Trial Outcomes & Findings for A Study to Evaluate the Effect of Food on LY2216684 (NCT NCT01389765)
NCT ID: NCT01389765
Last Updated: 2018-11-13
Results Overview
The AUC for LY2216684 was calculated for LY2216684 administered in fed state (test) and LY2216684 administered in fasted state (reference). Geometric Least Squares (LS) means were calculated according to the following model: Log(PK) = sequence + period + treatment + subject + random error for AUC.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 24, 48, 72 hours post dose
Results posted on
2018-11-13
Participant Flow
Participant milestones
| Measure |
LY2216684 During Fed, Then LY2216684 During Fasting State
In Period 1, participants received a single oral dose of 18 milligram (mg) LY2216684, administered in fed state. In Period 2, participants received a single oral dose of 18 mg LY2216684, administered in the fasting state. Periods were separated by a 7-day washout period.
|
LY2216684 During Fasting, Then LY2216684 During Fed State
In Period 1, participants received a single oral dose of 18 milligram (mg) LY2216684, administered in fasting state. In Period 2, participants received a single oral dose of 18 mg LY2216684, administered in the fed state. Periods were separated by a 7-day washout period.
|
|---|---|---|
|
First Intervention (Day 1)
STARTED
|
12
|
12
|
|
First Intervention (Day 1)
COMPLETED
|
12
|
12
|
|
First Intervention (Day 1)
NOT COMPLETED
|
0
|
0
|
|
Washout Period (7 Days)
STARTED
|
12
|
12
|
|
Washout Period (7 Days)
COMPLETED
|
12
|
12
|
|
Washout Period (7 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (Day 1)
STARTED
|
12
|
12
|
|
Second Intervention (Day 1)
COMPLETED
|
12
|
12
|
|
Second Intervention (Day 1)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Effect of Food on LY2216684
Baseline characteristics by cohort
| Measure |
Overall
n=24 Participants
In Period 1, participants received a single oral dose of 18 milligram (mg) LY2216684, administered in either fasted or fed state. In Period 2, participants received a single oral dose of 18 mg LY2216684, administered in the alternative feeding state that was not used during Period 1 (fasted or fed). Periods were separated by a 7-day washout period.
|
|---|---|
|
Age, Continuous
|
39.0 years
STANDARD_DEVIATION 12.8 • n=93 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
24 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 24, 48, 72 hours post dosePopulation: All participants with a baseline observation and at least 1 post-baseline observation.
The AUC for LY2216684 was calculated for LY2216684 administered in fed state (test) and LY2216684 administered in fasted state (reference). Geometric Least Squares (LS) means were calculated according to the following model: Log(PK) = sequence + period + treatment + subject + random error for AUC.
Outcome measures
| Measure |
LY2216684 Administered in Fed State
n=24 Participants
Participants received a single oral dose of 18 mg LY2216684 in fed state.
|
LY2216684 Administered in Fasted State
n=24 Participants
Participants received a single oral dose of 18 mg LY2216684 in fasted state.
|
|---|---|---|
|
Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-∞) of LY2216684
|
871 nanogram*hour/milliliter (ng*h/mL)
Interval 779.0 to 973.0
|
861 nanogram*hour/milliliter (ng*h/mL)
Interval 771.0 to 962.0
|
PRIMARY outcome
Timeframe: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 24, 48, 72 hours post dosePopulation: All participants with a baseline observation and at least 1 post-baseline observation.
The Cmax for LY2216684 was calculated for LY2216684 administered in fed state (test) and LY2216684 administered in fasted state (reference). Geometric LS means were calculated according to the following model: Log(PK) = sequence + period + treatment + subject + random error for Cmax.
Outcome measures
| Measure |
LY2216684 Administered in Fed State
n=24 Participants
Participants received a single oral dose of 18 mg LY2216684 in fed state.
|
LY2216684 Administered in Fasted State
n=24 Participants
Participants received a single oral dose of 18 mg LY2216684 in fasted state.
|
|---|---|---|
|
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY2216684
|
66.04 nanogram/milliliter (ng/mL)
Interval 59.85 to 72.88
|
68.68 nanogram/milliliter (ng/mL)
Interval 62.24 to 75.78
|
PRIMARY outcome
Timeframe: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 24, 48, 72 hours post dosePopulation: All participants with a baseline observation and at least 1 post-baseline observation.
Outcome measures
| Measure |
LY2216684 Administered in Fed State
n=24 Participants
Participants received a single oral dose of 18 mg LY2216684 in fed state.
|
LY2216684 Administered in Fasted State
n=24 Participants
Participants received a single oral dose of 18 mg LY2216684 in fasted state.
|
|---|---|---|
|
Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) of LY2216684
|
3.00 hours
Interval 1.0 to 6.0
|
2.00 hours
Interval 1.0 to 3.0
|
Adverse Events
LY2216684 Administered in Fed State
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
LY2216684 Administered in Fasted State
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LY2216684 Administered in Fed State
n=24 participants at risk
Participants received a single oral dose of 18 mg LY2216684 in fed state.
|
LY2216684 Administered in Fasted State
n=24 participants at risk
Participants received a single oral dose of 18 mg LY2216684 in fasted state.
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
|
Gastrointestinal disorders
Abdominal pain
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/24
|
8.3%
2/24 • Number of events 2
|
|
General disorders
Asthenia
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
|
General disorders
Fatigue
|
4.2%
1/24 • Number of events 1
|
8.3%
2/24 • Number of events 2
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
4.2%
1/24 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
|
Nervous system disorders
Headache
|
12.5%
3/24 • Number of events 3
|
0.00%
0/24
|
|
Renal and urinary disorders
Pollakiuria
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
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