Trial Outcomes & Findings for A Study of Two Dosage Forms of LY2886721 in Healthy Participants (NCT NCT01775904)
NCT ID: NCT01775904
Last Updated: 2019-07-19
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
26 participants
Primary outcome timeframe
Baseline through 96 hours post-dose
Results posted on
2019-07-19
Participant Flow
Participant milestones
| Measure |
Total Study Population
All participants who entered the study and received at least 1 dose of study drug.
|
|---|---|
|
LY2886721 ODT (no Water, Fasting)
STARTED
|
26
|
|
LY2886721 ODT (no Water, Fasting)
Received at Least One Dose of Drug
|
26
|
|
LY2886721 ODT (no Water, Fasting)
COMPLETED
|
26
|
|
LY2886721 ODT (no Water, Fasting)
NOT COMPLETED
|
0
|
|
First Washout (7 Days)
STARTED
|
26
|
|
First Washout (7 Days)
COMPLETED
|
26
|
|
First Washout (7 Days)
NOT COMPLETED
|
0
|
|
LY2886721 Capsule (Water, Fasting)
STARTED
|
26
|
|
LY2886721 Capsule (Water, Fasting)
Received at Least One Dose of Drug
|
26
|
|
LY2886721 Capsule (Water, Fasting)
COMPLETED
|
25
|
|
LY2886721 Capsule (Water, Fasting)
NOT COMPLETED
|
1
|
|
Second Washout (7 Days)
STARTED
|
25
|
|
Second Washout (7 Days)
COMPLETED
|
25
|
|
Second Washout (7 Days)
NOT COMPLETED
|
0
|
|
LY2886721 ODT (Water, Fed)
STARTED
|
25
|
|
LY2886721 ODT (Water, Fed)
Received at Least One Dose of Drug
|
25
|
|
LY2886721 ODT (Water, Fed)
COMPLETED
|
25
|
|
LY2886721 ODT (Water, Fed)
NOT COMPLETED
|
0
|
|
Third Washout (7 Days)
STARTED
|
25
|
|
Third Washout (7 Days)
COMPLETED
|
25
|
|
Third Washout (7 Days)
NOT COMPLETED
|
0
|
|
LY2886721 ODT (Water, Fasting)
STARTED
|
25
|
|
LY2886721 ODT (Water, Fasting)
Received at Least One Dose of Drug
|
24
|
|
LY2886721 ODT (Water, Fasting)
COMPLETED
|
24
|
|
LY2886721 ODT (Water, Fasting)
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Total Study Population
All participants who entered the study and received at least 1 dose of study drug.
|
|---|---|
|
LY2886721 Capsule (Water, Fasting)
Adverse Event
|
1
|
|
LY2886721 ODT (Water, Fasting)
Adverse Event
|
1
|
Baseline Characteristics
A Study of Two Dosage Forms of LY2886721 in Healthy Participants
Baseline characteristics by cohort
| Measure |
Overall
n=26 Participants
All participants who entered the study and received at least 1 dose of study drug.
|
|---|---|
|
Age, Continuous
|
40.0 years
STANDARD_DEVIATION 17.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 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
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 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
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through 96 hours post-dosePopulation: Participants who received at least one dose of study drug with evaluable LY2886721 Cmax data.
Outcome measures
| Measure |
LY2886721 Capsule (Water, Fasting)
n=26 Participants
A single oral dose of 70 milligrams (mg) LY2886721 in a capsule given with water and without a meal in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods.
|
LY2886721 ODT (no Water, Fasting)
n=26 Participants
A single oral dose of 70 mg LY2886721 in an orally disintegrating tablet (ODT) given without water and without a meal in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods.
|
LY2886721 ODT (Water, Fed)
n=25 Participants
A single oral dose of 70 mg LY2886721 in an ODT given with water and after a high-fat breakfast in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods.
|
LY2886721 ODT (Water, Fasting)
n=24 Participants
A single oral dose of 70 mg LY2886721 in an ODT given with water and without a meal in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY2886721
|
183 nanograms / milliliter (ng/mL)
Geometric Coefficient of Variation 46
|
195 nanograms / milliliter (ng/mL)
Geometric Coefficient of Variation 29
|
181 nanograms / milliliter (ng/mL)
Geometric Coefficient of Variation 18
|
173 nanograms / milliliter (ng/mL)
Geometric Coefficient of Variation 37
|
PRIMARY outcome
Timeframe: Baseline through 96 hours post-dosePopulation: Participants who received at least one dose of study drug with evaluable LY2886721 tmax data.
Outcome measures
| Measure |
LY2886721 Capsule (Water, Fasting)
n=26 Participants
A single oral dose of 70 milligrams (mg) LY2886721 in a capsule given with water and without a meal in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods.
|
LY2886721 ODT (no Water, Fasting)
n=26 Participants
A single oral dose of 70 mg LY2886721 in an orally disintegrating tablet (ODT) given without water and without a meal in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods.
|
LY2886721 ODT (Water, Fed)
n=25 Participants
A single oral dose of 70 mg LY2886721 in an ODT given with water and after a high-fat breakfast in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods.
|
LY2886721 ODT (Water, Fasting)
n=24 Participants
A single oral dose of 70 mg LY2886721 in an ODT given with water and without a meal in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of LY2886721
|
3.00 hours
Interval 1.0 to 24.0
|
2.00 hours
Interval 1.0 to 4.0
|
4.00 hours
Interval 3.0 to 6.0
|
2.00 hours
Interval 1.0 to 12.0
|
PRIMARY outcome
Timeframe: Baseline through 96 hours post-dosePopulation: Participants who received at least one dose of study drug with evaluable LY2886721 AUC (0-tlast) data.
Outcome measures
| Measure |
LY2886721 Capsule (Water, Fasting)
n=26 Participants
A single oral dose of 70 milligrams (mg) LY2886721 in a capsule given with water and without a meal in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods.
|
LY2886721 ODT (no Water, Fasting)
n=26 Participants
A single oral dose of 70 mg LY2886721 in an orally disintegrating tablet (ODT) given without water and without a meal in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods.
|
LY2886721 ODT (Water, Fed)
n=25 Participants
A single oral dose of 70 mg LY2886721 in an ODT given with water and after a high-fat breakfast in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods.
|
LY2886721 ODT (Water, Fasting)
n=24 Participants
A single oral dose of 70 mg LY2886721 in an ODT given with water and without a meal in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Time Tlast (AUC[0-tlast]) of LY2886721
|
2300 nanograms * hour / milliliter
Geometric Coefficient of Variation 24
|
2380 nanograms * hour / milliliter
Geometric Coefficient of Variation 19
|
2480 nanograms * hour / milliliter
Geometric Coefficient of Variation 19
|
2270 nanograms * hour / milliliter
Geometric Coefficient of Variation 18
|
PRIMARY outcome
Timeframe: Baseline through 96 hours post-dosePopulation: Participants who received at least one dose of study drug with evaluable LY2886721 AUC (0-∞) data.
Outcome measures
| Measure |
LY2886721 Capsule (Water, Fasting)
n=26 Participants
A single oral dose of 70 milligrams (mg) LY2886721 in a capsule given with water and without a meal in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods.
|
LY2886721 ODT (no Water, Fasting)
n=26 Participants
A single oral dose of 70 mg LY2886721 in an orally disintegrating tablet (ODT) given without water and without a meal in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods.
|
LY2886721 ODT (Water, Fed)
n=25 Participants
A single oral dose of 70 mg LY2886721 in an ODT given with water and after a high-fat breakfast in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods.
|
LY2886721 ODT (Water, Fasting)
n=24 Participants
A single oral dose of 70 mg LY2886721 in an ODT given with water and without a meal in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞] of LY2886721
|
2320 nanograms * hour / milliliter
Geometric Coefficient of Variation 24
|
2390 nanograms * hour / milliliter
Geometric Coefficient of Variation 19
|
2490 nanograms * hour / milliliter
Geometric Coefficient of Variation 19
|
2290 nanograms * hour / milliliter
Geometric Coefficient of Variation 18
|
Adverse Events
LY2886721 Capsule (Water, Fasting)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
LY2886721 ODT (no Water, Fasting)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
LY2886721 ODT (Water, Fed)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
LY2886721 ODT (Water, Fasting)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LY2886721 Capsule (Water, Fasting)
n=26 participants at risk
A single oral dose of 70 milligrams (mg) LY2886721 in a capsule given with water and without a meal in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods.
|
LY2886721 ODT (no Water, Fasting)
n=26 participants at risk
A single oral dose of 70 mg LY2886721 in an orally disintegrating tablet (ODT) given without water and without a meal in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods.
|
LY2886721 ODT (Water, Fed)
n=25 participants at risk
A single oral dose of 70 mg LY2886721 in an ODT given with water and after a high-fat breakfast in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods.
|
LY2886721 ODT (Water, Fasting)
n=24 participants at risk
A single oral dose of 70 mg LY2886721 in an ODT given with water and without a meal in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods.
|
|---|---|---|---|---|
|
Eye disorders
Vision blurred
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/24
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/24
|
|
Gastrointestinal disorders
Nausea
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/24
|
|
Gastrointestinal disorders
Vomiting
|
3.8%
1/26 • Number of events 2
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/24
|
|
General disorders
Application site discolouration
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
4.2%
1/24 • Number of events 1
|
|
General disorders
Application site erythema
|
15.4%
4/26 • Number of events 4
|
7.7%
2/26 • Number of events 2
|
4.0%
1/25 • Number of events 1
|
8.3%
2/24 • Number of events 2
|
|
General disorders
Application site irritation
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/24
|
|
General disorders
Vessel puncture site haemorrhage
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
4.2%
1/24 • Number of events 1
|
|
Infections and infestations
Folliculitis
|
0.00%
0/26
|
7.7%
2/26 • Number of events 2
|
0.00%
0/25
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
4.2%
1/24 • Number of events 1
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Excoriation
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
2/26 • Number of events 2
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
4.2%
1/24 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
4.2%
1/24 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/26
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/24
|
|
Nervous system disorders
Migraine
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/26
|
0.00%
0/26
|
4.0%
1/25 • Number of events 1
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
3.8%
1/26 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
0.00%
0/25
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
4.2%
1/24 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/25
|
4.2%
1/24 • Number of events 1
|
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