A Study of LY3202626 in Healthy Participants and Participants With Alzheimer's Disease
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT02323334
Collaborator
(none)
94
1
17
14
6.7
Study Details
Study Description
Brief Summary
This study involves single and multiple doses of LY3202626 and will evaluate the effects of LY3202626 on the body. There will be 4 parts to this study. In Parts A and B, single increasing doses of LY3202626 will be given in capsule form. Part A will also include itraconazole given orally as a solution. Part A will last approximately 8-12 weeks. Part B will last approximately 5-6 weeks. In Parts C and D, participants will be dosed multiple days with the study drug. Part C will last approximately 11-14 weeks. Part D will last approximately 11-14 weeks and participants must have Alzheimer's Disease. Participants may only enroll in one part.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
94 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
Single- and Multiple-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY3202626
Study Start Date
:
Dec 1, 2014
Actual Primary Completion Date
:
Feb 1, 2016
Actual Study Completion Date
:
Feb 1, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Part A Cohort 1 Sequence1: 0.1mg, 1.6mg, Placcebo; 15mg Part A Cohort 1 involved healthy participants and was comprised of 4 treatment periods with a washout period of approximately 14 days between doses. Period 1: 0.1mg LY3202626 Period 2: 1.6mg LY3202626 Period 3: 15 mg placebo (PBO) Period 4: 15mg LY3202626. |
Drug: LY3202626
administered orally
Drug: Placebo (Part A, B, C)
administered orally
|
| Experimental: Part A Cohort 1 Sequence 2: 0.1mg, PBO, 15mg, 15mg Part A Cohort 1 involved healthy participants and comprised of 4 treatment periods with a washout period of approximately 14 days between doses. Period 1: 0.1mg Period 2: PBO Period 3: 15mg LY3202626 Period 4: 15mg LY3202626. |
Drug: LY3202626
administered orally
Drug: Placebo (Part A, B, C)
administered orally
|
| Experimental: Part A Cohort 1 Sequence 3: PBO, 1.6mg, 15mg, Placebo Part A Cohort 1 involved healthy participants and comprised of 4 treatment periods with a washout period of approximately 14 days between doses. Period 1: PBO Period 2: 1.6mg LY3202626 Period 3: 15mg LY3202626 Period 4: PBO. |
Drug: LY3202626
administered orally
Drug: Placebo (Part A, B, C)
administered orally
|
| Experimental: Part A Cohort 2 Sequence 1:0.4mg, 5mg, PBO, 0.4mg/Itraconazole Part A Cohort 2 involved healthy participants and comprised of 4 treatment periods with a washout period of approximately 14 days between doses. Period 1: 0.4mg LY3202626 Period 2: 5mg LY3202626 Period 3: 45mg, PBO Period 4: 0.4mg LY3202626/200mg Itraconazole. |
Drug: LY3202626
administered orally
Drug: Placebo (Part A, B, C)
administered orally
|
| Experimental: Part A Cohort 2 Sequence 2: 0.4mg, PBO, 45mg. 0.4mg/Itra Part A Cohort 2 involved healthy participants and comprised of 4 treatment periods with a washout period of approximately 14 days between doses. Period 1: 0.4mg LY3202626 Period 2: 5mg, PBO Period 3: 45mg LY3202626 Period 4: 0.4mg LY3202626/200mg Itraconazole. |
Drug: LY3202626
administered orally
Drug: Placebo (Part A, B, C)
administered orally
Drug: Itraconazole
administered orally
|
| Experimental: Part A Cohort 2 Sequence 3:PBO, 5mg, 45mg,0.4mg/200mg Itra Part A Cohort 2 involved healthy participants and was comprised of 4 treatment periods with a washout period of approximately 14 days between doses. Period 1: 0.4mg, PBO Period 2: 5mg LY3202626 Period 3: 45mg LY3202626 Period 4: 0.4mg LY3202626/200mg Itraconazole. |
Drug: LY3202626
administered orally
Drug: Placebo (Part A, B, C)
administered orally
Drug: Itraconazole
administered orally
|
| Experimental: Part A Cohort 3 Sequence 1: Food Effect Fed/Fasted Part A Cohort 3 involved healthy participants and was comprised of two treatment periods with a washout period of approximately 14 days between doses. Single dose of 10mg LY3202626 given PO in Period 1 and 2. Period 1: Fed 2: Fasted. |
Drug: LY3202626
administered orally
|
| Experimental: Part A Cohort 3 Sequence 2: Food Effect Fasted/Fed Part A Cohort 3 involved healthy participants and was comprised of two treatment periods with a washout period of approximately 14 days between doses. Single dose 10mg LY3202626 given PO in Period 1 and 2. Period 1: Fasted 2: Fed. |
Drug: LY3202626
administered orally
|
| Experimental: Part B Cohort 4: 1.6mg Part B Cohort 4 involved healthy participants and was comprised of one period. Single dose of 1.6mg LY3202626 given PO in Period 1. Dose determined by Part A. |
Drug: LY3202626
administered orally
|
| Experimental: Part B Cohort 5: 10mg Part B Cohort 5 involved healthy participants and was comprised of one period. Single dose of 10mg LY3202626 given PO in Period 1. Dose determined by Part A. |
Drug: LY3202626
administered orally
|
| Experimental: Part B Cohort 6: 26mg Part B Cohort 6 involved healthy participants and was comprised of one period. Single dose of 26mg LY3202626 given PO in Period 1. Dose determined by Part A. |
Drug: LY3202626
administered orally
|
| Placebo Comparator: Part B Cohort 4, 5, 6: Placebo Comparator Part B Cohort 4,5,6 involved healthy participants and was comprised of one period. Single dose of PBO given PO in Period 1. |
Drug: Placebo (Part A, B, C)
administered orally
|
| Experimental: Part C Cohort 7: 1mg Part C Cohort 7 involved healthy participants and was comprised of one period. 1mg LY3202626 given PO once daily for 14 days. Dose determined by Part B. |
Drug: LY3202626
administered orally
|
| Experimental: Part C Cohort 8: 6mg Part C Cohort 8 involved healthy participants and was comprised of one period. 6mg LY3202626 was given PO once daily for 14 days. Dose determined by Part B. |
Drug: LY3202626
administered orally
|
| Experimental: Part C Cohort 9: 26mg Part C Cohort 9 included healthy participants and was comprised of one period. 26mg LY3202626 was given PO once daily for 14 days. Dose determined by Part B. |
Drug: LY3202626
administered orally
|
| Placebo Comparator: Part C Cohort 7, 8 ,9: Placebo Comparator Part C Cohort 7,8,9 involved healthy participants and was comprised of one period. Placebo given PO once daily for 14 days. |
Drug: Placebo (Part A, B, C)
administered orally
|
| Experimental: Part D Cohort 10: 6mg Part D Cohort 10 involved participants with Alzheimer's disease and was comprised of one period. 6mg LY3202626 was given PO once daily for 14 days. Dose determined by Part B. |
Drug: LY3202626
administered orally
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [Baseline to Study Completion (up to 14 weeks)]
A summary of other nonserious Adverse Events (AE's), and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Secondary Outcome Measures
- Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3202626 [Part A and B Day 1:Predose, 0.5,1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours postdose; Part C Day 1:Predose, 0.5,1, 2, 4, 6, 8, and 12 hours postdose; Part C Day 14:Predose, 0.5,1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, and 216 hours postdose]
Summary of PK parameters of LY3202626 in plasma following oral administration of single doses for Parts A and B and multiple doses for Part C.
- PK: Area Under the Concentration Time Curve (AUC) of LY3202626 [Part A and B Day 1: Predose, 0.5,1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours postdose; Part C Day 1:Presdose, 0.5,1, 2, 4, 6, 8,12 hours postdose; Day 14: Predose, 0.5,1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, and 216 hours postdose]
Pharmacokinetic parameters for Part A and B were assessed on Day 1 using AUC 0-infinity (AUC0-inf). Pharmacokinetic parameters for Part C were assessed on Day 1 using AUC zero to time to last (AUC0-tlast), Day 14 using AUC steady state.
- Pharmacodynamic(PD) Biomarker: Plasma Minimum Amyloid-Beta Peptide (A-beta) 1-40 Concentration [Part A Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 postdose; Part C Day 14: Predose 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 120, 168, and 216 postdose]
Plasma minimum A-beta 1-40 concentration or nadir concentration (Cnadir) is defined as the lowest concentration of plasma A-beta 1-40 following dose administration.
- PD Biomarker: Cerebral Spinal Fluid (CSF) Minimum Amyloid-beta Peptide (A-beta) 1-40 Concentration [Part B: -4, -2, Predose, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 18, 20, 24, 28, 32, and 36 hours postdose]
CSF minimum A-beta 1-40 concentration or nadir concentration (Cnadir) is defined as the lowest concentration of CSF A-beta 1-40 following dose administration.
- PK: CSF Concentration of LY3202626 [Part C: Day 15 at 24 hours +/- 4 hours (hr) postdose]
- PD Biomarker: Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid-beta Peptide (A-beta) 1-40 Concentration [Parts C: Baseline, Day 15]
CSF Aβ1-40 change from baseline at Day 15 endpoint, 24 hours postdose (+/- 4 hours) following multiple doses of LY3202626.
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
For Parts A, B, and C, are overtly healthy males or females (nonchildbearing potential), as determined by medical history and physical examination
-
Have a body mass index (BMI) of 18 to 32 kilograms per square meter (kg/m^2)
-
For Part D, present with Mild Cognitive Impairment (MCI) due to Alzheimer's Disease (AD) or mild to moderate AD
-
Have venous access sufficient to allow for blood sampling
-
Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures and research unit policies
Exclusion Criteria:
-
Taking over-the-counter or prescription medication with the exception of vitamins or minerals
-
Smoke more than 10 cigarettes per day
-
Are unwilling or unable to refrain from eating any food or drinking any beverage containing grapefruit or grapefruit juice for at least 2 weeks prior to first dose until completion of the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | California Clinical Trials Medical Group | Glendale | California | United States | 91206 |
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:
NCT02323334
Other Study ID Numbers:
- 15562
- I7X-EW-LLCA
First Posted:
Dec 23, 2014
Last Update Posted:
Apr 19, 2021
Last Verified:
Mar 1, 2021
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Part A Cohort 1 Sequence 1: 0.1mg, 1.6mg, Placebo (PBO); 15mg | Part A Cohort 1 Sequence 2: 1.6mg, PBO,15mg, 15mg | Part A Cohort 1 Sequence 3: PBO, 1.6mg, 15mg, PBO | Part A Cohort 2 Sequence 1:0.4mg, 5mg, PBO; 0.4mg/200mg Itra | Part A Cohort 2 Sequence 2: 0.4mg, PBO, 45mg. 0.4mg/200mg Itra | Part A Cohort 2 Sequence 3:PBO, 5mg, 45mg,0.4mg/200mg Itra | Part A Cohort 3 Sequence 1: Food Effect Fed/Fasted | Part A Cohort 3 Sequence 2: Food Effect Fasted/Fed | Part B Cohort 4: 1.6mg | Part B Cohort 5: 10mg | Part B Cohort 6: 26mg | Part B Cohort 4, 5, 6: PBO Comparator | Part C Cohort 7: 1mg | Part C Cohort 8: 6mg | Part C Cohort 9: 26mg | Part C Cohort 7, 8 ,9: PBO Comparator | Part D Cohort 10: 6mg |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Part A Cohort 1 involved healthy participants and was comprised of 4 treatment periods. There was a washout period of approximately 14 days between doses. Period 1: 0.1mg LY3202626 Period 2: 1.6mg LY3202626 Period 3: 15 mg PBO Period 4: 15mg LY3202626 | Part A Cohort 1 involved healthy participants and was comprised of 4 treatment periods. There was a washout period of approximately 14 days between doses. Period 1: 1.6mg LY3202626 Period 2: PBO Period 3: 15mg LY3202626 Period 4: 15mg LY3202626 | Part A Cohort 1 involved healthy participants and was comprised of 4 treatment periods. There was a washout period of approximately 14 days between doses. Period 1: PBO Period 2: 1.6mg LY3202626 Period 3: 15mg LY3202626 Period 4: PBO | Part A Cohort 2 involved healthy participants and was comprised of 4 treatment periods. Period 4 includes 0.4mg LY3202626 and 200mg Itraconazole (Itra). There was a washout period of approximately 14 days between doses. Period 1: 0.4mg LY3202626 Period 2: 5mg LY3202626 Period 3: 45mg PBO Period 4: 0.4mg LY3202626/200mg Itraconazole | Part A Cohort 2 involved healthy participants and was comprised of 4 treatment periods. Period 4 includes 0.4mg LY3202626 and 200mg Itraconazole.There was a washout period of approximately 14 days between doses. Period 1: 0.4mg LY3202626 Period 2: 5mg PBO Period 3: 45mg LY3202626 Period 4: 0.4mg LY3202626/200mg Itraconazole | Part A Cohort 2 involved healthy participants and was comprised of 4 treatment periods. Period 4 includes 0.4mg LY3202626 and 200mg Itraconazole. There was a washout period of approximately 14 days between doses. Period 1: 0.4mg PBO Period 2: 5mg LY3202626 Period 3: 45mg LY3202626 Period 4: 0.4mg LY3202626/200mg Itraconazole | Part A Cohort 3 involved healthy participants and was comprised of two treatment periods. Single dose of 10mg LY3202626 given PO in Period 1 and 2. There was a washout period of approximately 14 days between doses. Period 1: Fed Period 2: Fasted | Part A Cohort 3 involved healthy participants and was comprised of two treatment periods. Single dose 10mg LY3202626 given PO in Period 1 and 2. There was a washout period of approximately 14 days between doses. Period 1: Fasted Period 2: Fed | Part B Cohort 4 involved healthy participants and was comprised of one period. Single dose of 1.6mg LY3202626 given PO in Period 1. Dose determined by Part A. | Part B Cohort 5 involved healthy participants and was comprised of one period. Single dose of 10mg LY3202626 given PO in Period 1. Dose determined by Part A. | Part B Cohort 6 involved healthy participants and was comprised of one period. Single dose of 26mg LY3202626 given PO in Period 1. Dose determined by Part A. | Part B Cohort 4,5,6 involved healthy participants and was comprised of one period. Single dose of PBO given PO in Period 1. | Part C Cohort 7 involved healthy participants and was comprised of one period. 1mg LY3202626 given PO once daily for 14 days. Dose determined by Part B. | Part C Cohort 8 involved healthy participants and was comprised of one period. 6mg LY3202626 was given PO once daily for 14 days. Dose determined by Part B. | Part C Cohort 9 included healthy participants and was comprised of one period. 26mg LY3202626 was given PO once daily for 14 days. Dose determined by Part B. | Part C Cohort 7, 8, 9 involved healthy participants and was comprised of one period. PBO given PO once daily for 14 days. | Part D Cohort 10 involved participants with Alzheimer's disease and was comprised of one period. 6mg LY3202626 was given PO once daily for 14 days. Dose determined by Part B. |
| Period Title: Period 1 | |||||||||||||||||
| STARTED | 4 | 4 | 4 | 4 | 4 | 4 | 6 | 6 | 5 | 7 | 5 | 3 | 9 | 9 | 9 | 9 | 2 |
| Received at Least One Dose of Study Drug | 4 | 4 | 4 | 4 | 4 | 4 | 6 | 6 | 5 | 7 | 5 | 3 | 9 | 9 | 9 | 9 | 2 |
| COMPLETED | 4 | 4 | 4 | 4 | 4 | 4 | 6 | 6 | 5 | 7 | 5 | 3 | 9 | 9 | 9 | 9 | 2 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Period Title: Period 1 | |||||||||||||||||
| STARTED | 4 | 4 | 4 | 4 | 4 | 4 | 6 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| COMPLETED | 4 | 4 | 4 | 4 | 4 | 4 | 6 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Period Title: Period 1 | |||||||||||||||||
| STARTED | 4 | 4 | 4 | 4 | 4 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| COMPLETED | 3 | 4 | 3 | 4 | 4 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Period Title: Period 1 | |||||||||||||||||
| STARTED | 3 | 4 | 3 | 4 | 4 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| COMPLETED | 3 | 4 | 3 | 4 | 4 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Part A Cohort 1 | Part A Cohort 2 | Part A Food Effect Cohort 3 | Part B Cohort 4 | Part B Cohort 5 | Part B Cohort 6 | Part C Cohort 7 | Part C Cohort 8 | Part C Cohort 9 | Part D Cohort 10 | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Escalating single dose given orally (PO)per randomly assigned treatment sequence of 0.1mg, 1.6mg, 15mg LY3202626 or placebo. | Escalating single dose given PO per randomly assigned treatment sequence of 0.4mg, 5mg, or 45mg LY3202626, placebo. Some participants may also receive multiple doses of 200 mg of Itraconazole PO in 1 period with 0.4mg of LY3202626. | Single dose of 10mg LY3202626 given PO in Period 1 and Period 2 only. | Single oral dose of 1.6mg LY3202626 or placebo given PO in Period 1. Dose determined by Part A. | Single oral dose of 10mg LY3202626 or placebo given PO in in Period 1. Dose determined by Part A. | Single oral dose of 26mg LY3202626 or placebo given PO in Period 1. Dose determined by Part A. | Multiple oral doses of 1mg LY3202626 given PO once daily for 14 days. Dose determined by Part B. | Multiple oral doses of 6mg LY3202626 given PO once daily for 14 days. Dose determined by Part B. | Multiple oral doses of 26mg LY3202626 given PO once daily for 14 days. Dose determined by Part B. | Multiple oral doses of 6mg LY3202626 given PO once daily for 14 days. Dose determined by Part B. | Total of all reporting groups |
| Overall Participants | 12 | 12 | 12 | 6 | 8 | 6 | 12 | 12 | 12 | 2 | 94 |
| Age (years) [Mean (Standard Deviation) ] | |||||||||||
| Mean (Standard Deviation) [years] |
33.0
(8.1)
|
36.9
(8.4)
|
39.0
(13.6)
|
36.5
(12.4)
|
43.0
(11.3)
|
35.2
(7.2)
|
37.5
(10.5)
|
40.4
(8.1)
|
40.5
(10.5)
|
68.0
(2.8)
|
38.70
(10.93)
|
| Sex: Female, Male (Count of Participants) | |||||||||||
| Female |
1
8.3%
|
1
8.3%
|
4
33.3%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
8.3%
|
1
8.3%
|
2
100%
|
10
10.6%
|
| Male |
11
91.7%
|
11
91.7%
|
8
66.7%
|
6
100%
|
8
100%
|
6
100%
|
12
100%
|
11
91.7%
|
11
91.7%
|
0
0%
|
84
89.4%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||||||||
| Hispanic or Latino |
2
16.7%
|
1
8.3%
|
3
25%
|
0
0%
|
1
12.5%
|
3
50%
|
2
16.7%
|
3
25%
|
3
25%
|
0
0%
|
18
19.1%
|
| Not Hispanic or Latino |
10
83.3%
|
11
91.7%
|
9
75%
|
6
100%
|
7
87.5%
|
3
50%
|
10
83.3%
|
9
75%
|
9
75%
|
2
100%
|
76
80.9%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
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%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
6
50%
|
6
50%
|
4
33.3%
|
0
0%
|
0
0%
|
0
0%
|
4
33.3%
|
4
33.3%
|
4
33.3%
|
2
100%
|
30
31.9%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
2
16.7%
|
2
16.7%
|
3
25%
|
2
33.3%
|
1
12.5%
|
1
16.7%
|
3
25%
|
3
25%
|
1
8.3%
|
0
0%
|
18
19.1%
|
| White |
3
25%
|
4
33.3%
|
5
41.7%
|
4
66.7%
|
7
87.5%
|
5
83.3%
|
4
33.3%
|
5
41.7%
|
7
58.3%
|
0
0%
|
44
46.8%
|
| More than one race |
1
8.3%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
8.3%
|
0
0%
|
0
0%
|
0
0%
|
2
2.1%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||||||||||
| United States |
12
100%
|
12
100%
|
12
100%
|
6
100%
|
8
100%
|
6
100%
|
12
100%
|
12
100%
|
12
100%
|
2
100%
|
94
100%
|
Outcome Measures
| Title | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration |
|---|---|
| Description | A summary of other nonserious Adverse Events (AE's), and all SAE's, regardless of causality, is located in the Reported Adverse Events section. |
| Time Frame | Baseline to Study Completion (up to 14 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least one dose of study drug. |
| Arm/Group Title | Part A, B, and C Placebo (PBO) | Part A 0.1mg LY3202626 | Part A 0.4mg LY3202626 | Part A 0.4mg LY3202626 + 200mg Itraconazole | Part C 1mg LY3202626 QD | Part A and B 1.6mg LY3202626 | Part A 5mg LY3202626 | Part C and D 6mg LY3202626 QD | Part A, B and C 10mg LY3202626 | Part A 15mg LY3202626 | Part B and C 26mg LY3202626 | Part A 45mg LY3202626 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Single dose placebo given PO in Part A and B. Multiple doses of PBO given PO in Part C. | Single dose of 0.1mg LY3202626 given PO Period 1 Cohort 1. | Single dose of 0.4mg LY3202626 given PO in Period 1 Cohort 2. | Single dose of 0.4mg LY3202626 +200mg Itraconazole given PO in Period 4 Cohort 2. | Multiple daily dose of 1mg LY3202626 given PO once daily for 14 days. | Single dose of 1.6mg LY3202626 given PO in Period 2 Cohort 1 in Part A and Period 1 Part B. | Single dose of 5mg LY3202626 given PO in in Period 2 Cohort 2. | Multiple daily dose of 6mg LY3202626 given PO once daily for 14 days. | Single dose of 10mg LY3202626 given PO in Part A and B. Multiple dose of 10mg LY3202626 given PO in Part C once daily for 14 days. | Single dose of 15mg LY3202626 given PO in Period 3 Cohort 1. | Single dose of 26mg LY3202626 given PO in Period 1 in Part B. Multiple daily dose of 26mg LY3202626 given PO once daily for 14 days in Part C. | Single dose of 45mg LY3202626 given PO in in Period 3 Cohort 2. |
| Measure Participants | 36 | 8 | 8 | 12 | 9 | 13 | 8 | 11 | 19 | 11 | 14 | 8 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
| Title | Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3202626 |
|---|---|
| Description | Summary of PK parameters of LY3202626 in plasma following oral administration of single doses for Parts A and B and multiple doses for Part C. |
| Time Frame | Part A and B Day 1:Predose, 0.5,1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours postdose; Part C Day 1:Predose, 0.5,1, 2, 4, 6, 8, and 12 hours postdose; Part C Day 14:Predose, 0.5,1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, and 216 hours postdose |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants in Part A, B, and C who received at least one dose of study drug and had evaluable PK data. |
| Arm/Group Title | Part A 0.1mg LY3202626 | Part A 0.4mg LY3202626 | Part A 1.6mg LY3202626 | Part A 5mg LY3202626 | Part A 15mg LY3202626 | Part A 45mg LY3202626 | Part B 1.6mg LY3202626 | Part B 10mg LY3202626 | Part B 26mg LY3202626 | Part C 1mg LY3202626 QD | Part C 6mg LY3202626 QD | Part C 26mg LY3202626 QD |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Single dose of 0.1mg LY3202626 given PO in Period 1 Cohort 1. | Single dose of 0.4mg LY3202626 given PO in Period 1 Cohort 2. | Single dose of 1.6mg LY3202626 given PO in Period 2 Cohort 1. | Single dose of 5mg LY3202626 given PO in Period 2 Cohort 2. | Single dose of 15mg LY3202626 given PO in Period 3 Cohort 1. | Single dose of 45mg LY3202626 given PO in Period 3 Cohort 2. | Single dose of 1.6mg LY3202626 given PO Period 1. | Single dose of 10mg LY3202626 given PO in Period 1. | Single dose of 26mg LY3202626 given PO in Period1. | Multiple doses of 1mg LY3202626 given PO once daily for 14 days. | Multiple doses of 6mg LY3202626 given PO once daily for 14 days. | Multiple doses of 26mg LY3202626 given PO once daily for 14 days. |
| Measure Participants | 3 | 8 | 8 | 8 | 8 | 8 | 5 | 7 | 5 | 8 | 9 | 9 |
| Geometric Mean (Geometric Coefficient of Variation) [nanograms per milliliter (ng/mL)] |
0.169
(50)
|
0.486
(81)
|
2.89
(70)
|
7.91
(56)
|
21.3
(77)
|
92.5
(47)
|
2.90
(86)
|
3.75
(176)
|
36.1
(126)
|
2.57
(2.5)
|
11.2
(71)
|
72.8
(61)
|
| Title | PK: Area Under the Concentration Time Curve (AUC) of LY3202626 |
|---|---|
| Description | Pharmacokinetic parameters for Part A and B were assessed on Day 1 using AUC 0-infinity (AUC0-inf). Pharmacokinetic parameters for Part C were assessed on Day 1 using AUC zero to time to last (AUC0-tlast), Day 14 using AUC steady state. |
| Time Frame | Part A and B Day 1: Predose, 0.5,1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours postdose; Part C Day 1:Presdose, 0.5,1, 2, 4, 6, 8,12 hours postdose; Day 14: Predose, 0.5,1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, and 216 hours postdose |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants in Parts A, B, and C who received at least one dose of study drug and had evaluable PK data. |
| Arm/Group Title | Part A 0.1mg LY3202626 | Part A 0.4mg LY3202626 | Part A 1.6mg LY3202626 | Part A 5mg LY3202626 | Part A 15mg LY3202626 | Part A 45mg LY3202626 | Part B 1.6mg LY3202626 | Part B 10mg LY3202626 | Part B 26mg LY3202626 | Part C 1mg LY3202626 QD | Part C 6mg LY3202626 QD | Part C 26mg LY3202626 QD |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Single dose of 0.1mg LY3202626 given PO in Period 1 Cohort 1. | Single dose of 0.4mg LY3202626 given PO in Period 1 Cohort 2. | Single dose of 1.6mg LY3202626 given PO in Period 2 Cohort 1. | Single dose of 5mg LY3202626 given PO in Period 2 Cohort 2. | Single dose of 15mg LY3202626 given PO in Period 3 Cohort 1. | Single dose of 45mg LY3202626 given PO in Period 3 Cohort 2. | Single dose of 1.6mg LY3202626 given PO in Period 1. | Single dose of 10mg LY3202626 given PO in Period 1. | Single dose of 26mg LY3202626 given PO in Period 1. | Multiple doses of 1mg LY3202626 given PO once daily for 14 days.. | Multiple doses of 6mg LY3202626 given PO once daily for 14 days. | Multiple doses of 26mg LY3202626 given PO once daily for 14 days. |
| Measure Participants | 3 | 8 | 8 | 8 | 8 | 8 | 5 | 7 | 5 | 8 | 9 | 9 |
| Geometric Mean (Geometric Coefficient of Variation) [nanogram x hour/milliliter (ng*hr/mL)] |
NA
(NA)
|
NA
(NA)
|
60.6
(49)
|
197
(38)
|
393
(84)
|
1680
(34)
|
49.9
(41)
|
102
(111)
|
575
(62)
|
38.6
(25)
|
151
(54)
|
1020
(50)
|
| Title | Pharmacodynamic(PD) Biomarker: Plasma Minimum Amyloid-Beta Peptide (A-beta) 1-40 Concentration |
|---|---|
| Description | Plasma minimum A-beta 1-40 concentration or nadir concentration (Cnadir) is defined as the lowest concentration of plasma A-beta 1-40 following dose administration. |
| Time Frame | Part A Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 postdose; Part C Day 14: Predose 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 120, 168, and 216 postdose |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants in Part A, Periods 1-3 and Part C, Period 3, who received at least one dose of study drug and had evaluable PD data analyzed per protocol. Participants in Part B and D were not assessed per protocol. |
| Arm/Group Title | Part A Placebo | Part A 0.1mg LY3202626 | Part A 0.4mg LY3202626 | Part A 1.6 mg LY3202626 | Part A 5mg LY3202626 | Part A 15mg LY3202626 | Part A 45mg LY3202626 | Part C Placebo | Part C 1mg LY3202626 QD | Part C 6mg LY3202626 QD | Part C 26mg LY3202626 QD |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Single dose of placebo given PO in capsule form in Period 1-4. | Single dose 0.1mg LY3202626 given PO in Period 1 Cohort 1. | Single dose of 0.4mg LY3202626 given PO in Period 1 Cohort 2. | Single dose of 1.6mg LY3202626 given PO in Period 2 Cohort 1. | Single dose of 5mg LY3202626 given PO in Period 2 Cohort 2. | Single dose of 15mg LY3202626 given PO in Period 3 and Period 4 Cohort 1. | Single dose of 45mg LY3202626 given PO in Period 3 Cohort 2. | Multiple doses of placebo given PO once daily for 14 days. | Multiple doses of 1mg LY3202626 in given PO once daily for 14 days. | Multiple doses of 6mg LY3202626 given PO once daily for 14 days. | Multiple doses of 26mg LY3202626 given PO once daily for 14 days. |
| Measure Participants | 24 | 8 | 8 | 8 | 8 | 8 | 8 | 9 | 9 | 9 | 9 |
| Geometric Mean (Geometric Coefficient of Variation) [Picogram per milliliter (pg/mL)] |
107
(35.1)
|
58.1
(150)
|
61.8
(25.6)
|
33.4
(62.0)
|
25.2
(16.8)
|
17.0
(33.6)
|
7.93
(42.0)
|
84.6
(26.5)
|
24.0
(33.1)
|
5.80
(51.9)
|
4.2
(0)
|
| Title | PD Biomarker: Cerebral Spinal Fluid (CSF) Minimum Amyloid-beta Peptide (A-beta) 1-40 Concentration |
|---|---|
| Description | CSF minimum A-beta 1-40 concentration or nadir concentration (Cnadir) is defined as the lowest concentration of CSF A-beta 1-40 following dose administration. |
| Time Frame | Part B: -4, -2, Predose, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 18, 20, 24, 28, 32, and 36 hours postdose |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants in Part B who received at least one dose of study drug and had evaluable CSF PD data analyzed per protocol. Participants in Part A, C and D were not assessed per protocol. |
| Arm/Group Title | Part B Placebo | Part B 1.6 mg LY3202626 | Part B 6mg LY3202626 | Part B 26mg LY3202626 |
|---|---|---|---|---|
| Arm/Group Description | Single dose of placebo given PO in Period 1. | Single dose of 1.6mg LY3202626 given PO in Period 1. | Single dose of 6mg LY3202626 given PO in Period 1. | Single dose of 26mg LY3202626 given PO in Period 1. |
| Measure Participants | 3 | 5 | 5 | 5 |
| Geometric Mean (Geometric Coefficient of Variation) [pg/mL] |
7980
(53.8)
|
5700
(22.3)
|
5770
(41.8)
|
2980
(46.4)
|
| Title | PK: CSF Concentration of LY3202626 |
|---|---|
| Description | |
| Time Frame | Part C: Day 15 at 24 hours +/- 4 hours (hr) postdose |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants in Part C who received at least one dose of study drug and had evaluable CSF PK data per protocol. Participants in Part A, B and D were not assessed per protocol. |
| Arm/Group Title | Part C 1mg LY3202626 | Part C 6 mg LY3202626 | Part C 26mg LY3202626 |
|---|---|---|---|
| Arm/Group Description | Multiple doses of 1mg LY3202626 given PO once daily for 14 days. | Multiple doses of 6mg LY3202626 given PO once daily for 14 days. | Multiple doses of 26mg LY3202626 given PO once daily for 14 days. |
| Measure Participants | 9 | 9 | 9 |
| Geometric Mean (Geometric Coefficient of Variation) [ng/mL] |
0.0648
(46.2)
|
0.202
(48.9)
|
1.26
(44.8)
|
| Title | PD Biomarker: Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid-beta Peptide (A-beta) 1-40 Concentration |
|---|---|
| Description | CSF Aβ1-40 change from baseline at Day 15 endpoint, 24 hours postdose (+/- 4 hours) following multiple doses of LY3202626. |
| Time Frame | Parts C: Baseline, Day 15 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants in Part C who received at least one dose of study drug and had evaluable CSF PD data analyzed. Participants in Part A, B and D were not assessed per protocol. |
| Arm/Group Title | Part C Placebo | Part C 1mg LY3202626 | Part C 6mg LY3202626 | Part C 26mg LY3202626 |
|---|---|---|---|---|
| Arm/Group Description | Multiple doses of placebo given PO once daily for 14 days. | Multiple doses of 1mg LY3202626 given PO once daily for 14 days. | Multiple doses of 6mg LY3202626 given PO once daily for 14 days. | Multiple doses of 26mg LY3202626 given PO once daily for 14 days. |
| Measure Participants | 9 | 9 | 9 | 9 |
| Mean (Standard Deviation) [percent change in concentration] |
-21.3
(16.8)
|
-50.1
(8.56)
|
-75.7
(7.38)
|
-93.7
(2.39)
|
Adverse Events
| Time Frame | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||||||||||||||
| Arm/Group Title | Part A, B, and C Placebo | Part A 0.1mg LY3202626 | Part A 0.4mg LY3202626 | Part A 0.4mg LY3202626 + 200mg Itraconazole | Part C 1mg LY3202626 QD | Part A and B 1.6mg LY3202626 | Part A 5mg LY3202626 | Part C and Part D 6mg LY3202626 QD | Part A and B 10mg LY3202626 | Part A 15mg LY3202626 | Part B and C 26mg LY3202626 | Part A 45mg LY3202626 | ||||||||||||
| Arm/Group Description | Single dose of placebo given PO in in capsule form, Part A and B. Multiple doses of placebo given PO in capsule form, Part C. | Single dose of 0.1mg LY3202626 given PO in in capsule form. | Single dose of 0.4mg LY3202626 given PO in in capsule form. | Single dose of 0.4mg LY3202626 +200mg Itraconazole given PO in in capsule form. | Multiple daily dose of 1mg LY3202626 given PO in in capsule form. | Single dose of 1.6mg LY3202626 given PO in in capsule form.. | Single dose of 5mg LY3202626 given PO in in capsule form. | Multiple daily dose of 6mg LY3202626 given PO in capsule form. | Single dose of 10mg LY3202626 given PO in capsule form. | Single dose of 15mg LY3202626 given PO in capsule form. | Single dose of 26mg LY3202626 given PO in capsule form, Part B. Multiple daily dose of 26mg LY3202626 in in capsule form, Part C. | Single dose of 45mg LY3202626 given PO in in capsule form. | ||||||||||||
All Cause Mortality |
||||||||||||||||||||||||
| Part A, B, and C Placebo | Part A 0.1mg LY3202626 | Part A 0.4mg LY3202626 | Part A 0.4mg LY3202626 + 200mg Itraconazole | Part C 1mg LY3202626 QD | Part A and B 1.6mg LY3202626 | Part A 5mg LY3202626 | Part C and Part D 6mg LY3202626 QD | Part A and B 10mg LY3202626 | Part A 15mg LY3202626 | Part B and C 26mg LY3202626 | Part A 45mg LY3202626 | |||||||||||||
| 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 | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||||||||
Serious Adverse Events |
||||||||||||||||||||||||
| Part A, B, and C Placebo | Part A 0.1mg LY3202626 | Part A 0.4mg LY3202626 | Part A 0.4mg LY3202626 + 200mg Itraconazole | Part C 1mg LY3202626 QD | Part A and B 1.6mg LY3202626 | Part A 5mg LY3202626 | Part C and Part D 6mg LY3202626 QD | Part A and B 10mg LY3202626 | Part A 15mg LY3202626 | Part B and C 26mg LY3202626 | Part A 45mg LY3202626 | |||||||||||||
| 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 | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/36 (0%) | 0/8 (0%) | 0/8 (0%) | 0/12 (0%) | 0/9 (0%) | 0/13 (0%) | 0/8 (0%) | 0/11 (0%) | 0/19 (0%) | 0/11 (0%) | 0/14 (0%) | 0/8 (0%) | ||||||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||||||||||
| Part A, B, and C Placebo | Part A 0.1mg LY3202626 | Part A 0.4mg LY3202626 | Part A 0.4mg LY3202626 + 200mg Itraconazole | Part C 1mg LY3202626 QD | Part A and B 1.6mg LY3202626 | Part A 5mg LY3202626 | Part C and Part D 6mg LY3202626 QD | Part A and B 10mg LY3202626 | Part A 15mg LY3202626 | Part B and C 26mg LY3202626 | Part A 45mg LY3202626 | |||||||||||||
| 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 | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 10/36 (27.8%) | 0/8 (0%) | 1/8 (12.5%) | 7/12 (58.3%) | 4/9 (44.4%) | 4/13 (30.8%) | 3/8 (37.5%) | 6/11 (54.5%) | 7/19 (36.8%) | 2/11 (18.2%) | 13/14 (92.9%) | 1/8 (12.5%) | ||||||||||||
| Cardiac disorders | ||||||||||||||||||||||||
| Postural orthostatic tachycardia syndrome | 0/36 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/19 (0%) | 0 | 0/11 (0%) | 0 | 1/14 (7.1%) | 1 | 0/8 (0%) | 0 |
| Eye disorders | ||||||||||||||||||||||||
| Dry eye | 0/36 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 1/19 (5.3%) | 1 | 0/11 (0%) | 0 | 0/14 (0%) | 0 | 0/8 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||||||||||||||
| Abdominal pain | 0/36 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 1/13 (7.7%) | 1 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/19 (0%) | 0 | 0/11 (0%) | 0 | 0/14 (0%) | 0 | 0/8 (0%) | 0 |
| Constipation | 0/36 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 | 0/19 (0%) | 0 | 0/11 (0%) | 0 | 0/14 (0%) | 0 | 0/8 (0%) | 0 |
| Diarrhoea | 0/36 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 3/12 (25%) | 3 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/19 (0%) | 0 | 0/11 (0%) | 0 | 0/14 (0%) | 0 | 0/8 (0%) | 0 |
| Faeces discoloured | 7/36 (19.4%) | 7 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 1/8 (12.5%) | 1 | 2/11 (18.2%) | 2 | 0/19 (0%) | 0 | 0/11 (0%) | 0 | 9/14 (64.3%) | 9 | 0/8 (0%) | 0 |
| Nausea | 0/36 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/19 (0%) | 0 | 1/11 (9.1%) | 1 | 1/14 (7.1%) | 1 | 0/8 (0%) | 0 |
| Vomiting | 0/36 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/12 (8.3%) | 2 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/19 (0%) | 0 | 0/11 (0%) | 0 | 0/14 (0%) | 0 | 0/8 (0%) | 0 |
| General disorders | ||||||||||||||||||||||||
| Chest pain | 0/36 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/19 (0%) | 0 | 0/11 (0%) | 0 | 0/14 (0%) | 0 | 1/8 (12.5%) | 1 |
| Chills | 0/36 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 1/19 (5.3%) | 1 | 0/11 (0%) | 0 | 0/14 (0%) | 0 | 0/8 (0%) | 0 |
| Cyst | 0/36 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/19 (0%) | 0 | 0/11 (0%) | 0 | 0/14 (0%) | 0 | 0/8 (0%) | 0 |
| Fatigue | 0/36 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 1/19 (5.3%) | 1 | 0/11 (0%) | 0 | 0/14 (0%) | 0 | 0/8 (0%) | 0 |
| Non-cardiac chest pain | 0/36 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/12 (8.3%) | 1 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/19 (0%) | 0 | 0/11 (0%) | 0 | 0/14 (0%) | 0 | 0/8 (0%) | 0 |
| Pain | 0/36 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 1/19 (5.3%) | 1 | 0/11 (0%) | 0 | 0/14 (0%) | 0 | 0/8 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||||||||||||||||
| Post lumbar puncture syndrome | 2/36 (5.6%) | 4 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/12 (0%) | 0 | 2/9 (22.2%) | 3 | 3/13 (23.1%) | 8 | 0/8 (0%) | 0 | 2/11 (18.2%) | 2 | 5/19 (26.3%) | 12 | 0/11 (0%) | 0 | 5/14 (35.7%) | 8 | 0/8 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||||||||||||||||||
| Decreased appetite | 0/36 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 1/8 (12.5%) | 1 | 0/11 (0%) | 0 | 1/19 (5.3%) | 1 | 0/11 (0%) | 0 | 1/14 (7.1%) | 1 | 0/8 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||||||||
| Arthralgia | 0/36 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 1/13 (7.7%) | 2 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 1/19 (5.3%) | 1 | 0/11 (0%) | 0 | 0/14 (0%) | 0 | 0/8 (0%) | 0 |
| Nervous system disorders | ||||||||||||||||||||||||
| Burning sensation | 0/36 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 0/13 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/19 (0%) | 0 | 0/11 (0%) | 0 | 0/14 (0%) | 0 | 0/8 (0%) | 0 |
| Dizziness | 0/36 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 2/12 (16.7%) | 2 | 0/9 (0%) | 0 | 1/13 (7.7%) | 1 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 1/19 (5.3%) | 1 | 1/11 (9.1%) | 1 | 2/14 (14.3%) | 2 | 0/8 (0%) | 0 |
| Dysgeusia | 1/36 (2.8%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 0/13 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/19 (0%) | 0 | 0/11 (0%) | 0 | 0/14 (0%) | 0 | 0/8 (0%) | 0 |
| Headache | 1/36 (2.8%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 2/12 (16.7%) | 2 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 1/8 (12.5%) | 1 | 1/11 (9.1%) | 1 | 3/19 (15.8%) | 5 | 0/11 (0%) | 0 | 0/14 (0%) | 0 | 0/8 (0%) | 0 |
| Memory impairment | 0/36 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/19 (0%) | 0 | 0/11 (0%) | 0 | 1/14 (7.1%) | 1 | 0/8 (0%) | 0 |
| Somnolence | 0/36 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 2/12 (16.7%) | 2 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/19 (0%) | 0 | 0/11 (0%) | 0 | 0/14 (0%) | 0 | 0/8 (0%) | 0 |
| Psychiatric disorders | ||||||||||||||||||||||||
| Abnormal dreams | 0/36 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 0/13 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/19 (0%) | 0 | 0/11 (0%) | 0 | 0/14 (0%) | 0 | 0/8 (0%) | 0 |
| Nightmare | 0/36 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/12 (0%) | 0 | 1/9 (11.1%) | 1 | 0/13 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/19 (0%) | 0 | 0/11 (0%) | 0 | 0/14 (0%) | 0 | 0/8 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||||||
| Oropharyngeal pain | 0/36 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/19 (0%) | 0 | 1/11 (9.1%) | 1 | 0/14 (0%) | 0 | 0/8 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||||||||||||||||||
| Rash erythematous | 0/36 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 0/8 (0%) | 0 | 1/11 (9.1%) | 1 | 0/19 (0%) | 0 | 0/11 (0%) | 0 | 0/14 (0%) | 0 | 0/8 (0%) | 0 |
| Vascular disorders | ||||||||||||||||||||||||
| Hot flush | 0/36 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 1/13 (7.7%) | 1 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 0/19 (0%) | 0 | 0/11 (0%) | 0 | 0/14 (0%) | 0 | 0/8 (0%) | 0 |
| Orthostatic hypotension | 0/36 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/12 (0%) | 0 | 0/9 (0%) | 0 | 0/13 (0%) | 0 | 0/8 (0%) | 0 | 0/11 (0%) | 0 | 1/19 (5.3%) | 1 | 0/11 (0%) | 0 | 0/14 (0%) | 0 | 0/8 (0%) | 0 |
Limitations/Caveats
[Not Specified]
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.
Results Point of Contact
| Name/Title | Chief Medical Officer |
|---|---|
| Organization | Eli Lilly and Company |
| Phone | 800-545-5979 |
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT02323334
Other Study ID Numbers:
- 15562
- I7X-EW-LLCA
First Posted:
Dec 23, 2014
Last Update Posted:
Apr 19, 2021
Last Verified:
Mar 1, 2021