Trial Outcomes & Findings for A Study to Compare Two Forms of LY2608204 in Healthy People (NCT NCT01313286)
NCT ID: NCT01313286
Last Updated: 2018-10-05
Results Overview
Area under the concentration versus time curve from zero to infinity \[AUC(0-∞)\] was calculated from the data. The values for AUC were log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence and period, and a random factor for subject.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
Predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 and 168 hours
Results posted on
2018-10-05
Participant Flow
Participant milestones
| Measure |
LY2608204 Test, LY2608204 Reference
A single oral dose of 80 mg LY2608204 test formulation in Period 1 and a single oral dose of 80 mg LY2608204 reference formulation in Period 2. There is a washout period of at least 14 days between dosing periods.
|
LY2608204 Reference, LY2608204 Test
A single oral dose of 80 mg LY2608204 reference formulation in Period 1 and a single oral dose of 80 mg LY2608204 test formulation in Period 2. There is a washout period of at least 14 days between dosing periods.
|
|---|---|---|
|
Period 1
STARTED
|
8
|
8
|
|
Period 1
COMPLETED
|
8
|
6
|
|
Period 1
NOT COMPLETED
|
0
|
2
|
|
Period 2
STARTED
|
8
|
6
|
|
Period 2
COMPLETED
|
8
|
6
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
LY2608204 Test, LY2608204 Reference
A single oral dose of 80 mg LY2608204 test formulation in Period 1 and a single oral dose of 80 mg LY2608204 reference formulation in Period 2. There is a washout period of at least 14 days between dosing periods.
|
LY2608204 Reference, LY2608204 Test
A single oral dose of 80 mg LY2608204 reference formulation in Period 1 and a single oral dose of 80 mg LY2608204 test formulation in Period 2. There is a washout period of at least 14 days between dosing periods.
|
|---|---|---|
|
Period 1
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
A Study to Compare Two Forms of LY2608204 in Healthy People
Baseline characteristics by cohort
| Measure |
All Participants
n=16 Participants
A single oral dose of 80 mg LY2608204 reference formulation in Period 1 and a single oral dose of 80 mg LY2608204 test formulation in Period 2; or a single oral dose of 80 mg test formulation in Period 1 and a single oral dose of 80 mg reference formulation in Period 2. There is a washout period of at least 14 days between dosing periods.
|
|---|---|
|
Age, Continuous
|
34.3 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Singapore
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 and 168 hoursPopulation: All randomized participants who took at least one dose of study drug.
Area under the concentration versus time curve from zero to infinity \[AUC(0-∞)\] was calculated from the data. The values for AUC were log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence and period, and a random factor for subject.
Outcome measures
| Measure |
LY2608204 Free Base (Reference Formulation)
n=16 Participants
a single oral dose of 80 mg LY2608204 reference formulation (free base)
|
LY2608204 Hydrochloride (HCl) Salt (Test Formulation)
n=14 Participants
a single oral dose of 80 mg LY2608204 test formulation (HCl salt)
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞])
|
974 nanogram.hour per milliliter (ng.h/mL)
Geometric Coefficient of Variation 39
|
1080 nanogram.hour per milliliter (ng.h/mL)
Geometric Coefficient of Variation 35
|
PRIMARY outcome
Timeframe: Predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 and 168 hoursPopulation: All randomized participants who took at least one dose of study drug.
Maximum observed drug concentration (Cmax) was observed from the data. The values for Cmax were log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence and period, and a random factor for subject.
Outcome measures
| Measure |
LY2608204 Free Base (Reference Formulation)
n=16 Participants
a single oral dose of 80 mg LY2608204 reference formulation (free base)
|
LY2608204 Hydrochloride (HCl) Salt (Test Formulation)
n=14 Participants
a single oral dose of 80 mg LY2608204 test formulation (HCl salt)
|
|---|---|---|
|
Maximum Observed Drug Concentration (Cmax)
|
24.9 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 27
|
30.3 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 33
|
Adverse Events
LY2608204 Reference Formulation
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
LY2608204 Test Formulation
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LY2608204 Reference Formulation
n=16 participants at risk
A single oral dose of 80 mg LY2608204 reference formulation.
|
LY2608204 Test Formulation
n=14 participants at risk
A single oral dose of 80 mg LY2608204 test formulation.
|
|---|---|---|
|
General disorders
Fatigue
|
0.00%
0/16
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Hunger
|
25.0%
4/16 • Number of events 5
|
21.4%
3/14 • Number of events 3
|
|
General disorders
Infusion site pain
|
0.00%
0/16
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Vessel puncture site haematoma
|
25.0%
4/16 • Number of events 5
|
35.7%
5/14 • Number of events 7
|
|
General disorders
Vessel puncture site reaction
|
43.8%
7/16 • Number of events 7
|
14.3%
2/14 • Number of events 2
|
|
General disorders
Vessel puncture site swelling
|
6.2%
1/16 • Number of events 1
|
7.1%
1/14 • Number of events 1
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/16
|
7.1%
1/14 • Number of events 1
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/16
|
7.1%
1/14 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/16
|
14.3%
2/14 • Number of events 2
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/16
|
7.1%
1/14 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/16
|
7.1%
1/14 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16
|
7.1%
1/14 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/16
|
7.1%
1/14 • 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