Trial Outcomes & Findings for A Study of LY2835219 in Healthy Participants (NCT NCT02327143)
NCT ID: NCT02327143
Last Updated: 2018-08-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
11 participants
Primary outcome timeframe
Predose, 2, 4, 6, 6.25, 6.5, 6.75, 7.25, 8.25,10, 12, 14, 24, 48, 72, 96,120, 144, 168,192 Hours Postdose
Results posted on
2018-08-06
Participant Flow
This is a single arm study. Participants first received 200 mg LY2835219 and then 0.4 mg ¹³C₈-LY2835219 given 6 hours later.
Participant milestones
| Measure |
200 mg LY2835219
200 mg LY2835219 administered orally on day 1.
|
200 mg LY2835219 + 0.4 mg ¹³C₈-LY2835219
0.4 mg ¹³C₈-LY2835219 given intravenously (IV) for 15 minutes, starting approximately 6 hours after the oral dose on day 1.
|
|---|---|---|
|
Day 1: Time 0 Hrs to 6 Hrs
STARTED
|
11
|
0
|
|
Day 1: Time 0 Hrs to 6 Hrs
COMPLETED
|
11
|
0
|
|
Day 1: Time 0 Hrs to 6 Hrs
NOT COMPLETED
|
0
|
0
|
|
Day 1: Time 6 Hrs - to Day 9
STARTED
|
0
|
11
|
|
Day 1: Time 6 Hrs - to Day 9
COMPLETED
|
0
|
11
|
|
Day 1: Time 6 Hrs - to Day 9
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of LY2835219 in Healthy Participants
Baseline characteristics by cohort
| Measure |
All Participants
n=11 Participants
200 mg LY2835219 administered orally on day 1. 0.4 mg ¹³C₈-LY2835219 given intravenously (IV) for 15 minutes, starting approximately 6 hours after the oral dose on day 1.
|
|---|---|
|
Age, Continuous
|
56.00 years
STANDARD_DEVIATION 8.00 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 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 Kingdom
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Predose, 2, 4, 6, 6.25, 6.5, 6.75, 7.25, 8.25,10, 12, 14, 24, 48, 72, 96,120, 144, 168,192 Hours PostdosePopulation: All participants who received at least 1 dose of study drug and had evaluable PK data
Outcome measures
| Measure |
200 mg LY2835219
n=8 Participants
200 mg LY2835219 administered orally on day 1.
|
200 mg LY2835219 + 0.4 mg ¹³C₈-LY2835219
n=8 Participants
0.4 mg ¹³C₈-LY2835219 given intravenously (IV) for 15 minutes, starting approximately 6 hours after the oral dose.
|
|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Zero to Infinity [AUC(0-∞)] of LY2835219 and ¹³C₈-LY2835219
|
3730 nanogram*h/milliliter (ng∙h/mL)
Geometric Coefficient of Variation 31
|
15.4 nanogram*h/milliliter (ng∙h/mL)
Geometric Coefficient of Variation 28
|
SECONDARY outcome
Timeframe: Predose, 2, 4, 6, 6.25, 6.5, 6.75, 7.25, 8.25,10, 12, 14, 24, 48, 72, 96,120, 144, 168,192 Hours PostdosePopulation: All participants who received at least 1 dose of study drug and had evaluable PK data.
Outcome measures
| Measure |
200 mg LY2835219
n=8 Participants
200 mg LY2835219 administered orally on day 1.
|
200 mg LY2835219 + 0.4 mg ¹³C₈-LY2835219
0.4 mg ¹³C₈-LY2835219 given intravenously (IV) for 15 minutes, starting approximately 6 hours after the oral dose.
|
|---|---|---|
|
PK: Maximum Observed Concentration (Cmax) of LY2835219
|
114 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 32
|
—
|
SECONDARY outcome
Timeframe: Predose, 2, 4, 6, 6.25, 6.5, 6.75, 7.25, 8.25,10, 12, 14, 24, 48, 72, 96,120, 144, 168,192 Hours PostdosePopulation: All participants who received at least 1 dose of study drug and had evaluable PK data
Outcome measures
| Measure |
200 mg LY2835219
n=8 Participants
200 mg LY2835219 administered orally on day 1.
|
200 mg LY2835219 + 0.4 mg ¹³C₈-LY2835219
0.4 mg ¹³C₈-LY2835219 given intravenously (IV) for 15 minutes, starting approximately 6 hours after the oral dose.
|
|---|---|---|
|
PK: Time of Maximum Observed Drug Concentration (Tmax) of LY2835219
|
6.63 hours
Interval 6.5 to 8.25
|
—
|
Adverse Events
200 mg LY2835219
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
200 mg LY2835219 + 0.4 mg ¹³C₈-LY2835219
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
200 mg LY2835219
n=11 participants at risk
200 mg LY2835219 administered orally on day 1.
|
200 mg LY2835219 + 0.4 mg ¹³C₈-LY2835219
n=11 participants at risk
0.4 mg ¹³C₈-LY2835219 given intravenously (IV) for 15 minutes, starting approximately 6 hours after the oral dose.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/11
|
27.3%
3/11 • Number of events 3
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11 • Number of events 1
|
18.2%
2/11 • Number of events 2
|
|
General disorders
Feeling cold
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
|
Nervous system disorders
Dizziness
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
|
Nervous system disorders
Headache
|
18.2%
2/11 • Number of events 2
|
9.1%
1/11 • 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