Trial Outcomes & Findings for A Study of LY2409021 Formulations and the Effect of Food (NCT NCT01354496)
NCT ID: NCT01354496
Last Updated: 2019-03-11
Results Overview
AUC from time 0 to infinity (AUC0-∞).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
35 participants
Primary outcome timeframe
Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
Results posted on
2019-03-11
Participant Flow
Participant milestones
| Measure |
LY2409021 Cohort 1: Sequence 1
Sequence 1: (Period 1:reference capsules fasting, then Period 2: test-medium tablet fasting, then Period 3: test-medium tablet after high-fat meal).
There was a washout period of at least 14 days between interventions. Description of interventions: reference capsules fasting \[20-milligram (mg) LY2409021 dose, administered orally, once in fasted state\], test-medium tablet fasting (20-mg LY2409021 tablet, medium particle size, administered orally, once in fasted state), and test-medium tablet after high-fat meal (20-mg LY2409021 tablet, medium particle size, administered orally, once, immediately after standardized high-fat meal).
|
LY2409021 Cohort 1: Sequence 2
Sequence 2: (Period 1: test-medium tablet fasting, then Period 2: test-medium tablet after high-fat meal, then Period 3: reference capsules fasting).
There was a washout period of at least 14 days between interventions. Description of interventions: reference capsules fasting \[20-milligram (mg) LY2409021 dose, administered orally, once in fasted state\], test-medium tablet fasting (20-mg LY2409021 tablet, medium particle size, administered orally, once in fasted state), and test-medium tablet after high-fat meal (20-mg LY2409021 tablet, medium particle size, administered orally, once, immediately after standardized high-fat meal).
|
LY2409021 Cohort 1: Sequence 3
Sequence 3: (Period 1:test-medium tablet after high-fat meal, then Period 2: reference capsules fasting, then Period 3: test-medium tablet fasting).
There was a washout period of at least 14 days between interventions. Description of interventions: reference capsules fasting \[20-milligram (mg) LY2409021 dose, administered orally, once in fasted state\], test-medium tablet fasting (20-mg LY2409021 tablet, medium particle size, administered orally, once in fasted state), and test-medium tablet after high-fat meal (20-mg LY2409021 tablet, medium particle size, administered orally, once, immediately after standardized high-fat meal).
|
LY2409021 Cohort 2: Sequence 4
Sequence 4: (Period 1: test-medium tablet fasting then, Period 2: test-high tablet fasting, then Period 3: test-low tablet fasting) There was a washout period of at least 14 days between interventions. Description of interventions: test-low tablet fasting (single 20-mg LY2409021 tablet of a low particle size, administered orally in a fasted state), test-medium tablet fasting (single 20-mg LY2409021 tablet of a medium particle size, administered orally, once in a fasted state), and test-high tablet fasting (single 20-mg LY2409021 tablet of a high particle size administered orally, once in a fasted state).
|
LY2409021 Cohort 2: Sequence 5
Sequence 5: (Period 1: test-high tablet fasting then, Period 2: test-low tablet fasting, then Period 3: test-medium tablet fasting) There was a washout period of at least 14 days between interventions. Description of interventions: test-low tablet fasting (single 20-mg LY2409021 tablet of a low particle size, administered orally in a fasted state), test-medium tablet fasting (single 20-mg LY2409021 tablet of a medium particle size, administered orally, once in a fasted state), and test-high tablet fasting (single 20-mg LY2409021 tablet of a high particle size administered orally, once in a fasted state).
|
LY2409021 Cohort 2: Sequence 6
Sequence 6: (Period1: test-low tablet fasting, then Period 2: test-medium tablet fasting, then Period 3: test-high tablet fasting).
There was a washout period of at least 14 days between interventions. Description of interventions: test-low tablet fasting (single 20-mg LY2409021 tablet of a low particle size, administered orally in a fasted state), test-medium tablet fasting (single 20-mg LY2409021 tablet of a medium particle size, administered orally, once in a fasted state), and test-high tablet fasting (single 20-mg LY2409021 tablet of a high particle size administered orally, once in a fasted state).
|
|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
6
|
6
|
6
|
6
|
5
|
6
|
|
Period 1
Received at Least 1 Dose of Study Drug
|
6
|
6
|
6
|
6
|
5
|
6
|
|
Period 1
COMPLETED
|
6
|
6
|
4
|
6
|
5
|
6
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Washout (at Least 14 Days)
STARTED
|
6
|
6
|
4
|
5
|
5
|
6
|
|
Washout (at Least 14 Days)
COMPLETED
|
6
|
5
|
4
|
4
|
5
|
6
|
|
Washout (at Least 14 Days)
NOT COMPLETED
|
0
|
1
|
0
|
1
|
0
|
0
|
|
Period 2
STARTED
|
6
|
6
|
4
|
6
|
5
|
6
|
|
Period 2
COMPLETED
|
6
|
6
|
4
|
5
|
5
|
6
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Period 3
STARTED
|
6
|
5
|
4
|
4
|
5
|
6
|
|
Period 3
COMPLETED
|
6
|
5
|
4
|
4
|
5
|
6
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
LY2409021 Cohort 1: Sequence 1
Sequence 1: (Period 1:reference capsules fasting, then Period 2: test-medium tablet fasting, then Period 3: test-medium tablet after high-fat meal).
There was a washout period of at least 14 days between interventions. Description of interventions: reference capsules fasting \[20-milligram (mg) LY2409021 dose, administered orally, once in fasted state\], test-medium tablet fasting (20-mg LY2409021 tablet, medium particle size, administered orally, once in fasted state), and test-medium tablet after high-fat meal (20-mg LY2409021 tablet, medium particle size, administered orally, once, immediately after standardized high-fat meal).
|
LY2409021 Cohort 1: Sequence 2
Sequence 2: (Period 1: test-medium tablet fasting, then Period 2: test-medium tablet after high-fat meal, then Period 3: reference capsules fasting).
There was a washout period of at least 14 days between interventions. Description of interventions: reference capsules fasting \[20-milligram (mg) LY2409021 dose, administered orally, once in fasted state\], test-medium tablet fasting (20-mg LY2409021 tablet, medium particle size, administered orally, once in fasted state), and test-medium tablet after high-fat meal (20-mg LY2409021 tablet, medium particle size, administered orally, once, immediately after standardized high-fat meal).
|
LY2409021 Cohort 1: Sequence 3
Sequence 3: (Period 1:test-medium tablet after high-fat meal, then Period 2: reference capsules fasting, then Period 3: test-medium tablet fasting).
There was a washout period of at least 14 days between interventions. Description of interventions: reference capsules fasting \[20-milligram (mg) LY2409021 dose, administered orally, once in fasted state\], test-medium tablet fasting (20-mg LY2409021 tablet, medium particle size, administered orally, once in fasted state), and test-medium tablet after high-fat meal (20-mg LY2409021 tablet, medium particle size, administered orally, once, immediately after standardized high-fat meal).
|
LY2409021 Cohort 2: Sequence 4
Sequence 4: (Period 1: test-medium tablet fasting then, Period 2: test-high tablet fasting, then Period 3: test-low tablet fasting) There was a washout period of at least 14 days between interventions. Description of interventions: test-low tablet fasting (single 20-mg LY2409021 tablet of a low particle size, administered orally in a fasted state), test-medium tablet fasting (single 20-mg LY2409021 tablet of a medium particle size, administered orally, once in a fasted state), and test-high tablet fasting (single 20-mg LY2409021 tablet of a high particle size administered orally, once in a fasted state).
|
LY2409021 Cohort 2: Sequence 5
Sequence 5: (Period 1: test-high tablet fasting then, Period 2: test-low tablet fasting, then Period 3: test-medium tablet fasting) There was a washout period of at least 14 days between interventions. Description of interventions: test-low tablet fasting (single 20-mg LY2409021 tablet of a low particle size, administered orally in a fasted state), test-medium tablet fasting (single 20-mg LY2409021 tablet of a medium particle size, administered orally, once in a fasted state), and test-high tablet fasting (single 20-mg LY2409021 tablet of a high particle size administered orally, once in a fasted state).
|
LY2409021 Cohort 2: Sequence 6
Sequence 6: (Period1: test-low tablet fasting, then Period 2: test-medium tablet fasting, then Period 3: test-high tablet fasting).
There was a washout period of at least 14 days between interventions. Description of interventions: test-low tablet fasting (single 20-mg LY2409021 tablet of a low particle size, administered orally in a fasted state), test-medium tablet fasting (single 20-mg LY2409021 tablet of a medium particle size, administered orally, once in a fasted state), and test-high tablet fasting (single 20-mg LY2409021 tablet of a high particle size administered orally, once in a fasted state).
|
|---|---|---|---|---|---|---|
|
Period 1
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Period 1
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Period 2
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Washout (at Least 14 Days)
Scheduling Conflict
|
0
|
1
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study of LY2409021 Formulations and the Effect of Food
Baseline characteristics by cohort
| Measure |
LY2409021 Cohort 1
n=18 Participants
Participants randomized to 1 of 3 sequences and received a single but different intervention per period: Sequence 1 (reference capsules fasting, then test-medium tablet fasting, then test-medium tablet after high-fat meal), Sequence 2 (test-medium tablet fasting, then test-medium tablet after high-fat meal, then reference capsules fasting), or Sequence 3 (test-medium tablet after high-fat meal, then reference capsules fasting, then test-medium tablet fasting).
There was a washout period of at least 14 days between interventions. Description of interventions: reference capsules fasting \[20-milligram (mg) LY2409021 dose, administered orally, once in fasted state\], test-medium tablet fasting (20-mg LY2409021 tablet, medium particle size, administered orally, once in fasted state), and test-medium tablet after high-fat meal (20-mg LY2409021 tablet, medium particle size, administered orally, once, immediately after standardized high-fat meal).
|
LY2409021 Cohort 2
n=17 Participants
Participants randomized to 1 of 3 sequences and received a single but different intervention per period: Sequence 4 (test-medium tablet fasting then, test-high tablet fasting, then test-low tablet fasting), Sequence 5 (test-high tablet fasting then, test-low tablet fasting, then test-medium tablet fasting), or Sequence 6 (test-low tablet fasting, then test-medium tablet fasting, then test-high tablet fasting).
There was a washout period of at least 14 days between interventions. Description of interventions: test-low tablet fasting (single 20-mg LY2409021 tablet of a low particle size, administered orally in a fasted state), test-medium tablet fasting (single 20-mg LY2409021 tablet of a medium particle size, administered orally, once in a fasted state), and test-high tablet fasting (single 20-mg LY2409021 tablet of a high particle size administered orally, once in a fasted state).
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.4 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
32.6 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
33.6 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Region of Enrollment
Singapore
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)Population: Randomized participants in Cohort 1 who received the specified study drug.
AUC from time 0 to infinity (AUC0-∞).
Outcome measures
| Measure |
LY2409021 Cohort 1 (Test-Medium Tablet Fasted)
n=16 Participants
A single 20-milligram (mg) LY2409021 tablet of a medium particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
|
LY2409021 Cohort 1 (Reference Capsules Fasted)
n=15 Participants
A 20-mg LY2409021 dose administered orally, once in a fasted state, during Period 1, 2, or 3.
|
LY2409021 Cohort 1 (Test-Medium Tablet Fasted)
A single 20-mg LY2409021 tablet of a medium particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
|
LY2409021 Cohort 2 (Test-Low Tablet Fasted)
A single 20-mg LY2409021 tablet of a low particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
|
LY2409021 Cohort 2 (Test-Medium Tablet Fasted)
A single 20-mg LY2409021 tablet of a medium particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
|
LY2409021 Cohort 2 (Test-High Tablet Fasted)
A single 20-mg LY2409021 tablet of a high particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics, Area Under the Concentration-Time Curve (AUC): Medium Test Form to Reference Form
|
65300 nanograms*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 20
|
62800 nanograms*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 38
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)Population: Randomized participants in Cohort 1 who received the specified study drug.
Outcome measures
| Measure |
LY2409021 Cohort 1 (Test-Medium Tablet Fasted)
n=16 Participants
A single 20-milligram (mg) LY2409021 tablet of a medium particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
|
LY2409021 Cohort 1 (Reference Capsules Fasted)
n=15 Participants
A 20-mg LY2409021 dose administered orally, once in a fasted state, during Period 1, 2, or 3.
|
LY2409021 Cohort 1 (Test-Medium Tablet Fasted)
A single 20-mg LY2409021 tablet of a medium particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
|
LY2409021 Cohort 2 (Test-Low Tablet Fasted)
A single 20-mg LY2409021 tablet of a low particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
|
LY2409021 Cohort 2 (Test-Medium Tablet Fasted)
A single 20-mg LY2409021 tablet of a medium particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
|
LY2409021 Cohort 2 (Test-High Tablet Fasted)
A single 20-mg LY2409021 tablet of a high particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics, Maximum Concentration (Cmax): Medium Test Form to Reference Form
|
779 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 19
|
726 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 41
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)Population: Randomized participants in Cohort 1 who received the specified study drug.
AUC from time 0 to infinity (AUC0-∞).
Outcome measures
| Measure |
LY2409021 Cohort 1 (Test-Medium Tablet Fasted)
n=18 Participants
A single 20-milligram (mg) LY2409021 tablet of a medium particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
|
LY2409021 Cohort 1 (Reference Capsules Fasted)
n=16 Participants
A 20-mg LY2409021 dose administered orally, once in a fasted state, during Period 1, 2, or 3.
|
LY2409021 Cohort 1 (Test-Medium Tablet Fasted)
A single 20-mg LY2409021 tablet of a medium particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
|
LY2409021 Cohort 2 (Test-Low Tablet Fasted)
A single 20-mg LY2409021 tablet of a low particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
|
LY2409021 Cohort 2 (Test-Medium Tablet Fasted)
A single 20-mg LY2409021 tablet of a medium particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
|
LY2409021 Cohort 2 (Test-High Tablet Fasted)
A single 20-mg LY2409021 tablet of a high particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics, Area Under the Concentration-Time Curve (AUC): Standardized High Fat Meal to Fasting
|
67000 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 18
|
65300 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 20
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)Population: Randomized participants in Cohort 1 who received the specified study drug.
Outcome measures
| Measure |
LY2409021 Cohort 1 (Test-Medium Tablet Fasted)
n=18 Participants
A single 20-milligram (mg) LY2409021 tablet of a medium particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
|
LY2409021 Cohort 1 (Reference Capsules Fasted)
n=16 Participants
A 20-mg LY2409021 dose administered orally, once in a fasted state, during Period 1, 2, or 3.
|
LY2409021 Cohort 1 (Test-Medium Tablet Fasted)
A single 20-mg LY2409021 tablet of a medium particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
|
LY2409021 Cohort 2 (Test-Low Tablet Fasted)
A single 20-mg LY2409021 tablet of a low particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
|
LY2409021 Cohort 2 (Test-Medium Tablet Fasted)
A single 20-mg LY2409021 tablet of a medium particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
|
LY2409021 Cohort 2 (Test-High Tablet Fasted)
A single 20-mg LY2409021 tablet of a high particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics, Maximum Concentration (Cmax): Standardized High Fat Meal to Fasting
|
785 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 14
|
779 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 19
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)Population: Randomized participants in Cohorts 1 and 2 who received the specified study drug.
Outcome measures
| Measure |
LY2409021 Cohort 1 (Test-Medium Tablet Fasted)
n=15 Participants
A single 20-milligram (mg) LY2409021 tablet of a medium particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
|
LY2409021 Cohort 1 (Reference Capsules Fasted)
n=18 Participants
A 20-mg LY2409021 dose administered orally, once in a fasted state, during Period 1, 2, or 3.
|
LY2409021 Cohort 1 (Test-Medium Tablet Fasted)
n=16 Participants
A single 20-mg LY2409021 tablet of a medium particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
|
LY2409021 Cohort 2 (Test-Low Tablet Fasted)
n=15 Participants
A single 20-mg LY2409021 tablet of a low particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
|
LY2409021 Cohort 2 (Test-Medium Tablet Fasted)
n=17 Participants
A single 20-mg LY2409021 tablet of a medium particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
|
LY2409021 Cohort 2 (Test-High Tablet Fasted)
n=17 Participants
A single 20-mg LY2409021 tablet of a high particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics, Time to Maximum Concentration (Tmax)
|
8.00 hour (hr)
Interval 4.0 to 12.0
|
8.00 hour (hr)
Interval 4.0 to 24.0
|
8.00 hour (hr)
Interval 4.0 to 12.0
|
4.00 hour (hr)
Interval 4.0 to 10.0
|
8.00 hour (hr)
Interval 4.0 to 18.0
|
8.00 hour (hr)
Interval 4.0 to 10.0
|
SECONDARY outcome
Timeframe: Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)Population: Randomized participants in Cohort 2 who received the specified study drug.
AUC from time 0 to infinity (AUC0-∞).
Outcome measures
| Measure |
LY2409021 Cohort 1 (Test-Medium Tablet Fasted)
n=15 Participants
A single 20-milligram (mg) LY2409021 tablet of a medium particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
|
LY2409021 Cohort 1 (Reference Capsules Fasted)
n=17 Participants
A 20-mg LY2409021 dose administered orally, once in a fasted state, during Period 1, 2, or 3.
|
LY2409021 Cohort 1 (Test-Medium Tablet Fasted)
n=17 Participants
A single 20-mg LY2409021 tablet of a medium particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
|
LY2409021 Cohort 2 (Test-Low Tablet Fasted)
A single 20-mg LY2409021 tablet of a low particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
|
LY2409021 Cohort 2 (Test-Medium Tablet Fasted)
A single 20-mg LY2409021 tablet of a medium particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
|
LY2409021 Cohort 2 (Test-High Tablet Fasted)
A single 20-mg LY2409021 tablet of a high particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics, Area Under the Concentration-Time Curve (AUC): Low and High Particle Size to Medium Particle Size
|
73700 nanograms*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 16
|
69400 nanograms*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 18
|
73600 nanograms*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 17
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)Population: Randomized participants in Cohort 2 who received the specified study drug.
Outcome measures
| Measure |
LY2409021 Cohort 1 (Test-Medium Tablet Fasted)
n=15 Participants
A single 20-milligram (mg) LY2409021 tablet of a medium particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
|
LY2409021 Cohort 1 (Reference Capsules Fasted)
n=17 Participants
A 20-mg LY2409021 dose administered orally, once in a fasted state, during Period 1, 2, or 3.
|
LY2409021 Cohort 1 (Test-Medium Tablet Fasted)
n=17 Participants
A single 20-mg LY2409021 tablet of a medium particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
|
LY2409021 Cohort 2 (Test-Low Tablet Fasted)
A single 20-mg LY2409021 tablet of a low particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
|
LY2409021 Cohort 2 (Test-Medium Tablet Fasted)
A single 20-mg LY2409021 tablet of a medium particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
|
LY2409021 Cohort 2 (Test-High Tablet Fasted)
A single 20-mg LY2409021 tablet of a high particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics, Concentration Maximum (Cmax): Low and High Particle Size to Medium Particle Size
|
835 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 20
|
793 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 20
|
844 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 20
|
—
|
—
|
—
|
Adverse Events
LY2409021 Cohort 1 (Reference Capsules Fasted)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
LY2409021 Cohort 1 (Test-Medium Tablet Fed)
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
LY2409021 Cohort 2 (Test-Low Tablet Fasted)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
LY2409021 Cohorts 1 and 2 (Test-Medium Tablet Fasted)
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
LY2409021 Cohort 2 (Test-High Tablet Fasted)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LY2409021 Cohort 1 (Reference Capsules Fasted)
n=15 participants at risk
A 20-mg LY2409021 dose administered orally, once in a fasted state, during Period 1, 2, or 3.
|
LY2409021 Cohort 1 (Test-Medium Tablet Fed)
n=18 participants at risk
A single 20-mg LY2409021 tablet of a medium particle size administered orally, once, immediately after a standardized high-fat meal, during Period 1, 2, or 3.
|
LY2409021 Cohort 2 (Test-Low Tablet Fasted)
n=15 participants at risk
A single 20-mg LY2409021 tablet of a low particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
|
LY2409021 Cohorts 1 and 2 (Test-Medium Tablet Fasted)
n=33 participants at risk
A single 20-mg LY2409021 tablet of a medium particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
|
LY2409021 Cohort 2 (Test-High Tablet Fasted)
n=17 participants at risk
A single 20-mg LY2409021 tablet of a high particle size administered orally, once in a fasted state, during Period 1, 2, or 3.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/15
|
0.00%
0/18
|
0.00%
0/15
|
0.00%
0/33
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/15
|
0.00%
0/18
|
13.3%
2/15 • Number of events 2
|
3.0%
1/33 • Number of events 1
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/15
|
5.6%
1/18 • Number of events 1
|
0.00%
0/15
|
0.00%
0/33
|
0.00%
0/17
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/15
|
0.00%
0/18
|
6.7%
1/15 • Number of events 1
|
0.00%
0/33
|
0.00%
0/17
|
|
General disorders
Hunger
|
6.7%
1/15 • Number of events 1
|
5.6%
1/18 • Number of events 2
|
20.0%
3/15 • Number of events 3
|
3.0%
1/33 • Number of events 1
|
11.8%
2/17 • Number of events 2
|
|
General disorders
Vessel puncture site haematoma
|
26.7%
4/15 • Number of events 5
|
33.3%
6/18 • Number of events 10
|
13.3%
2/15 • Number of events 2
|
27.3%
9/33 • Number of events 12
|
17.6%
3/17 • Number of events 4
|
|
General disorders
Vessel puncture site pain
|
13.3%
2/15 • Number of events 3
|
5.6%
1/18 • Number of events 1
|
0.00%
0/15
|
6.1%
2/33 • Number of events 3
|
11.8%
2/17 • Number of events 2
|
|
General disorders
Vessel puncture site reaction
|
6.7%
1/15 • Number of events 1
|
11.1%
2/18 • Number of events 2
|
0.00%
0/15
|
3.0%
1/33 • Number of events 1
|
5.9%
1/17 • Number of events 1
|
|
General disorders
Vessel puncture site swelling
|
20.0%
3/15 • Number of events 3
|
11.1%
2/18 • Number of events 2
|
0.00%
0/15
|
3.0%
1/33 • Number of events 1
|
0.00%
0/17
|
|
Infections and infestations
Hordeolum
|
0.00%
0/15
|
0.00%
0/18
|
6.7%
1/15 • Number of events 1
|
0.00%
0/33
|
0.00%
0/17
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/15
|
0.00%
0/18
|
6.7%
1/15 • Number of events 1
|
0.00%
0/33
|
0.00%
0/17
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/15
|
0.00%
0/18
|
0.00%
0/15
|
6.1%
2/33 • Number of events 2
|
5.9%
1/17 • Number of events 1
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
40.0%
6/15 • Number of events 8
|
50.0%
9/18 • Number of events 13
|
20.0%
3/15 • Number of events 3
|
30.3%
10/33 • Number of events 15
|
5.9%
1/17 • Number of events 1
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/15
|
0.00%
0/18
|
0.00%
0/15
|
0.00%
0/33
|
5.9%
1/17 • Number of events 1
|
|
Investigations
Coagulation time prolonged
|
6.7%
1/15 • Number of events 1
|
0.00%
0/18
|
0.00%
0/15
|
0.00%
0/33
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.7%
1/15 • Number of events 1
|
0.00%
0/18
|
0.00%
0/15
|
0.00%
0/33
|
5.9%
1/17 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/15
|
0.00%
0/18
|
0.00%
0/15
|
6.1%
2/33 • Number of events 2
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/15
|
0.00%
0/18
|
0.00%
0/15
|
0.00%
0/33
|
5.9%
1/17 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/15
|
0.00%
0/18
|
0.00%
0/15
|
6.1%
2/33 • Number of events 2
|
0.00%
0/17
|
|
Nervous system disorders
Headache
|
13.3%
2/15 • Number of events 2
|
0.00%
0/18
|
0.00%
0/15
|
15.2%
5/33 • Number of events 5
|
0.00%
0/17
|
|
Nervous system disorders
Lethargy
|
0.00%
0/15
|
5.6%
1/18 • Number of events 1
|
0.00%
0/15
|
0.00%
0/33
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/15
|
5.6%
1/18 • Number of events 1
|
0.00%
0/15
|
3.0%
1/33 • Number of events 1
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/15
|
0.00%
0/18
|
6.7%
1/15 • Number of events 1
|
0.00%
0/33
|
5.9%
1/17 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.7%
1/15 • Number of events 1
|
11.1%
2/18 • Number of events 2
|
0.00%
0/15
|
9.1%
3/33 • Number of events 3
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/15
|
11.1%
2/18 • Number of events 2
|
0.00%
0/15
|
0.00%
0/33
|
5.9%
1/17 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
13.3%
2/15 • Number of events 2
|
5.6%
1/18 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
6.1%
2/33 • Number of events 2
|
11.8%
2/17 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.7%
1/15 • Number of events 1
|
0.00%
0/18
|
0.00%
0/15
|
0.00%
0/33
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/15
|
0.00%
0/18
|
0.00%
0/15
|
6.1%
2/33 • Number of events 2
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/15
|
5.6%
1/18 • Number of events 1
|
0.00%
0/15
|
0.00%
0/33
|
0.00%
0/17
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place