Trial Outcomes & Findings for A Study of Lanabecestat (LY3314814) in Healthy Participants (NCT NCT02663128)
NCT ID: NCT02663128
Last Updated: 2019-11-01
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
Day 1 of Periods 1, 2, and 3: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56, 72, 96, and 120 hours post-dose
Results posted on
2019-11-01
Participant Flow
To obtain representative age-related data, attempts were made to enroll at least 6 participants who were \>55 years of age.
Participants were randomized to 1 of 6 treatment sequences over 3 treatment periods that were 7 days long with a 7-day washout period between doses. Participants were either in a fasted state or fed state. Sequences contain a Reference (Fasted) dose; Test (Fasted) dose, and Test (Fed) dose: R (Fast)/ T (Fast)/ T (Fed), respectively.
Participant milestones
| Measure |
Sequence 1
LY3314814 (AZD3293): 50 milligram (mg) administered once orally (PO) in each of 3 treatment periods. Treatment sequence: Reference (R \[Fasted\])/ Test (T \[Fasted\])/ T (Fed)
|
Sequence 2
LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Treatment sequence: T (Fasted)/T (Fed)/ R (Fasted)
|
Sequence 3
LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Treatment sequence:T (Fed)/ R (Fasted)/ T (Fasted)
|
Sequence 4
LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Treatment sequence:T(Fed)/ T (Fasted)/ R (Fasted)
|
Sequence 5
LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Treatment sequence: R (Fasted)/T (Fed)/ T (Fasted)
|
Sequence 6
LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Treatment sequence:T (Fasted)/ R (Fasted)/ T (Fed)
|
|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Period 1
Received at Least One Dose of Study Drug
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Period 1
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Period 2
COMPLETED
|
3
|
3
|
3
|
3
|
2
|
3
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Period 3
STARTED
|
3
|
3
|
3
|
3
|
2
|
3
|
|
Period 3
COMPLETED
|
3
|
3
|
3
|
3
|
2
|
3
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1
LY3314814 (AZD3293): 50 milligram (mg) administered once orally (PO) in each of 3 treatment periods. Treatment sequence: Reference (R \[Fasted\])/ Test (T \[Fasted\])/ T (Fed)
|
Sequence 2
LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Treatment sequence: T (Fasted)/T (Fed)/ R (Fasted)
|
Sequence 3
LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Treatment sequence:T (Fed)/ R (Fasted)/ T (Fasted)
|
Sequence 4
LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Treatment sequence:T(Fed)/ T (Fasted)/ R (Fasted)
|
Sequence 5
LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Treatment sequence: R (Fasted)/T (Fed)/ T (Fasted)
|
Sequence 6
LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Treatment sequence:T (Fasted)/ R (Fasted)/ T (Fed)
|
|---|---|---|---|---|---|---|
|
Period 2
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of Lanabecestat (LY3314814) in Healthy Participants
Baseline characteristics by cohort
| Measure |
18 to 55 Years
n=8 Participants
LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Reference formulation for fasted group Test formulation for fasted and non-fasted group
|
> 55 Years
n=10 Participants
LY3314814 (AZD3293): 50 mg administered once orally PO in each of 3 treatment periods. Reference formulation for fasted group Test formulation for fasted and non-fasted group
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.3 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
61.4 years
STANDARD_DEVIATION 5.6 • n=7 Participants
|
51.6 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 of Periods 1, 2, and 3: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56, 72, 96, and 120 hours post-dosePopulation: All participants who received at least one dose of study drug and had evaluable PK data.
Outcome measures
| Measure |
R (Fasted)
n=18 Participants
LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Reference formulation for fasted group
|
T (Fasted)
n=17 Participants
LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Test formulation for fasted group.
|
T (Fed)
n=18 Participants
LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Test formulation for non-fasted group
|
|---|---|---|---|
|
Pharmacokinetics(PK): Maximum Concentration (Cmax) of LY3314814 (AZD3293)
18 to 55 Years
|
194 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 22
|
212 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 22
|
164 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 21
|
|
Pharmacokinetics(PK): Maximum Concentration (Cmax) of LY3314814 (AZD3293)
> 55 Years
|
208 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 31
|
196 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 36
|
168 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 32
|
PRIMARY outcome
Timeframe: Day 1 of Periods 1, 2, and 3:Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56, 72, 96, and 120 hours post-dosePopulation: All participants who received at least one dose of study drug and had evaluable PK data.
Outcome measures
| Measure |
R (Fasted)
n=18 Participants
LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Reference formulation for fasted group
|
T (Fasted)
n=17 Participants
LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Test formulation for fasted group.
|
T (Fed)
n=18 Participants
LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Test formulation for non-fasted group
|
|---|---|---|---|
|
PK: Time of Maximum Observed Drug Concentration (Tmax) of LY3314814 (AZD3293)
18 to 55 Years
|
2.00 Hour (h)
Interval 1.0 to 4.0
|
1.50 Hour (h)
Interval 1.0 to 3.02
|
4.01 Hour (h)
Interval 1.5 to 8.0
|
|
PK: Time of Maximum Observed Drug Concentration (Tmax) of LY3314814 (AZD3293)
> 55 Years
|
2.26 Hour (h)
Interval 1.0 to 4.12
|
1.50 Hour (h)
Interval 1.0 to 4.0
|
3.50 Hour (h)
Interval 1.5 to 6.0
|
PRIMARY outcome
Timeframe: Day 1 of Periods 1, 2, and 3: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56, 72, 96, and 120 hours post-dosePopulation: All participants who received at least one dose of study drug and had evaluable PK data.
Outcome measures
| Measure |
R (Fasted)
n=18 Participants
LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Reference formulation for fasted group
|
T (Fasted)
n=17 Participants
LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Test formulation for fasted group.
|
T (Fed)
n=18 Participants
LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Test formulation for non-fasted group
|
|---|---|---|---|
|
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3314814 (AZD3293)
18 to 55 Years
|
2920 nanogram*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 12
|
2850 nanogram*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 13
|
2970 nanogram*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 9
|
|
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3314814 (AZD3293)
> 55 Years
|
3040 nanogram*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 16
|
3020 nanogram*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 27
|
2820 nanogram*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 23
|
Adverse Events
R (Fasted)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
T (Fasted)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
T (Fed)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
R (Fasted)
n=18 participants at risk
LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Reference formulation for fasted group
|
T (Fasted)
n=17 participants at risk
LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Test formulation for fasted group
|
T (Fed)
n=18 participants at risk
LY3314814 (AZD3293): 50 mg administered once PO in each of 3 treatment periods. Test formulation for non-fasted group
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/18
Adverse events were analyzed and presented per respective formulation.
|
0.00%
0/17
Adverse events were analyzed and presented per respective formulation.
|
5.6%
1/18 • Number of events 1
Adverse events were analyzed and presented per respective formulation.
|
|
Gastrointestinal disorders
Nausea
|
11.1%
2/18 • Number of events 2
Adverse events were analyzed and presented per respective formulation.
|
0.00%
0/17
Adverse events were analyzed and presented per respective formulation.
|
5.6%
1/18 • Number of events 1
Adverse events were analyzed and presented per respective formulation.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
1/18 • Number of events 1
Adverse events were analyzed and presented per respective formulation.
|
0.00%
0/17
Adverse events were analyzed and presented per respective formulation.
|
0.00%
0/18
Adverse events were analyzed and presented per respective formulation.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/18
Adverse events were analyzed and presented per respective formulation.
|
5.9%
1/17 • Number of events 1
Adverse events were analyzed and presented per respective formulation.
|
0.00%
0/18
Adverse events were analyzed and presented per respective formulation.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/18
Adverse events were analyzed and presented per respective formulation.
|
5.9%
1/17 • Number of events 1
Adverse events were analyzed and presented per respective formulation.
|
0.00%
0/18
Adverse events were analyzed and presented per respective formulation.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/18
Adverse events were analyzed and presented per respective formulation.
|
5.9%
1/17 • Number of events 1
Adverse events were analyzed and presented per respective formulation.
|
0.00%
0/18
Adverse events were analyzed and presented per respective formulation.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/18
Adverse events were analyzed and presented per respective formulation.
|
11.8%
2/17 • Number of events 2
Adverse events were analyzed and presented per respective formulation.
|
0.00%
0/18
Adverse events were analyzed and presented per respective formulation.
|
|
Nervous system disorders
Headache
|
5.6%
1/18 • Number of events 1
Adverse events were analyzed and presented per respective formulation.
|
5.9%
1/17 • Number of events 3
Adverse events were analyzed and presented per respective formulation.
|
16.7%
3/18 • Number of events 3
Adverse events were analyzed and presented per respective formulation.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.6%
1/18 • Number of events 1
Adverse events were analyzed and presented per respective formulation.
|
0.00%
0/17
Adverse events were analyzed and presented per respective formulation.
|
0.00%
0/18
Adverse events were analyzed and presented per respective formulation.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/18
Adverse events were analyzed and presented per respective formulation.
|
5.9%
1/17 • Number of events 1
Adverse events were analyzed and presented per respective formulation.
|
0.00%
0/18
Adverse events were analyzed and presented per respective formulation.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/18
Adverse events were analyzed and presented per respective formulation.
|
5.9%
1/17 • Number of events 1
Adverse events were analyzed and presented per respective formulation.
|
0.00%
0/18
Adverse events were analyzed and presented per respective formulation.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
5.6%
1/18 • Number of events 1
Adverse events were analyzed and presented per respective formulation.
|
0.00%
0/17
Adverse events were analyzed and presented per respective formulation.
|
0.00%
0/18
Adverse events were analyzed and presented per respective formulation.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/18
Adverse events were analyzed and presented per respective formulation.
|
5.9%
1/17 • Number of events 1
Adverse events were analyzed and presented per respective formulation.
|
0.00%
0/18
Adverse events were analyzed and presented per respective formulation.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5079
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60