Trial Outcomes & Findings for A Study of Treprostinil and a New Formulation of LY900014 in Healthy Japanese Participants (NCT NCT02770521)
NCT ID: NCT02770521
Last Updated: 2020-06-04
Results Overview
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, are reported in the Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
23 participants
Primary outcome timeframe
Part A: Baseline through Study Completion (up to 14 Days after Last Dose)
Results posted on
2020-06-04
Participant Flow
This study had two parts: Part A was a two-period crossover. Part B was a three-period crossover with dose escalation. Healthy Japanese participants were eligible to enroll in one part. One randomized participant discontinued prior to study completion and was replaced. The replacement adopted the original participant's randomization scheme.
Participant milestones
| Measure |
Placebo/Treprostinil (Part A)
Placebo given subcutaneously (SC) once in first study period. 1,000 nanograms (ng) of treprostinil given SC once in second study period. There was a minimum three day washout between doses.
|
Treprostinil/Placebo (Part A)
1,000 ng of treprostinil given SC once in first study period. Matching placebo given SC once in second study period. There was a minimum three day washout between doses.
|
15 U Insulin Lispro/15 U LY900014/30 U LY900014 (Part B)
15 units (U) insulin lispro given SC once in first study period. 15 U LY900014 given SC once in second study period. 30 U LY900014 given SC once in third study period. There was a minimum three day washout between doses.
|
7.5 U LY900014/15 U Insulin Lispro/30 U LY900014 (Part B)
7.5 U LY900014 given SC once in first study period. 15 U insulin lispro given SC once in second study period. 30 U LY900014 given SC once in third study period. There was a minimum three day washout between doses.
|
7.5 U LY900014/15 U LY900014/15 U Insulin Lispro (Part B)
7.5 U LY900014 given SC once in first study period. 15 U LY900014 given SC once in second study period. 15 U insulin lispro given SC once in third study period. There was a minimum three day washout between doses.
|
7.5 U LY900014/15 U LY900014/30 U LY900014 (Part B)
7.5 U LY900014 given SC once in first study period. 15 U LY900014 given SC once in second study period. 30 U LY900014 given SC once in third study period. There was a minimum three day washout between doses.
|
|---|---|---|---|---|---|---|
|
Period One
STARTED
|
4
|
4
|
2
|
2
|
2
|
9
|
|
Period One
Received Study Drug
|
4
|
4
|
2
|
2
|
2
|
9
|
|
Period One
COMPLETED
|
4
|
4
|
2
|
2
|
2
|
9
|
|
Period One
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period Two
STARTED
|
4
|
4
|
2
|
2
|
2
|
9
|
|
Period Two
Received Study Drug
|
4
|
4
|
2
|
2
|
2
|
9
|
|
Period Two
COMPLETED
|
4
|
4
|
2
|
2
|
2
|
9
|
|
Period Two
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period Three
STARTED
|
0
|
0
|
2
|
2
|
2
|
9
|
|
Period Three
Received Study Drug
|
0
|
0
|
2
|
2
|
2
|
9
|
|
Period Three
COMPLETED
|
0
|
0
|
2
|
2
|
2
|
9
|
|
Period Three
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Treprostinil and a New Formulation of LY900014 in Healthy Japanese Participants
Baseline characteristics by cohort
| Measure |
Treprostinil or Placebo (Part A)
n=8 Participants
Participants received either 1000 ng of treprostinil or matching placebo as a SC injection once in each of two study periods.
|
LY900014 or Insulin Lispro (Part B)
n=15 Participants
Participants received each of three doses of LY900014 (7.5 U, 15 U, 30 U) or 15 U of insulin lispro as a SC injection once in each of three study periods.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.3 years
STANDARD_DEVIATION 4.4 • n=93 Participants
|
26.1 years
STANDARD_DEVIATION 5.4 • n=4 Participants
|
26.2 years
STANDARD_DEVIATION 5.0 • n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
Japan
|
8 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Body Mass Index (BMI)
|
22.57 kilograms per meter squared (kg/m²)
STANDARD_DEVIATION 2.00 • n=93 Participants
|
21.93 kilograms per meter squared (kg/m²)
STANDARD_DEVIATION 2.19 • n=4 Participants
|
22.15 kilograms per meter squared (kg/m²)
STANDARD_DEVIATION 2.10 • n=27 Participants
|
PRIMARY outcome
Timeframe: Part A: Baseline through Study Completion (up to 14 Days after Last Dose)Population: All participants who received at least one dose of study drug.
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, are reported in the Adverse Events module.
Outcome measures
| Measure |
Placebo (Part A)
n=8 Participants
Placebo given subcutaneously (SC) once in one of two study periods. There was a minimum three day washout between doses.
|
Treprostinil (Part A)
n=8 Participants
1,000 ng of treprostinil given SC once in one of two study periods. There was a minimum three day washout between doses.
|
15 U Insulin Lispro (Part B)
n=6 Participants
15 units (U) insulin lispro given SC once in up to one of three study periods. There was a minimum three day washout between doses.
|
7.5 U LY900014 (Part B)
n=13 Participants
7.5 U LY900014 given SC once in up to one of three study periods. There was a minimum three day washout between doses.
|
15 U LY900014 (Part B)
n=13 Participants
15 U LY900014 given SC once in up to one of three study periods. There was a minimum three day washout between doses.
|
30 U LY900014 (Part B)
n=13 Participants
30 ULY900014 given SC once in up to one of three study periods. There was a minimum three day washout between doses.
|
|---|---|---|---|---|---|---|
|
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 Minutes PostdosePopulation: All participants who received at least one dose of study drug LY900014 in Part B and had evaluable pharmacokinetic data. Per protocol, PK in Part B was not analyzed for 15 U Insulin Lispro (Humalog). This arm was included for only safety analysis.
PK: Insulin Lispro Cmax (Part B)
Outcome measures
| Measure |
Placebo (Part A)
n=13 Participants
Placebo given subcutaneously (SC) once in one of two study periods. There was a minimum three day washout between doses.
|
Treprostinil (Part A)
n=13 Participants
1,000 ng of treprostinil given SC once in one of two study periods. There was a minimum three day washout between doses.
|
15 U Insulin Lispro (Part B)
n=13 Participants
15 units (U) insulin lispro given SC once in up to one of three study periods. There was a minimum three day washout between doses.
|
7.5 U LY900014 (Part B)
7.5 U LY900014 given SC once in up to one of three study periods. There was a minimum three day washout between doses.
|
15 U LY900014 (Part B)
15 U LY900014 given SC once in up to one of three study periods. There was a minimum three day washout between doses.
|
30 U LY900014 (Part B)
30 ULY900014 given SC once in up to one of three study periods. There was a minimum three day washout between doses.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Insulin Lispro Maximum Concentration (Cmax) (Part B)
|
582 picomoles/liter (pmol/L)
Geometric Coefficient of Variation 42
|
956 picomoles/liter (pmol/L)
Geometric Coefficient of Variation 41
|
2170 picomoles/liter (pmol/L)
Geometric Coefficient of Variation 30
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 Minutes PostdosePopulation: All participants who received at least one dose of study drug LY900014 in Part B and had evaluable pharmacokinetic data. Per protocol, PK in Part B was not analyzed for 15 U Insulin Lispro (Humalog). This arm was included for only safety analysis.
PK: Insulin Lispro AUC(0-30min) (Part B)
Outcome measures
| Measure |
Placebo (Part A)
n=13 Participants
Placebo given subcutaneously (SC) once in one of two study periods. There was a minimum three day washout between doses.
|
Treprostinil (Part A)
n=13 Participants
1,000 ng of treprostinil given SC once in one of two study periods. There was a minimum three day washout between doses.
|
15 U Insulin Lispro (Part B)
n=13 Participants
15 units (U) insulin lispro given SC once in up to one of three study periods. There was a minimum three day washout between doses.
|
7.5 U LY900014 (Part B)
7.5 U LY900014 given SC once in up to one of three study periods. There was a minimum three day washout between doses.
|
15 U LY900014 (Part B)
15 U LY900014 given SC once in up to one of three study periods. There was a minimum three day washout between doses.
|
30 U LY900014 (Part B)
30 ULY900014 given SC once in up to one of three study periods. There was a minimum three day washout between doses.
|
|---|---|---|---|---|---|---|
|
PK: Insulin Lispro Area Under the Concentration-Time Curve From Time Zero to 30 Minutes (AUC[0-30min]) (Part B)
|
174 pmol*hour/L (pmol*hr/L)
Geometric Coefficient of Variation 57
|
273 pmol*hour/L (pmol*hr/L)
Geometric Coefficient of Variation 51
|
585 pmol*hour/L (pmol*hr/L)
Geometric Coefficient of Variation 31
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 15, 30, 60 and 120 Minutes PostdosePopulation: All participants in Part A who received study drug and had evaluable pharmacokinetic data.
PK: Treprostinil Tmax (Part A)
Outcome measures
| Measure |
Placebo (Part A)
n=8 Participants
Placebo given subcutaneously (SC) once in one of two study periods. There was a minimum three day washout between doses.
|
Treprostinil (Part A)
1,000 ng of treprostinil given SC once in one of two study periods. There was a minimum three day washout between doses.
|
15 U Insulin Lispro (Part B)
15 units (U) insulin lispro given SC once in up to one of three study periods. There was a minimum three day washout between doses.
|
7.5 U LY900014 (Part B)
7.5 U LY900014 given SC once in up to one of three study periods. There was a minimum three day washout between doses.
|
15 U LY900014 (Part B)
15 U LY900014 given SC once in up to one of three study periods. There was a minimum three day washout between doses.
|
30 U LY900014 (Part B)
30 ULY900014 given SC once in up to one of three study periods. There was a minimum three day washout between doses.
|
|---|---|---|---|---|---|---|
|
PK: Treprostinil Time to Maximum Concentration (Tmax) (Part A)
|
0.25 hours
Interval 0.25 to 0.5
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 15, 30, 60 and 120 Minutes PostdosePopulation: All participants in Part A who received study drug and had evaluable pharmacokinetic data.
PK: Cmax of Treprostinil (Part A)
Outcome measures
| Measure |
Placebo (Part A)
n=8 Participants
Placebo given subcutaneously (SC) once in one of two study periods. There was a minimum three day washout between doses.
|
Treprostinil (Part A)
1,000 ng of treprostinil given SC once in one of two study periods. There was a minimum three day washout between doses.
|
15 U Insulin Lispro (Part B)
15 units (U) insulin lispro given SC once in up to one of three study periods. There was a minimum three day washout between doses.
|
7.5 U LY900014 (Part B)
7.5 U LY900014 given SC once in up to one of three study periods. There was a minimum three day washout between doses.
|
15 U LY900014 (Part B)
15 U LY900014 given SC once in up to one of three study periods. There was a minimum three day washout between doses.
|
30 U LY900014 (Part B)
30 ULY900014 given SC once in up to one of three study periods. There was a minimum three day washout between doses.
|
|---|---|---|---|---|---|---|
|
PK: Maximum Concentration (Cmax) of Treprostinil (Part A)
|
0.0271 ng/milliliter (mL)
Geometric Coefficient of Variation 36
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Placebo (Part A)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treprostinil (Part A)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
15 U Insulin Lispro (Part B)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
7.5 U LY900014 (Part B)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
15 U LY900014 (Part B)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
30 U LY900014 (Part B)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo (Part A)
n=8 participants at risk
Placebo given subcutaneously (SC) once in one of two study periods. There was a minimum three day washout between doses.
|
Treprostinil (Part A)
n=8 participants at risk
1,000 ng of treprostinil given SC once in one of two study periods. There was a minimum three day washout between doses.
|
15 U Insulin Lispro (Part B)
n=6 participants at risk
15 units (U) insulin lispro given SC once in up to one of three study periods. There was a minimum three day washout between doses.
|
7.5 U LY900014 (Part B)
n=13 participants at risk
7.5 U LY900014 given SC once in up to one of three study periods. There was a minimum three day washout between doses.
|
15 U LY900014 (Part B)
n=13 participants at risk
15 U LY900014 given SC once in up to one of three study periods. There was a minimum three day washout between doses.
|
30 U LY900014 (Part B)
n=13 participants at risk
30 ULY900014 given SC once in up to one of three study periods. There was a minimum three day washout between doses.
|
|---|---|---|---|---|---|---|
|
General disorders
Infusion site phlebitis
|
0.00%
0/8 • Baseline through Study Completion (up to 14 Days after Last Dose)
All participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through Study Completion (up to 14 Days after Last Dose)
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline through Study Completion (up to 14 Days after Last Dose)
All participants who received at least one dose of study drug.
|
0.00%
0/13 • Baseline through Study Completion (up to 14 Days after Last Dose)
All participants who received at least one dose of study drug.
|
15.4%
2/13 • Number of events 2 • Baseline through Study Completion (up to 14 Days after Last Dose)
All participants who received at least one dose of study drug.
|
7.7%
1/13 • Number of events 1 • Baseline through Study Completion (up to 14 Days after Last Dose)
All participants who received at least one dose of study drug.
|
|
General disorders
Injection site erythema
|
0.00%
0/8 • Baseline through Study Completion (up to 14 Days after Last Dose)
All participants who received at least one dose of study drug.
|
62.5%
5/8 • Number of events 5 • Baseline through Study Completion (up to 14 Days after Last Dose)
All participants who received at least one dose of study drug.
|
50.0%
3/6 • Number of events 3 • Baseline through Study Completion (up to 14 Days after Last Dose)
All participants who received at least one dose of study drug.
|
53.8%
7/13 • Number of events 7 • Baseline through Study Completion (up to 14 Days after Last Dose)
All participants who received at least one dose of study drug.
|
46.2%
6/13 • Number of events 6 • Baseline through Study Completion (up to 14 Days after Last Dose)
All participants who received at least one dose of study drug.
|
7.7%
1/13 • Number of events 1 • Baseline through Study Completion (up to 14 Days after Last Dose)
All participants who received at least one dose of study drug.
|
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