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A Safety Study of LY2886721 Multiple 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: NCT01227252
Recruitment Status : Completed
First Posted : October 25, 2010
Results First Posted : July 19, 2019
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition Alzheimer's Disease
Interventions Drug: LY2886721
Drug: Placebo
Enrollment 42
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo 5 mg LY2886721 15 mg LY2886721 35 mg LY2886721
Hide Arm/Group Description Placebo was administered orally as capsules, once daily for 14 days. A 5-milligram (mg) dose of LY2886721 was administered orally as capsules, once daily for 14 days. A 15-mg dose of LY2886721 was administered orally as capsules, once daily for 14 days. A 35-mg dose of LY2886721 was administered orally as capsules, once daily for 14 days.
Period Title: Overall Study
Started 12 10 10 10
Received at Least 1 Dose of Study Drug 12 10 10 10
Completed 12 7 10 10
Not Completed 0 3 0 0
Reason Not Completed
Sponsor Decision             0             1             0             0
Lost to Follow-up             0             1             0             0
Withdrawal by Subject             0             1             0             0
Arm/Group Title Placebo 5 mg LY2886721 15 mg LY2886721 35 mg LY2886721 Total
Hide Arm/Group Description Placebo was administered orally as capsules, once daily for 14 days. A 5-milligram (mg) dose of LY2886721 was administered orally as capsules, once daily for 14 days. A 15-mg dose of LY2886721 was administered orally as capsules, once daily for 14 days. A 35-mg dose of LY2886721 was administered orally as capsules, once daily for 14 days. Total of all reporting groups
Overall Number of Baseline Participants 12 10 10 10 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 10 participants 10 participants 10 participants 42 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
 100.0%
10
 100.0%
10
 100.0%
10
 100.0%
42
 100.0%
>=65 years
0
   0.0%
0
   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 12 participants 10 participants 10 participants 10 participants 42 participants
Female
0
   0.0%
1
  10.0%
1
  10.0%
1
  10.0%
3
   7.1%
Male
12
 100.0%
9
  90.0%
9
  90.0%
9
  90.0%
39
  92.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 10 participants 10 participants 10 participants 42 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
4
  33.3%
5
  50.0%
2
  20.0%
3
  30.0%
14
  33.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  16.7%
2
  20.0%
3
  30.0%
1
  10.0%
8
  19.0%
White
6
  50.0%
3
  30.0%
5
  50.0%
6
  60.0%
20
  47.6%
More than one race
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%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 12 participants 10 participants 10 participants 10 participants 42 participants
12
 100.0%
10
 100.0%
10
 100.0%
10
 100.0%
42
 100.0%
1.Primary Outcome
Title Number of Participants With Clinically Significant Effects
Hide Description Clinically significant effects were defined as serious and nonserious adverse events. A summary of serious and all other nonserious adverse events is located in the Reported Adverse Event module. The number of participants with at least 1 adverse event in each treatment arm is reported for this outcome measure.
Time Frame Predose up to Day 70
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants were included in the analysis.
Arm/Group Title Placebo 5 mg LY2886721 15 mg LY2886721 35 mg LY2886721
Hide Arm/Group Description:
Placebo was administered orally as capsules, once daily for 14 days.
A 5-milligram (mg) dose of LY2886721 was administered orally as capsules, once daily for 14 days.
A 15-mg dose of LY2886721 was administered orally as capsules, once daily for 14 days.
A 35-mg dose of LY2886721 was administered orally as capsules, once daily for 14 days.
Overall Number of Participants Analyzed 12 10 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
Serious Adverse Events 0 0 0 0
Nonserious Adverse Events 2 2 3 3
2.Secondary Outcome
Title Plasma Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY2886721
Hide Description [Not Specified]
Time Frame Predose (Day 14) up to Day 19
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received study drug on Day 14 and had evaluable pharmacokinetic data were included in the analysis.
Arm/Group Title 5 mg LY2886721 15 mg LY2886721 35 mg LY2886721
Hide Arm/Group Description:
Participants received a 5-mg oral dose of LY2886721 capsules, once daily for 14 days.
Participants received a 10-mg oral dose of LY2886721 capsules, once daily for 14 days.
Participants received a 35-mg oral dose of LY2886721 capsules, once daily for 14 days.
Overall Number of Participants Analyzed 9 10 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram per milliliter (ng/mL)
11.6
(48%)
43.0
(24%)
80.0
(43%)
3.Secondary Outcome
Title Plasma Area Under the Concentration Versus Time Curve (AUC) of LY2886721
Hide Description Area under the concentration versus time curve during 1 dosing interval (1 dosing interval=24 hours) at steady state (AUCτ,ss) is being reported for this outcome measure.
Time Frame Predose (Day 14) to 24 Hours post-dose (Day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received study drug on Day 14 and had evaluable pharmacokinetic data were included in the analysis.
Arm/Group Title 5 mg LY2886721 15 mg LY2886721 35 mg LY2886721
Hide Arm/Group Description:
Participants received a 5-mg oral dose of LY2886721 capsules, once daily for 14 days.
Participants received a 10-mg oral dose of LY2886721 capsules, once daily for 14 days.
Participants received a 35-mg oral dose of LY2886721 capsules, once daily for 14 days.
Overall Number of Participants Analyzed 9 10 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram*hour per milliliter (ng*h/mL)
128
(41%)
447
(23%)
861
(38%)
4.Secondary Outcome
Title Plasma Amyloid Beta (Aβ) 1-40 Concentration
Hide Description The minimum concentration (Cnadir) is being reported for this outcome measure.
Time Frame Predose (Day 14) up to Day 19
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received study drug on Day 14 and had evaluable pharmacodynamic data were included in the analysis.
Arm/Group Title Placebo 5 mg LY2886721 15 mg LY2886721 35 mg LY2886721
Hide Arm/Group Description:
Placebo was administered orally as capsules, once daily for 14 days.
A 5-milligram (mg) dose of LY2886721 was administered orally as capsules, once daily for 14 days.
A 15-mg dose of LY2886721 was administered orally as capsules, once daily for 14 days.
A 35-mg dose of LY2886721 was administered orally as capsules, once daily for 14 days.
Overall Number of Participants Analyzed 12 9 10 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: picogram per milliliter (pg/mL)
123
(14.5%)
49
(55.1%)
40
(19.7%)
25
(28.1%)
5.Secondary Outcome
Title Cerebrospinal Fluid (CSF) Concentration of LY2886721
Hide Description [Not Specified]
Time Frame 24 Hours post-dose (Day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
A subset of all participants who received study drug on Day 14 and had evaluable pharmacodynamic data was included in the analysis.
Arm/Group Title 5 mg LY2886721 15 mg LY2886721 35 mg LY2886721
Hide Arm/Group Description:
Participants received a 5-mg oral dose of LY2886721 capsules, once daily for 14 days.
Participants received a 10-mg oral dose of LY2886721 capsules, once daily for 14 days.
Participants received a 35-mg oral dose of LY2886721 capsules, once daily for 14 days.
Overall Number of Participants Analyzed 4 4 4
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram per milliliter (ng/mL)
0.5
(64.5%)
1.4
(16.6%)
3.8
(22.6%)
6.Secondary Outcome
Title Change From Baseline to Day 15 Endpoint in Cerebrospinal Fluid (CSF) Amyloid Beta (Aβ) 1-40 Concentration
Hide Description The Least Squares means were adjusted for baseline concentration.
Time Frame Predose (Day 14), 24 Hours post-dose (Day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received study drug on Day 14 and had evaluable pharmacodynamic data were included in the analysis.
Arm/Group Title Placebo 5 mg LY2886721 15 mg LY2886721 35 mg LY2886721
Hide Arm/Group Description:
Placebo was administered orally as capsules, once daily for 14 days.
A 5-milligram (mg) dose of LY2886721 was administered orally as capsules, once daily for 14 days.
A 15-mg dose of LY2886721 was administered orally as capsules, once daily for 14 days.
A 35-mg dose of LY2886721 was administered orally as capsules, once daily for 14 days.
Overall Number of Participants Analyzed 12 10 10 10
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent change (%)
-3.9
(-9.1 to 1.3)
-11.8
(-16.1 to -7.4)
-27.5
(-31.6 to -23.5)
-59.1
(-67.0 to -51.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo 5 mg LY2886721 15 mg LY2886721 35 mg LY2886721
Hide Arm/Group Description Placebo was administered orally as capsules, once daily for 14 days. A 5-milligram (mg) dose of LY2886721 was administered orally as capsules, once daily for 14 days. A 15-mg dose of LY2886721 was administered orally as capsules, once daily for 14 days. A 35-mg dose of LY2886721 was administered orally as capsules, once daily for 14 days.
All-Cause Mortality
Placebo 5 mg LY2886721 15 mg LY2886721 35 mg LY2886721
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Placebo 5 mg LY2886721 15 mg LY2886721 35 mg LY2886721
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/10 (0.00%)      0/10 (0.00%)      0/10 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo 5 mg LY2886721 15 mg LY2886721 35 mg LY2886721
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/12 (16.67%)      2/10 (20.00%)      3/10 (30.00%)      3/10 (30.00%)    
Gastrointestinal disorders         
Gingivitis  1  1/12 (8.33%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
General disorders         
Chest pain  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Infections and infestations         
Oral herpes  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Viral infection  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Injury, poisoning and procedural complications         
Procedural headache  1  1/12 (8.33%)  1 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Procedural nausea  1  1/12 (8.33%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Investigations         
Visual field tests abnormal  1  0/12 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Muscle spasms  1  0/12 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Nervous system disorders         
Headache  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Psychiatric disorders         
Libido decreased  1  0/12 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Sinus congestion  1  0/12 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Vascular disorders         
Orthostatic hypotension  1  0/12 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (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
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01227252    
Other Study ID Numbers: 13734
I4O-MC-BACB ( Other Identifier: Eli Lilly and Company )
First Submitted: October 21, 2010
First Posted: October 25, 2010
Results First Submitted: May 9, 2019
Results First Posted: July 19, 2019
Last Update Posted: July 19, 2019