Trial Outcomes & Findings for A Study of LY2409021 Formulations in Healthy Participants (NCT NCT02385084)
NCT ID: NCT02385084
Last Updated: 2018-10-29
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
Day 1: Predose, 0.5 Hours (H), 1 H, 4 H, 8 H, 12 H, 24 H, 48 H, 72 H, 96 H, 144 H, 192 H, 264 H, 336 H Postdose in Each Period
Results posted on
2018-10-29
Participant Flow
This study was designed to have two parts. During Part A, decision was made to terminate the study. Participants in Part A were allowed to complete the study. Part B was not conducted.
Participant milestones
| Measure |
LY2409021 Capsules/T2/T3 (Part A)
Period 1: 20 milligrams (mg) LY2409021 administered as capsules once, orally.
Period 2: 20 mg LY2409021 administered as a pre-commercial tablet (T2) once, orally.
Period 3: 20 mg LY2409021 administered as a commercial tablet (T3) once, orally.
There were at least 15 days between doses of study drug (washout).
|
LY2409021 T2/Capsules/T3 (Part A)
Period 1: 20 mg LY2409021 administered as T2 once, orally.
Period 2: 20 mg LY2409021 administered as capsules once, orally.
Period 3: 20 mg LY2409021 administered as T3 once, orally.
There were at least 15 days between doses of study drug (washout).
|
LY2409021 T3/T2/Capsules (Part A)
Period 1: 20 mg LY2409021 administered as T3 once, orally.
Period 2: 20 mg LY2409021 administered as T2 once, orally.
Period 3: 20 mg LY2409021 administered as capsules once, orally.
There were at least 15 days between doses of study drug (washout).
|
LY2409021 T3/Capsules/T2 (Part A)
Period 1: 20 mg LY2409021 administered as T3 once, orally.
Period 2: 20 mg LY2409021 administered as capsules once, orally.
Period 3: 20 mg LY2409021 administered as T2 once, orally.
There were at least 15 days between doses of study drug (washout).
|
LY2409021 T2/T3/Capsules (Part A)
Period 1: 20 mg LY2409021 administered as T2 once, orally.
Period 2: 20 mg LY2409021 administered as T3 once, orally.
Period 3: 20 mg LY2409021 administered as capsules once, orally.
There were at least 15 days between doses of study drug (washout).
|
LY2409021 Capsules/T3/T2 (Part A)
Period 1: 20 mg LY2409021 administered as capsules once, orally.
Period 2: 20 mg LY2409021 administered as T3 once, orally.
Period 3: 20 mg LY2409021 administered as T2 once, orally.
There were at least 15 days between doses of study drug (washout).
|
|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Period 1
Received LY2409021
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Period 1
Washout
|
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
|
2
|
3
|
3
|
3
|
3
|
3
|
|
Period 2
Received LY2409021
|
2
|
3
|
3
|
3
|
3
|
3
|
|
Period 2
Washout
|
2
|
3
|
3
|
3
|
3
|
3
|
|
Period 2
COMPLETED
|
2
|
3
|
2
|
3
|
3
|
3
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Period 3
STARTED
|
2
|
3
|
1
|
3
|
2
|
3
|
|
Period 3
Received LY2409021
|
2
|
3
|
1
|
3
|
2
|
3
|
|
Period 3
Washout
|
2
|
3
|
1
|
3
|
2
|
3
|
|
Period 3
COMPLETED
|
2
|
3
|
1
|
3
|
2
|
3
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
LY2409021 Capsules/T2/T3 (Part A)
Period 1: 20 milligrams (mg) LY2409021 administered as capsules once, orally.
Period 2: 20 mg LY2409021 administered as a pre-commercial tablet (T2) once, orally.
Period 3: 20 mg LY2409021 administered as a commercial tablet (T3) once, orally.
There were at least 15 days between doses of study drug (washout).
|
LY2409021 T2/Capsules/T3 (Part A)
Period 1: 20 mg LY2409021 administered as T2 once, orally.
Period 2: 20 mg LY2409021 administered as capsules once, orally.
Period 3: 20 mg LY2409021 administered as T3 once, orally.
There were at least 15 days between doses of study drug (washout).
|
LY2409021 T3/T2/Capsules (Part A)
Period 1: 20 mg LY2409021 administered as T3 once, orally.
Period 2: 20 mg LY2409021 administered as T2 once, orally.
Period 3: 20 mg LY2409021 administered as capsules once, orally.
There were at least 15 days between doses of study drug (washout).
|
LY2409021 T3/Capsules/T2 (Part A)
Period 1: 20 mg LY2409021 administered as T3 once, orally.
Period 2: 20 mg LY2409021 administered as capsules once, orally.
Period 3: 20 mg LY2409021 administered as T2 once, orally.
There were at least 15 days between doses of study drug (washout).
|
LY2409021 T2/T3/Capsules (Part A)
Period 1: 20 mg LY2409021 administered as T2 once, orally.
Period 2: 20 mg LY2409021 administered as T3 once, orally.
Period 3: 20 mg LY2409021 administered as capsules once, orally.
There were at least 15 days between doses of study drug (washout).
|
LY2409021 Capsules/T3/T2 (Part A)
Period 1: 20 mg LY2409021 administered as capsules once, orally.
Period 2: 20 mg LY2409021 administered as T3 once, orally.
Period 3: 20 mg LY2409021 administered as T2 once, orally.
There were at least 15 days between doses of study drug (washout).
|
|---|---|---|---|---|---|---|
|
Period 2
Protocol Violation
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study of LY2409021 Formulations in Healthy Participants
Baseline characteristics by cohort
| Measure |
LY2409021 (Part A)
n=18 Participants
20 mg LY2409021 administered as capsules, T2, or T3 once, orally in each of 3 study periods.
|
|---|---|
|
Age, Continuous
|
44.4 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1: Predose, 0.5 Hours (H), 1 H, 4 H, 8 H, 12 H, 24 H, 48 H, 72 H, 96 H, 144 H, 192 H, 264 H, 336 H Postdose in Each PeriodPopulation: All participants who received the LY2409021 formulation and had evaluable AUC(0-inf) values. PK data for 1 participant who met study exclusion criteria was excluded from analyses. This participant only received the capsule formulation.
Outcome measures
| Measure |
LY2409021 Capsules (Part A)
n=14 Participants
20 mg LY2409021 administered as capsules once, orally in 1 of 3 study periods.
|
LY2409021 T2 (Part A)
n=17 Participants
20 mg LY2409021 administered as T2 once, orally in 1 of 3 study periods.
|
LY2409021 T3 (Part A)
n=17 Participants
20 mg LY2409021 T3 administered once, orally in 1 of 3 study periods.
|
|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY2409021
|
56400 nanograms x hours/milliliters (ng•h/mL
Geometric Coefficient of Variation 17
|
55700 nanograms x hours/milliliters (ng•h/mL
Geometric Coefficient of Variation 24
|
59100 nanograms x hours/milliliters (ng•h/mL
Geometric Coefficient of Variation 15
|
PRIMARY outcome
Timeframe: Day 1: Predose, 0.5 H, 1 H, 4 H, 8 H, 12 H, 24 H, 48 H, 72 H, 96 H, 144 H, 192 H, 264 H, 336 H Postdose in Each PeriodPopulation: All participants who received the LY2409021 formulation and had evaluable Cmax values. PK data for 1 participant who met study exclusion criteria was excluded from analyses. This participant only received the capsule formulation.
Outcome measures
| Measure |
LY2409021 Capsules (Part A)
n=14 Participants
20 mg LY2409021 administered as capsules once, orally in 1 of 3 study periods.
|
LY2409021 T2 (Part A)
n=17 Participants
20 mg LY2409021 administered as T2 once, orally in 1 of 3 study periods.
|
LY2409021 T3 (Part A)
n=17 Participants
20 mg LY2409021 T3 administered once, orally in 1 of 3 study periods.
|
|---|---|---|---|
|
PK: Maximum Plasma Concentration (Cmax) of LY2409021
|
724 ng/mL
Geometric Coefficient of Variation 18
|
718 ng/mL
Geometric Coefficient of Variation 30
|
760 ng/mL
Geometric Coefficient of Variation 20
|
Adverse Events
LY2409021 Capsules (Part A)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
LY2409021 T2 (Part A)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
LY2409021 T3 (Part A)
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 |
LY2409021 Capsules (Part A)
n=15 participants at risk
20 mg LY2409021 administered as capsules once, orally in 1 of 3 study periods.
|
LY2409021 T2 (Part A)
n=17 participants at risk
20 mg LY2409021 administered as T2 once, orally in 1 of 3 study periods.
|
LY2409021 T3 (Part A)
n=17 participants at risk
20 mg LY2409021 administered as T3 once, orally in 1 of 3 study periods.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/15
All participants who received at least 1 formulation of LY2409021.
|
0.00%
0/17
All participants who received at least 1 formulation of LY2409021.
|
5.9%
1/17 • Number of events 1
All participants who received at least 1 formulation of LY2409021.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/15
All participants who received at least 1 formulation of LY2409021.
|
0.00%
0/17
All participants who received at least 1 formulation of LY2409021.
|
5.9%
1/17 • Number of events 1
All participants who received at least 1 formulation of LY2409021.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
1/15 • Number of events 1
All participants who received at least 1 formulation of LY2409021.
|
0.00%
0/17
All participants who received at least 1 formulation of LY2409021.
|
0.00%
0/17
All participants who received at least 1 formulation of LY2409021.
|
|
General disorders
Asthenia
|
0.00%
0/15
All participants who received at least 1 formulation of LY2409021.
|
0.00%
0/17
All participants who received at least 1 formulation of LY2409021.
|
5.9%
1/17 • Number of events 1
All participants who received at least 1 formulation of LY2409021.
|
|
General disorders
Fatigue
|
0.00%
0/15
All participants who received at least 1 formulation of LY2409021.
|
0.00%
0/17
All participants who received at least 1 formulation of LY2409021.
|
5.9%
1/17 • Number of events 1
All participants who received at least 1 formulation of LY2409021.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
1/15 • Number of events 1
All participants who received at least 1 formulation of LY2409021.
|
5.9%
1/17 • Number of events 1
All participants who received at least 1 formulation of LY2409021.
|
0.00%
0/17
All participants who received at least 1 formulation of LY2409021.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/15
All participants who received at least 1 formulation of LY2409021.
|
0.00%
0/17
All participants who received at least 1 formulation of LY2409021.
|
5.9%
1/17 • Number of events 1
All participants who received at least 1 formulation of LY2409021.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.7%
1/15 • Number of events 1
All participants who received at least 1 formulation of LY2409021.
|
0.00%
0/17
All participants who received at least 1 formulation of LY2409021.
|
0.00%
0/17
All participants who received at least 1 formulation of LY2409021.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/15
All participants who received at least 1 formulation of LY2409021.
|
5.9%
1/17 • Number of events 1
All participants who received at least 1 formulation of LY2409021.
|
5.9%
1/17 • Number of events 2
All participants who received at least 1 formulation of LY2409021.
|
|
Nervous system disorders
Facial spasm
|
0.00%
0/15
All participants who received at least 1 formulation of LY2409021.
|
5.9%
1/17 • Number of events 1
All participants who received at least 1 formulation of LY2409021.
|
0.00%
0/17
All participants who received at least 1 formulation of LY2409021.
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • Number of events 1
All participants who received at least 1 formulation of LY2409021.
|
0.00%
0/17
All participants who received at least 1 formulation of LY2409021.
|
0.00%
0/17
All participants who received at least 1 formulation of LY2409021.
|
|
Psychiatric disorders
Insomnia
|
6.7%
1/15 • Number of events 1
All participants who received at least 1 formulation of LY2409021.
|
0.00%
0/17
All participants who received at least 1 formulation of LY2409021.
|
0.00%
0/17
All participants who received at least 1 formulation of LY2409021.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/15
All participants who received at least 1 formulation of LY2409021.
|
0.00%
0/17
All participants who received at least 1 formulation of LY2409021.
|
5.9%
1/17 • Number of events 1
All participants who received at least 1 formulation of LY2409021.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60