Trial Outcomes & Findings for A Study of LY2835219 in Healthy Participants (NCT NCT02256267)
NCT ID: NCT02256267
Last Updated: 2019-01-07
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Period 1: Day 1- Predose,1, 2, 4, 6, 8, 10 hours, Days 2-9: 24, 48, 72, 96, 120, 144, 168, and 192 hours; Period 2: Day 7- Predose,1, 2, 4, 6, 8, 10 hours, Days 8-15: 24, 48, 72, 96, 120, 144, 168, 192 hours
Results posted on
2019-01-07
Participant Flow
This is an open-label, 2-period, fixed-sequence study
Participant milestones
| Measure |
LY2835219 Then LY2835219 + Rifampin
Single oral dose of 200 milligrams (mg) LY2835219 on Day 1 in Period 1. Once daily (QD) doses of 600 mg of Rifampin for 6 days (Day 1 through Day 6) in Period 2.Single oral dose of 200 mg of LY2835219 with 600 mg Rifampin orally, QD on Day 7 in Period 2. QD doses of 600 mg Rifampin was continued for 7 days in Period 2 after coadministration with LY2835219 dose.
|
|---|---|
|
Period 1 (Day 1; Day 2 to Day 9 Washout)
STARTED
|
24
|
|
Period 1 (Day 1; Day 2 to Day 9 Washout)
Received at Least 1 Dose of LY2835219
|
24
|
|
Period 1 (Day 1; Day 2 to Day 9 Washout)
COMPLETED
|
23
|
|
Period 1 (Day 1; Day 2 to Day 9 Washout)
NOT COMPLETED
|
1
|
|
Period 2 (Day 1 to Day 6)
STARTED
|
23
|
|
Period 2 (Day 1 to Day 6)
Received at Least 1 Dose of Rifampin
|
23
|
|
Period 2 (Day 1 to Day 6)
COMPLETED
|
23
|
|
Period 2 (Day 1 to Day 6)
NOT COMPLETED
|
0
|
|
Period 2 (Day 7 to Day 14)
STARTED
|
23
|
|
Period 2 (Day 7 to Day 14)
Received LY2835219 + Rifampin
|
23
|
|
Period 2 (Day 7 to Day 14)
COMPLETED
|
22
|
|
Period 2 (Day 7 to Day 14)
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
LY2835219 Then LY2835219 + Rifampin
Single oral dose of 200 milligrams (mg) LY2835219 on Day 1 in Period 1. Once daily (QD) doses of 600 mg of Rifampin for 6 days (Day 1 through Day 6) in Period 2.Single oral dose of 200 mg of LY2835219 with 600 mg Rifampin orally, QD on Day 7 in Period 2. QD doses of 600 mg Rifampin was continued for 7 days in Period 2 after coadministration with LY2835219 dose.
|
|---|---|
|
Period 1 (Day 1; Day 2 to Day 9 Washout)
Adverse Event
|
1
|
|
Period 2 (Day 7 to Day 14)
Adverse Event
|
1
|
Baseline Characteristics
A Study of LY2835219 in Healthy Participants
Baseline characteristics by cohort
| Measure |
LY2835219 Alone, Then Rifampin, Then LY2835219 + Rifampin
n=24 Participants
Single oral dose of 200 mg LY2835219 on Day 1 in Period 1. Day 2 through Day 9 in Period 1 is washout. QD doses of 600 mg of Rifampin for 6 days (Day 1 through Day 6) in Period 2.
|
|---|---|
|
Age, Continuous
|
58.8 years
STANDARD_DEVIATION 7.4 • n=99 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
24 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Period 1: Day 1- Predose,1, 2, 4, 6, 8, 10 hours, Days 2-9: 24, 48, 72, 96, 120, 144, 168, and 192 hours; Period 2: Day 7- Predose,1, 2, 4, 6, 8, 10 hours, Days 8-15: 24, 48, 72, 96, 120, 144, 168, 192 hoursPopulation: All participants who received at least 1 dose of study drug and have evaluable PK data.
Outcome measures
| Measure |
200 mg LY2835219
n=24 Participants
Single oral dose of 200 mg LY2835219
|
200 mg LY2835219 + 600 mg Rifampin
n=21 Participants
Single oral dose of 200 mg of LY2835219 with 600 mg rifampin orally, QD for 14 days
|
|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2835219
|
134 nanogram per milliliter (ng/ml)
Geometric Coefficient of Variation 45
|
10.5 nanogram per milliliter (ng/ml)
Geometric Coefficient of Variation 58
|
PRIMARY outcome
Timeframe: Period 1: Day 1- Predose,1, 2, 4, 6, 8, 10 hours, Days 2-9: 24, 48, 72, 96, 120, 144, 168, and 192 hours; Period 2: Day 7- Predose,1, 2, 4, 6, 8, 10 hours, Days 8-15: 24, 48, 72, 96, 120, 144, 168, 192 hoursPopulation: All participants who received at least 1 dose of study drug and have evaluable PK data.
Outcome measures
| Measure |
200 mg LY2835219
n=24 Participants
Single oral dose of 200 mg LY2835219
|
200 mg LY2835219 + 600 mg Rifampin
n=14 Participants
Single oral dose of 200 mg of LY2835219 with 600 mg rifampin orally, QD for 14 days
|
|---|---|---|
|
PK: Area Under the Concentration Time Curve AUC(0-∞) of LY2835219
|
4570 nanogram x hour per mL (ng x h/mL)
Geometric Coefficient of Variation 53
|
229 nanogram x hour per mL (ng x h/mL)
Geometric Coefficient of Variation 48
|
Adverse Events
LY2835219
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Rifampin
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
LY2835219 + Rifampin
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LY2835219
n=24 participants at risk
Single oral dose of 200 mg LY2835219 Day 1, period 1.
|
Rifampin
n=23 participants at risk
Single oral, QD doses of 600 mg of Rifampin for 6 days Day 1 to Day 6 in period 2
|
LY2835219 + Rifampin
n=23 participants at risk
Single oral dose of 200 mg of LY2835219 with 600 mg rifampin orally, QD on Day 7 of period 2.
|
|---|---|---|---|
|
Nervous system disorders
Syncope
|
0.00%
0/24
|
0.00%
0/23
|
4.3%
1/23 • Number of events 1
|
Other adverse events
| Measure |
LY2835219
n=24 participants at risk
Single oral dose of 200 mg LY2835219 Day 1, period 1.
|
Rifampin
n=23 participants at risk
Single oral, QD doses of 600 mg of Rifampin for 6 days Day 1 to Day 6 in period 2
|
LY2835219 + Rifampin
n=23 participants at risk
Single oral dose of 200 mg of LY2835219 with 600 mg rifampin orally, QD on Day 7 of period 2.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
2/24 • Number of events 2
|
4.3%
1/23 • Number of events 1
|
0.00%
0/23
|
|
Gastrointestinal disorders
Nausea
|
4.2%
1/24 • Number of events 2
|
4.3%
1/23 • Number of events 1
|
13.0%
3/23 • Number of events 3
|
|
Infections and infestations
Upper respiratory tract infection
|
12.5%
3/24 • Number of events 3
|
4.3%
1/23 • Number of events 1
|
0.00%
0/23
|
|
Nervous system disorders
Headache
|
4.2%
1/24 • Number of events 1
|
0.00%
0/23
|
8.7%
2/23 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
2/24 • Number of events 2
|
0.00%
0/23
|
0.00%
0/23
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Research Organization (CRO) and its third party contractors shall not publish, discuss or release data emanating from a Study without Lilly's express written permission.
- Publication restrictions are in place
Restriction type: OTHER