Trial Outcomes & Findings for A Study to Compare the Concentrations of LY2189265 After Different Methods of Administration to Healthy Volunteers. (NCT NCT01301092)
NCT ID: NCT01301092
Last Updated: 2014-10-07
Results Overview
AUC is AUC from time zero to infinity. The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
Predose up to 336 hours postdose
Results posted on
2014-10-07
Participant Flow
Participant milestones
| Measure |
Part A: LY2189265 Intravenous
Single 0.1-milligram (mg) intravenous (IV) dose of LY2189265.
|
Part B: LY2189265 Subcutaneous, Intravenous
Participants were randomized to 2 sequences of 2 treatments. Single 1.5-mg subcutaneous (SC) dose of LY2189265 in Period 1; single 0.1-mg intravenous (IV) dose of LY2189265 in Period 2 or vice versa. There was a washout period of at least 4 weeks between dosing periods.
|
Part C: LY2189265 Subcutaneous, Intramuscular
Participants were randomized to 2 sequences of 2 treatments. Single 0.75-mg subcutaneous (SC) dose of LY2189265 in Period 1; single 0.75-mg intramuscular (IM) of LY2189265 in Period 2 or vice versa. There was a washout period of at least 4 weeks between dosing periods.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
16
|
8
|
|
Overall Study
COMPLETED
|
6
|
16
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Part A: LY2189265 Intravenous
Single 0.1-milligram (mg) intravenous (IV) dose of LY2189265.
|
Part B: LY2189265 Subcutaneous, Intravenous
Participants were randomized to 2 sequences of 2 treatments. Single 1.5-mg subcutaneous (SC) dose of LY2189265 in Period 1; single 0.1-mg intravenous (IV) dose of LY2189265 in Period 2 or vice versa. There was a washout period of at least 4 weeks between dosing periods.
|
Part C: LY2189265 Subcutaneous, Intramuscular
Participants were randomized to 2 sequences of 2 treatments. Single 0.75-mg subcutaneous (SC) dose of LY2189265 in Period 1; single 0.75-mg intramuscular (IM) of LY2189265 in Period 2 or vice versa. There was a washout period of at least 4 weeks between dosing periods.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Compare the Concentrations of LY2189265 After Different Methods of Administration to Healthy Volunteers.
Baseline characteristics by cohort
| Measure |
Part A: LY2189265 Intravenous
n=6 Participants
Single 0.1 milligram (mg) intravenous (IV) dose of LY2189265
|
Part B: LY2189265 Subcutaneous, Intravenous
n=16 Participants
Participants were randomized to 2 sequences of 2 treatments. Single 1.5-mg subcutaneous (SC) dose of LY2189265 in Period 1; single 0.1-mg intravenous (IV) dose of LY2189265 in Period 2 or vice versa. There was a washout period of at least 4 weeks between dosing periods
|
Part C: LY2189265 Subcutaneous, Intramuscular
n=8 Participants
Participants were randomized to 2 sequences of 2 treatments. Single 0.75-mg subcutaneous (SC) dose of LY2189265 in Period 1; single 0.75-mg intramuscular (IM) of LY2189265 in Period 2 or vice versa. There was a washout period of at least 4 weeks between dosing periods
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
47.0 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
42.3 years
STANDARD_DEVIATION 15.0 • n=7 Participants
|
45.6 years
STANDARD_DEVIATION 16.6 • n=5 Participants
|
44.10 years
STANDARD_DEVIATION 14.71 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
16 participants
n=7 Participants
|
8 participants
n=5 Participants
|
30 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Predose up to 336 hours postdosePopulation: Participants in Part B who had pharmacokinetic (PK) data.
AUC is AUC from time zero to infinity. The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error.
Outcome measures
| Measure |
Part B: LY2189265 Subcutaneous
n=16 Participants
Single 1.5 mg-subcutaneous (SC) dose of LY2189265 in Period 1 or 2
|
Part B: LY2189265 Intravenous
n=16 Participants
Single 0.1-mg intravenous (IV) dose of LY2189265 in Period 1 or 2
|
|---|---|---|
|
Dose Normalized Area Under the Concentration Time Curve (AUC) of LY2189265: Subcutaneous (SC) to Intravenous (IV)
|
10256 nanograms*hour/milliliter/milligram
Interval 8964.0 to 11734.0
|
23150 nanograms*hour/milliliter/milligram
Interval 20234.0 to 26485.0
|
PRIMARY outcome
Timeframe: Predose up to 336 hours postdosePopulation: Participants in Part B who had pharmacokinetic (PK) data.
The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error.
Outcome measures
| Measure |
Part B: LY2189265 Subcutaneous
n=16 Participants
Single 1.5 mg-subcutaneous (SC) dose of LY2189265 in Period 1 or 2
|
Part B: LY2189265 Intravenous
n=16 Participants
Single 0.1-mg intravenous (IV) dose of LY2189265 in Period 1 or 2
|
|---|---|---|
|
Maximum Concentration (Cmax) of LY2189265: Subcutaneous (SC) to Intravenous (IV)
|
80.7 nanograms/milliliter (ng/mL)
Interval 71.8 to 90.8
|
38.3 nanograms/milliliter (ng/mL)
Interval 34.1 to 43.1
|
SECONDARY outcome
Timeframe: Predose up to 336 hours postdosePopulation: Participants in Part C who had pharmacokinetic (PK) data.
AUC is AUC from time zero to infinity. The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error.
Outcome measures
| Measure |
Part B: LY2189265 Subcutaneous
n=7 Participants
Single 1.5 mg-subcutaneous (SC) dose of LY2189265 in Period 1 or 2
|
Part B: LY2189265 Intravenous
n=8 Participants
Single 0.1-mg intravenous (IV) dose of LY2189265 in Period 1 or 2
|
|---|---|---|
|
Area Under the Concentration Time Curve (AUC) of LY2189265: Intramuscular (IM) to Subcutaneous (SC)
|
9828 nanograms*hour/milliliter (ng*h/mL)
Interval 7525.0 to 12837.0
|
10215 nanograms*hour/milliliter (ng*h/mL)
Interval 7832.0 to 13323.0
|
SECONDARY outcome
Timeframe: Predose up to 336 hours postdosePopulation: Participants in Part C who had pharmacokinetic (PK) data.
The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error.
Outcome measures
| Measure |
Part B: LY2189265 Subcutaneous
n=7 Participants
Single 1.5 mg-subcutaneous (SC) dose of LY2189265 in Period 1 or 2
|
Part B: LY2189265 Intravenous
n=8 Participants
Single 0.1-mg intravenous (IV) dose of LY2189265 in Period 1 or 2
|
|---|---|---|
|
)Maximum Concentration (Cmax) of LY2189265: Intramuscular (IM) to Subcutaneous (SC)
|
56.9 nanograms/milliliter (ng/mL)
Interval 48.4 to 67.0
|
54.2 nanograms/milliliter (ng/mL)
Interval 46.3 to 63.5
|
Adverse Events
Part A: 0.1 mg IV LY2189265
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part B: 0.1 mg IV LY2189265
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Part B: 1.5 mg SC LY2189265
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Part C: 0.75 mg IM LY2189265
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part C: 0.75 mg SC LY2189265
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 |
Part A: 0.1 mg IV LY2189265
n=6 participants at risk
Single 0.1-milligram (mg) intravenous (IV) dose of LY2189265
|
Part B: 0.1 mg IV LY2189265
n=16 participants at risk
Single 0.1-mg intravenous (IV) dose of LY2189265 in Period 1 or 2.
|
Part B: 1.5 mg SC LY2189265
n=16 participants at risk
Single 1.5-mg subcutaneous (SC) dose of LY2189265 in Period 1 or 2.
|
Part C: 0.75 mg IM LY2189265
n=8 participants at risk
Single 0.75-mg intramuscular (IM) of LY2189265 in Period 1 or 2.
|
Part C: 0.75 mg SC LY2189265
n=8 participants at risk
Single 0.75-mg subcutaneous (SC) dose of LY2189265 in Period 1 or 2.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6
|
0.00%
0/16
|
6.2%
1/16 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6
|
0.00%
0/16
|
18.8%
3/16 • Number of events 3
|
0.00%
0/8
|
25.0%
2/8 • Number of events 2
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6
|
0.00%
0/16
|
6.2%
1/16 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6
|
6.2%
1/16 • Number of events 1
|
12.5%
2/16 • Number of events 2
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6
|
0.00%
0/16
|
6.2%
1/16 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6
|
0.00%
0/16
|
6.2%
1/16 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Application site erythema
|
0.00%
0/6
|
6.2%
1/16 • Number of events 1
|
0.00%
0/16
|
0.00%
0/8
|
0.00%
0/8
|
|
General disorders
Extravasation
|
0.00%
0/6
|
6.2%
1/16 • Number of events 1
|
0.00%
0/16
|
0.00%
0/8
|
0.00%
0/8
|
|
General disorders
Oedema
|
0.00%
0/6
|
6.2%
1/16 • Number of events 1
|
0.00%
0/16
|
0.00%
0/8
|
0.00%
0/8
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/6
|
6.2%
1/16 • Number of events 1
|
0.00%
0/16
|
0.00%
0/8
|
0.00%
0/8
|
|
Infections and infestations
Candidiasis
|
0.00%
0/6
|
6.2%
1/16 • Number of events 1
|
0.00%
0/16
|
0.00%
0/8
|
0.00%
0/8
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
0.00%
0/6
|
6.2%
1/16 • Number of events 1
|
0.00%
0/16
|
0.00%
0/8
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6
|
0.00%
0/16
|
18.8%
3/16 • Number of events 3
|
0.00%
0/8
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6
|
0.00%
0/16
|
6.2%
1/16 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6
|
0.00%
0/16
|
0.00%
0/16
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6
|
0.00%
0/16
|
0.00%
0/16
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/6
|
0.00%
0/16
|
6.2%
1/16 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
|
Nervous system disorders
Headache
|
0.00%
0/6
|
12.5%
2/16 • Number of events 2
|
37.5%
6/16 • Number of events 7
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/6
|
6.2%
1/16 • Number of events 1
|
0.00%
0/16
|
0.00%
0/8
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6
|
0.00%
0/16
|
0.00%
0/16
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/6
|
0.00%
0/16
|
6.2%
1/16 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/6
|
6.2%
1/16 • Number of events 1
|
0.00%
0/16
|
0.00%
0/8
|
0.00%
0/8
|
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