overall Number of Participants Analyzed 4 4
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram per milliliter (ng/mL)
0.93
(60%)
5.99
(39%)
6.Secondary Outcome
Title Cerebrospinal Fluid (CSF) Pharmacodynamic Biomarker Amyloid Beta (Aβ) 1-40 Concentration (Part 2 Only)
Hide Description CSF Aβ 1-40 concentration was based on the lowest observed/measured concentration (Cnadir).
Time Frame Predose and up to 36 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of LY2886721 in Part 2 and have evaluable pharmacodynamic data were included in the analysis. One participant, who experienced an adverse event before receiving study medication, was not included in the analysis.
Arm/Group Title 10 mg LY2886721 (Part 2) 35 mg LY2886721 (Part 2) Placebo (Part 2)
Hide Arm/Group Description:
Participants received a single 10-mg LY2886721 oral dose after an overnight fast.
Participants received a single 35-mg LY2886721 oral dose after an overnight fast.
Participants received a single placebo oral dose after an overnight fast.
Overall Number of Participants Analyzed 4 4 4
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: picogram per milliliter (pg/mL)
8080
(48.8%)
5650
(51.1%)
7150
(62.4%)
7.Secondary Outcome
Title Cerebrospinal Fluid (CSF) Area Under the Concentration Versus Time Curve (AUC) of LY2886721 (Part 2 Only)
Hide Description [Not Specified]
Time Frame Predose and up to 36 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of LY2886721 in Part 2 and have evaluable pharmacokinetic data were included in the analysis. One participant, who experienced an adverse event before receiving study medication, was not included in the analysis.
Arm/Group Title 10 mg LY2886721 (Part 2) 35 mg LY2886721 (Part 2)
Hide Arm/Group Description:
Participants received a single 10-mg LY2886721 oral dose after an overnight fast.
Participants received a single 35-mg LY2886721 oral dose after an overnight fast.
Overall Number of Participants Analyzed 4 4
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram*hour per milliliter (ng*h/mL)
27
(89%)
121
(30%)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo (Part 1) 1 mg LY2886721 (Part 1) 7 mg LY2886721 (Part 1 - Fed and Fasted) 10 mg LY2886721 (Part 2) 15 mg LY2886721 (Part 1) 25 mg LY2886721 (Part 1) 35 mg LY2886721 (Part 1) 35 mg LY2886721 (Part 2) Placebo (Part 2)
Hide Arm/Group Description In a single 8-day period, participants received a single placebo oral dose after an overnight fast. In a single 8-day period, participants received a single 1-mg LY2886721 oral dose after an overnight fast.

In a single 8-day period, participants received a single 7-mg LY2886721 oral dose after an overnight fast, but 15 minutes after breakfast (Fed).

In a single 8-day period, participants received a single 7-mg LY2886721 oral dose after an overnight fast (Fasted).

Participants received a single 10-mg LY2886721 oral dose after an overnight fast. In a single 8-day period, participants received a single 15-mg LY2886721 oral dose after an overnight fast. In a single 8-day period, participants received a single 25-mg LY2886721 oral dose after an overnight fast. In a single 8-day period, participants received a single 35-mg LY2886721 oral dose after an overnight fast. Participants received a single 35-mg LY2886721 oral dose after an overnight fast. Participants received a single placebo oral dose after an overnight fast.
All-Cause Mortality
Placebo (Part 1) 1 mg LY2886721 (Part 1) 7 mg LY2886721 (Part 1 - Fed and Fasted) 10 mg LY2886721 (Part 2) 15 mg LY2886721 (Part 1) 25 mg LY2886721 (Part 1) 35 mg LY2886721 (Part 1) 35 mg LY2886721 (Part 2) Placebo (Part 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Placebo (Part 1) 1 mg LY2886721 (Part 1) 7 mg LY2886721 (Part 1 - Fed and Fasted) 10 mg LY2886721 (Part 2) 15 mg LY2886721 (Part 1) 25 mg LY2886721 (Part 1) 35 mg LY2886721 (Part 1) 35 mg LY2886721 (Part 2) Placebo (Part 2)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events 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   0/19 (0.00%)      0/8 (0.00%)      0/8 (0.00%)      0/4 (0.00%)      0/6 (0.00%)      0/7 (0.00%)      0/6 (0.00%)      0/4 (0.00%)      0/4 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo (Part 1) 1 mg LY2886721 (Part 1) 7 mg LY2886721 (Part 1 - Fed and Fasted) 10 mg LY2886721 (Part 2) 15 mg LY2886721 (Part 1) 25 mg LY2886721 (Part 1) 35 mg LY2886721 (Part 1) 35 mg LY2886721 (Part 2) Placebo (Part 2)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events 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   4/19 (21.05%)      2/8 (25.00%)      1/8 (12.50%)      1/4 (25.00%)      0/6 (0.00%)      1/7 (14.29%)      3/6 (50.00%)      4/4 (100.00%)      3/4 (75.00%)    
Ear and labyrinth disorders                   
Ear discomfort  1  1/19 (5.26%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0
Vertigo  1  0/19 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0
Gastrointestinal disorders                   
Nausea  1  1/19 (5.26%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0
General disorders                   
Chest pain  1  0/19 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1
Puncture site pain  1  0/19 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 1/4 (25.00%)  2 0/4 (0.00%)  0
Vessel puncture site haematoma  1  1/19 (5.26%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0
Injury, poisoning and procedural complications                   
Procedural headache  1  0/19 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 4/4 (100.00%)  5 1/4 (25.00%)  1
Procedural vomiting  1  0/19 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0
Musculoskeletal and connective tissue disorders                   
Arthralgia  1  0/19 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0
Muscle spasms  1  0/19 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0
Pain in extremity  1  0/19 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0
Plantar fasciitis  1  1/19 (5.26%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0
Nervous system disorders                   
Dizziness  1  1/19 (5.26%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0
Dysgeusia  1  0/19 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0
Headache  1  1/19 (5.26%)  1 1/8 (12.50%)  1 0/8 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1
Syncope  1  0/19 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1
Psychiatric disorders                   
Anxiety  1  0/19 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                   
Rhinitis allergic  1  0/19 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0
Skin and subcutaneous tissue disorders                   
Dermatitis contact  1  1/19 (5.26%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
EMail: ClinicalTrials.gov@lilly.com
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01133405    
Other Study ID Numbers: 13733
I4O-MC-BACA ( Other Identifier: Eli Lilly and Company )
First Submitted: May 27, 2010
First Posted: May 28, 2010
Results First Submitted: May 20, 2019
Results First Posted: September 16, 2019
Last Update Posted: September 16, 2019