Trial Outcomes & Findings for A Study of LY2881835 in Healthy People and People With Diabetes (NCT NCT01358981)
NCT ID: NCT01358981
Last Updated: 2019-06-19
Results Overview
Clinically significant adverse effects are treatment emergent adverse events (TEAEs) possibly related to study drug.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
Baseline to study completion up to 3 months
Results posted on
2019-06-19
Participant Flow
This is a 2-part (Part A and Part B) crossover study with four periods.In Part A, 8 participants were dosed at each dose level in 4 study periods (1 additional participant was dosed only in 1 study period). In Part B, a single cohort of 9 participants with type 2 diabetes mellitus (T2DM) participated in 3 dosing periods.
Participant milestones
| Measure |
Cohort 1: Part A (Healthy): Sequence 1
Participants received single oral doses of 0.5 milligram (mg), 1.5 mg, 4.5 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence.
Period 1: 0.5 mg LY2881835, Period 2: 1.5 mg LY2881835, Period 3: 4.5 mg LY2881835, Period 4: Placebo.
|
Cohort 1: Part A (Healthy): Sequence 2
Participants received single oral doses of 0.5 mg, 1.5 mg, 8.4 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence.
Period 1: 0.5 mg LY2881835, Period 2: 1.5 mg LY2881835, Period 3: Placebo, Period 4: 8.4 mg LY2881835.
|
Cohort 1: Part A (Healthy): Sequence 3
Participants received single oral doses of 0.5 mg, 4.5 mg, 8.4 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence.
Period 1: 0.5 mg LY2881835, Period 2: Placebo, Period 3: 4.5 mg LY2881835, Period 4: 8.4 mg LY2881835.
|
Cohort 1: Part A (Healthy): Sequence 4
Participants received single oral doses of 1.5 mg, 4.5 mg, 8.4 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence.
Period 1: Placebo, Period 2: 1.5 mg LY2881835, Period 3: 4.5 mg LY2881835, Period 4: 8.4 mg LY2881835.
|
Cohort 2: Part B (T2DM): Sequence 1
Participants received single oral doses of 8.4 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence.
Period 1: 8.4 mg LY2881835, Period 2: 8.4 mg LY2881835, Period 3: Placebo.
|
Cohort 2: Part B (T2DM): Sequence 2
Participants received single oral doses of 8.4 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence.
Period 1: 8.4 mg LY2881835, Period 2: Placebo, Period 3: 8.4 mg LY2881835.
|
Cohort 2: Part B (T2DM): Sequence 3
Participants received single oral doses of 8.4 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence.
Period 1: Placebo, Period 2: 8.4 mg LY2881835, Period 3: 8.4 mg LY2881835.
|
|---|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
2
|
2
|
2
|
2
|
3
|
3
|
3
|
|
Period 1
Received at Least 1dose of Study Drug
|
2
|
2
|
2
|
2
|
3
|
3
|
3
|
|
Period 1
COMPLETED
|
2
|
2
|
2
|
1
|
3
|
3
|
3
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Period 2
STARTED
|
2
|
2
|
2
|
2
|
3
|
3
|
3
|
|
Period 2
COMPLETED
|
2
|
2
|
2
|
2
|
3
|
3
|
3
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
2
|
2
|
2
|
2
|
3
|
3
|
3
|
|
Period 3
COMPLETED
|
2
|
2
|
2
|
2
|
3
|
3
|
3
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 4
STARTED
|
2
|
2
|
2
|
2
|
0
|
0
|
0
|
|
Period 4
COMPLETED
|
2
|
2
|
2
|
2
|
0
|
0
|
0
|
|
Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1: Part A (Healthy): Sequence 1
Participants received single oral doses of 0.5 milligram (mg), 1.5 mg, 4.5 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence.
Period 1: 0.5 mg LY2881835, Period 2: 1.5 mg LY2881835, Period 3: 4.5 mg LY2881835, Period 4: Placebo.
|
Cohort 1: Part A (Healthy): Sequence 2
Participants received single oral doses of 0.5 mg, 1.5 mg, 8.4 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence.
Period 1: 0.5 mg LY2881835, Period 2: 1.5 mg LY2881835, Period 3: Placebo, Period 4: 8.4 mg LY2881835.
|
Cohort 1: Part A (Healthy): Sequence 3
Participants received single oral doses of 0.5 mg, 4.5 mg, 8.4 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence.
Period 1: 0.5 mg LY2881835, Period 2: Placebo, Period 3: 4.5 mg LY2881835, Period 4: 8.4 mg LY2881835.
|
Cohort 1: Part A (Healthy): Sequence 4
Participants received single oral doses of 1.5 mg, 4.5 mg, 8.4 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence.
Period 1: Placebo, Period 2: 1.5 mg LY2881835, Period 3: 4.5 mg LY2881835, Period 4: 8.4 mg LY2881835.
|
Cohort 2: Part B (T2DM): Sequence 1
Participants received single oral doses of 8.4 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence.
Period 1: 8.4 mg LY2881835, Period 2: 8.4 mg LY2881835, Period 3: Placebo.
|
Cohort 2: Part B (T2DM): Sequence 2
Participants received single oral doses of 8.4 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence.
Period 1: 8.4 mg LY2881835, Period 2: Placebo, Period 3: 8.4 mg LY2881835.
|
Cohort 2: Part B (T2DM): Sequence 3
Participants received single oral doses of 8.4 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence.
Period 1: Placebo, Period 2: 8.4 mg LY2881835, Period 3: 8.4 mg LY2881835.
|
|---|---|---|---|---|---|---|---|
|
Period 1
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study of LY2881835 in Healthy People and People With Diabetes
Baseline characteristics by cohort
| Measure |
Cohort 1: Part A (Healthy): Sequence 1
n=2 Participants
Participants received single oral doses of 0.5 milligram (mg), 1.5 mg, 4.5 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence.
Period 1: 0.5 mg LY2881835, Period 2: 1.5 mg LY2881835, Period 3: 4.5 mg LY2881835, Period 4: Placebo.
|
Cohort 1: Part A (Healthy): Sequence 2
n=2 Participants
Participants received single oral doses of 0.5 mg, 1.5 mg, 8.4 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence.
Period 1: 0.5 mg LY2881835, Period 2: 1.5 mg LY2881835, Period 3: Placebo, Period 4: 8.4 mg LY2881835.
|
Cohort 1: Part A (Healthy): Sequence 3
n=2 Participants
Participants received single oral doses of 0.5 mg, 4.5 mg, 8.4 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence.
Period 1: 0.5 mg LY2881835, Period 2: Placebo, Period 3: 4.5 mg LY2881835, Period 4: 8.4 mg LY2881835.
|
Cohort 1: Part A (Healthy): Sequence 4
n=3 Participants
Participants received single oral doses of 1.5 mg, 4.5 mg, 8.4 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence.
Period 1: Placebo, Period 2: 1.5 mg LY2881835, Period 3: 4.5 mg LY2881835, Period 4: 8.4 mg LY2881835.
|
Cohort 2: Part B (T2DM): Sequence 1
n=3 Participants
Participants received single oral doses of 8.4 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence.
Period 1: 8.4 mg LY2881835, Period 2: 8.4 mg LY2881835, Period 3: Placebo.
|
Cohort 2: Part B (T2DM): Sequence 2
n=3 Participants
Participants received single oral doses of 8.4 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence.
Period 1: 8.4 mg LY2881835, Period 2: Placebo, Period 3: 8.4 mg LY2881835.
|
Cohort 2: Part B (T2DM): Sequence 3
n=3 Participants
Participants received single oral doses of 8.4 mg LY2881835 and placebo capsules on day 1 of each treatment period as per the below dosing sequence.
Period 1: Placebo, Period 2: 8.4 mg LY2881835, Period 3: 8.4 mg LY2881835.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
18 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
10 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
18 Participants
n=24 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
18 Participants
n=24 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Region of Enrollment
Singapore
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
18 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline to study completion up to 3 monthsPopulation: All enrolled participants who received study drug.
Clinically significant adverse effects are treatment emergent adverse events (TEAEs) possibly related to study drug.
Outcome measures
| Measure |
Part A - Placebo
n=9 Participants
Single oral dose of placebo in a study period in Part A (Healthy).
|
Part A - 0.5 mg LY2881835
n=6 Participants
Single oral dose of 0.5 milligram (mg) LY2881835 in a study period in Part A (Healthy).
|
Part A - 1.5 mg LY2881835
n=6 Participants
Single oral dose of 1.5 mg LY2881835 in a study period in Part A (Healthy).
|
Part A - 4.5 mg LY2881835
n=6 Participants
Single oral dose of 4.5 mg LY2881835 in a study period in Part A (Healthy).
|
Part A - 8.4 mg LY2881835
n=6 Participants
Single oral dose of 8.4 mg LY2881835 in a study period in Part A (Healthy).
|
Part B - Placebo
n=9 Participants
Single oral dose of placebo in a study period in Part B \[Type 2 Diabetes Mellitus (T2DM)\].
|
Part B - 8.4 mg LY2881835
n=9 Participants
Single oral dose of 8.4 mg LY2881835 in 2 of the 3 study periods in Part B (T2DM).
|
Part B, Study Periods 1, 2, and 3 - 8.4 mg LY2881835
Single oral dose of 8.4 mg LY2881835 in 2 of the 3 study periods in Part B (T2DM).
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Adverse Effects
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
—
|
SECONDARY outcome
Timeframe: Part A: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24hours (h) post-dose; Part B: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dosePopulation: All participants who received study drug and had evaluable PK data. Each participant in group Part B, Study Periods 1, 2 and 3 - 8.4 mg LY2881835 was dosed and had corresponding PK measures in 2 of the 3 study periods in Part B resulting in 18 samples being analyzed. Analysis used data according to the treatment the participants actually received.
Not all the participants had quantifiable plasma concentrations at 48 hours, therefore only AUC from time zero to 24 hours \[AUC(0-24 hours)\] is provided.
Outcome measures
| Measure |
Part A - Placebo
n=6 Samples
Single oral dose of placebo in a study period in Part A (Healthy).
|
Part A - 0.5 mg LY2881835
n=6 Samples
Single oral dose of 0.5 milligram (mg) LY2881835 in a study period in Part A (Healthy).
|
Part A - 1.5 mg LY2881835
n=6 Samples
Single oral dose of 1.5 mg LY2881835 in a study period in Part A (Healthy).
|
Part A - 4.5 mg LY2881835
n=6 Samples
Single oral dose of 4.5 mg LY2881835 in a study period in Part A (Healthy).
|
Part A - 8.4 mg LY2881835
n=6 Samples
Single oral dose of 8.4 mg LY2881835 in a study period in Part A (Healthy).
|
Part B - Placebo
n=6 Samples
Single oral dose of placebo in a study period in Part B \[Type 2 Diabetes Mellitus (T2DM)\].
|
Part B - 8.4 mg LY2881835
n=6 Samples
Single oral dose of 8.4 mg LY2881835 in 2 of the 3 study periods in Part B (T2DM).
|
Part B, Study Periods 1, 2, and 3 - 8.4 mg LY2881835
n=18 Samples
Single oral dose of 8.4 mg LY2881835 in 2 of the 3 study periods in Part B (T2DM).
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Curve (AUC) of LY2881835
|
54.8 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 39
|
125 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 47
|
340 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 31
|
767 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 48
|
820 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 20
|
683 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 26
|
658 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 43
|
717 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 31
|
SECONDARY outcome
Timeframe: Part A: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose; Part B: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dosePopulation: All participants who received study drug and had evaluable PK data. Each participant in group Part B, Study Periods 1, 2 and 3 - 8.4 mg LY2881835 was dosed and had corresponding PK measures in 2 of the 3 study periods in Part B resulting in 18 samples being analyzed. Analysis used data according to the treatment the participants actually received.
Not all the participants had quantifiable plasma concentrations at 48 hours, therefore only Cmax up to 24 hours post-dose is provided.
Outcome measures
| Measure |
Part A - Placebo
n=6 Samples
Single oral dose of placebo in a study period in Part A (Healthy).
|
Part A - 0.5 mg LY2881835
n=6 Samples
Single oral dose of 0.5 milligram (mg) LY2881835 in a study period in Part A (Healthy).
|
Part A - 1.5 mg LY2881835
n=6 Samples
Single oral dose of 1.5 mg LY2881835 in a study period in Part A (Healthy).
|
Part A - 4.5 mg LY2881835
n=6 Samples
Single oral dose of 4.5 mg LY2881835 in a study period in Part A (Healthy).
|
Part A - 8.4 mg LY2881835
n=6 Samples
Single oral dose of 8.4 mg LY2881835 in a study period in Part A (Healthy).
|
Part B - Placebo
n=6 Samples
Single oral dose of placebo in a study period in Part B \[Type 2 Diabetes Mellitus (T2DM)\].
|
Part B - 8.4 mg LY2881835
n=6 Samples
Single oral dose of 8.4 mg LY2881835 in 2 of the 3 study periods in Part B (T2DM).
|
Part B, Study Periods 1, 2, and 3 - 8.4 mg LY2881835
n=18 Samples
Single oral dose of 8.4 mg LY2881835 in 2 of the 3 study periods in Part B (T2DM).
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) Of LY2881835
|
7.44 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 16
|
14.7 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 38
|
47.1 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 25
|
89.9 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 42
|
93.0 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 30
|
85.1 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 32
|
77.8 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 21
|
85.1 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 27
|
SECONDARY outcome
Timeframe: Part A: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose; Part B: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dosePopulation: All participants who received study drug and had evaluable PK data. Each participant in group Part B, Study Periods 1, 2 and 3 - 8.4 mg LY2881835 was dosed and had corresponding PK measures in 2 of the 3 study periods in Part B resulting in 18 samples being analyzed. Analysis used data according to the treatment the participants actually received.
Not all the participants had quantifiable plasma concentrations at 48 hours, therefore only Tmax up to 24 hours post dose is provided.
Outcome measures
| Measure |
Part A - Placebo
n=6 Samples
Single oral dose of placebo in a study period in Part A (Healthy).
|
Part A - 0.5 mg LY2881835
n=6 Samples
Single oral dose of 0.5 milligram (mg) LY2881835 in a study period in Part A (Healthy).
|
Part A - 1.5 mg LY2881835
n=6 Samples
Single oral dose of 1.5 mg LY2881835 in a study period in Part A (Healthy).
|
Part A - 4.5 mg LY2881835
n=6 Samples
Single oral dose of 4.5 mg LY2881835 in a study period in Part A (Healthy).
|
Part A - 8.4 mg LY2881835
n=6 Samples
Single oral dose of 8.4 mg LY2881835 in a study period in Part A (Healthy).
|
Part B - Placebo
n=6 Samples
Single oral dose of placebo in a study period in Part B \[Type 2 Diabetes Mellitus (T2DM)\].
|
Part B - 8.4 mg LY2881835
n=6 Samples
Single oral dose of 8.4 mg LY2881835 in 2 of the 3 study periods in Part B (T2DM).
|
Part B, Study Periods 1, 2, and 3 - 8.4 mg LY2881835
n=18 Samples
Single oral dose of 8.4 mg LY2881835 in 2 of the 3 study periods in Part B (T2DM).
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of LY2881835
|
2.50 hours
Interval 1.5 to 4.0
|
2.50 hours
Interval 1.5 to 4.0
|
3.25 hours
Interval 2.5 to 6.0
|
2.50 hours
Interval 1.5 to 4.02
|
4.25 hours
Interval 1.5 to 6.0
|
3.25 hours
Interval 2.5 to 6.0
|
4.25 hours
Interval 1.5 to 6.0
|
3.25 hours
Interval 1.5 to 6.0
|
SECONDARY outcome
Timeframe: Part A: Predose, 1.0, 1.5, 2.5, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 18 and 24 h post-dose; Part B: Predose, 1.0, 1.5, 2.5, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 18 and 24 h post-dosePopulation: All participants who received study drug and had evaluable glucose data. Each participant in group Part B, Study Periods (SP) 1, 2 and 3-8.4 mg LY2881835 was dosed and had corresponding glucose measures in 2 of the 3 SP in Part B resulting in 18 samples being analyzed. Analysis used data according to the treatment participants actually received.
Glucose area under the serum concentration versus time curve (AUEC) was calculated using the linear trapezoidal rule from time 0 to 24 hours.
Outcome measures
| Measure |
Part A - Placebo
n=9 Samples
Single oral dose of placebo in a study period in Part A (Healthy).
|
Part A - 0.5 mg LY2881835
n=6 Samples
Single oral dose of 0.5 milligram (mg) LY2881835 in a study period in Part A (Healthy).
|
Part A - 1.5 mg LY2881835
n=6 Samples
Single oral dose of 1.5 mg LY2881835 in a study period in Part A (Healthy).
|
Part A - 4.5 mg LY2881835
n=6 Samples
Single oral dose of 4.5 mg LY2881835 in a study period in Part A (Healthy).
|
Part A - 8.4 mg LY2881835
n=6 Samples
Single oral dose of 8.4 mg LY2881835 in a study period in Part A (Healthy).
|
Part B - Placebo
n=9 Samples
Single oral dose of placebo in a study period in Part B \[Type 2 Diabetes Mellitus (T2DM)\].
|
Part B - 8.4 mg LY2881835
n=18 Samples
Single oral dose of 8.4 mg LY2881835 in 2 of the 3 study periods in Part B (T2DM).
|
Part B, Study Periods 1, 2, and 3 - 8.4 mg LY2881835
Single oral dose of 8.4 mg LY2881835 in 2 of the 3 study periods in Part B (T2DM).
|
|---|---|---|---|---|---|---|---|---|
|
Glucose Area Under the Effective Concentration Curve (AUEC)
|
2282 milligrams*hour/deciliter (mg*hr/dL)
Standard Deviation 291
|
2448 milligrams*hour/deciliter (mg*hr/dL)
Standard Deviation 183
|
2089 milligrams*hour/deciliter (mg*hr/dL)
Standard Deviation 146
|
2354 milligrams*hour/deciliter (mg*hr/dL)
Standard Deviation 72
|
2159 milligrams*hour/deciliter (mg*hr/dL)
Standard Deviation 133
|
3640 milligrams*hour/deciliter (mg*hr/dL)
Standard Deviation 711
|
3769 milligrams*hour/deciliter (mg*hr/dL)
Standard Deviation 719
|
—
|
SECONDARY outcome
Timeframe: Part A: Predose, 1.5 and 2.5 h post-dose; Part B: Predose, 1.5 and 2.5 h post-dosePopulation: All participants who received study drug and had evaluable GLP-1 data. Each participant in group Part B, Study Periods (SP) 1, 2 and 3-8.4 mg LY2881835 was dosed and had corresponding GLP-1 measures in 2 of the 3 SP in Part B resulting in 18 samples being analyzed. Analysis used data according to the treatment participants actually received.
Glucagon-like peptide (active GLP-1) area under the serum concentration versus time curve (AUEC) was calculated using the linear trapezoidal rule from time 0 to 2.5 hours.
Outcome measures
| Measure |
Part A - Placebo
n=9 Samples
Single oral dose of placebo in a study period in Part A (Healthy).
|
Part A - 0.5 mg LY2881835
n=6 Samples
Single oral dose of 0.5 milligram (mg) LY2881835 in a study period in Part A (Healthy).
|
Part A - 1.5 mg LY2881835
n=6 Samples
Single oral dose of 1.5 mg LY2881835 in a study period in Part A (Healthy).
|
Part A - 4.5 mg LY2881835
n=6 Samples
Single oral dose of 4.5 mg LY2881835 in a study period in Part A (Healthy).
|
Part A - 8.4 mg LY2881835
n=6 Samples
Single oral dose of 8.4 mg LY2881835 in a study period in Part A (Healthy).
|
Part B - Placebo
n=9 Samples
Single oral dose of placebo in a study period in Part B \[Type 2 Diabetes Mellitus (T2DM)\].
|
Part B - 8.4 mg LY2881835
n=18 Samples
Single oral dose of 8.4 mg LY2881835 in 2 of the 3 study periods in Part B (T2DM).
|
Part B, Study Periods 1, 2, and 3 - 8.4 mg LY2881835
Single oral dose of 8.4 mg LY2881835 in 2 of the 3 study periods in Part B (T2DM).
|
|---|---|---|---|---|---|---|---|---|
|
Glucagon-Like Peptide (Active GLP-1) Area Under the Effective Concentration Curve (AUEC)
|
3.029 picomoles*hour/liter (pmol*h/L)
Standard Deviation 1.097
|
3.277 picomoles*hour/liter (pmol*h/L)
Standard Deviation 1.032
|
2.838 picomoles*hour/liter (pmol*h/L)
Standard Deviation 0.759
|
3.113 picomoles*hour/liter (pmol*h/L)
Standard Deviation 1.389
|
3.362 picomoles*hour/liter (pmol*h/L)
Standard Deviation 0.938
|
4.249 picomoles*hour/liter (pmol*h/L)
Standard Deviation 2.140
|
5.268 picomoles*hour/liter (pmol*h/L)
Standard Deviation 2.266
|
—
|
SECONDARY outcome
Timeframe: Part A: Predose, 1.0, 1.5, 2.5, 4, 5, 6 and 24 h post-dose; Part B: Predose, 1.0, 1.5, 2.5, 4, 5, 6 and 24 h post-dosePopulation: All participants who received study drug and had evaluable C-Peptide data. Each participant in group Part B, Study Periods (SP) 1, 2, 3-8.4 mg LY2881835 was dosed and had corresponding C-Peptide measures in 2 of the 3 SP in Part B resulting in 18 samples being analyzed. Analysis used data according to the treatment participants actually received.
C-Peptide area under the serum concentration versus time curve (AUEC) was calculated using the linear trapezoidal rule from time 0 to 6 hours.
Outcome measures
| Measure |
Part A - Placebo
n=9 Samples
Single oral dose of placebo in a study period in Part A (Healthy).
|
Part A - 0.5 mg LY2881835
n=6 Samples
Single oral dose of 0.5 milligram (mg) LY2881835 in a study period in Part A (Healthy).
|
Part A - 1.5 mg LY2881835
n=6 Samples
Single oral dose of 1.5 mg LY2881835 in a study period in Part A (Healthy).
|
Part A - 4.5 mg LY2881835
n=6 Samples
Single oral dose of 4.5 mg LY2881835 in a study period in Part A (Healthy).
|
Part A - 8.4 mg LY2881835
n=6 Samples
Single oral dose of 8.4 mg LY2881835 in a study period in Part A (Healthy).
|
Part B - Placebo
n=9 Samples
Single oral dose of placebo in a study period in Part B \[Type 2 Diabetes Mellitus (T2DM)\].
|
Part B - 8.4 mg LY2881835
n=18 Samples
Single oral dose of 8.4 mg LY2881835 in 2 of the 3 study periods in Part B (T2DM).
|
Part B, Study Periods 1, 2, and 3 - 8.4 mg LY2881835
Single oral dose of 8.4 mg LY2881835 in 2 of the 3 study periods in Part B (T2DM).
|
|---|---|---|---|---|---|---|---|---|
|
C-Peptide Area Under the Effective Concentration Curve (AUEC)
|
5852.8 picomoles*hour/liter (pmol*h/L)
Standard Deviation 1266.7
|
6313.7 picomoles*hour/liter (pmol*h/L)
Standard Deviation 1870.3
|
7069.5 picomoles*hour/liter (pmol*h/L)
Standard Deviation 2065.3
|
4962.2 picomoles*hour/liter (pmol*h/L)
Standard Deviation 1192.2
|
7421.5 picomoles*hour/liter (pmol*h/L)
Standard Deviation 3047.4
|
6145.6 picomoles*hour/liter (pmol*h/L)
Standard Deviation 2192.4
|
6477.8 picomoles*hour/liter (pmol*h/L)
Standard Deviation 2113.4
|
—
|
Adverse Events
Part A - Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A - 0.5 mg LY2881835
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A - 1.5 mg LY2881835
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A - 4.5 mg LY2881835
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A - 8.4 mg LY2881835
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part B - Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part B - 8.4 mg LY2881835
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part A - Placebo
n=9 participants at risk
Single oral dose of placebo in a study period in Part A (Healthy).
|
Part A - 0.5 mg LY2881835
n=6 participants at risk
Single oral dose of 0.5 milligram (mg) LY2881835 in a study period in Part A (Healthy).
|
Part A - 1.5 mg LY2881835
n=6 participants at risk
Single oral dose of 1.5 mg LY2881835 in a study period in Part A (Healthy).
|
Part A - 4.5 mg LY2881835
n=6 participants at risk
Single oral dose of 4.5 mg LY2881835 in a study period in Part A (Healthy).
|
Part A - 8.4 mg LY2881835
n=6 participants at risk
Single oral dose of 8.4 mg LY2881835 in a study period in Part A (Healthy).
|
Part B - Placebo
n=9 participants at risk
Single oral dose of placebo in a study period in Part B \[Type 2 Diabetes Mellitus (T2DM)\].
|
Part B - 8.4 mg LY2881835
n=9 participants at risk
Single oral dose of 8.4 mg LY2881835 in 2 of the 3 study periods in Part B (T2DM).
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
11.1%
1/9 • Number of events 1 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/9 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/9 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
11.1%
1/9 • Number of events 1 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
11.1%
1/9 • Number of events 2 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/9 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/9 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/9 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/9 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
11.1%
1/9 • Number of events 1 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
|
General disorders
Catheter site erythema
|
0.00%
0/9 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/9 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
11.1%
1/9 • Number of events 1 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
|
General disorders
Catheter site pain
|
0.00%
0/9 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/9 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/9 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
|
General disorders
Hunger
|
0.00%
0/9 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
33.3%
2/6 • Number of events 2 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
33.3%
2/6 • Number of events 2 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/9 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/9 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
|
General disorders
Vessel puncture site swelling
|
11.1%
1/9 • Number of events 1 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/9 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
11.1%
1/9 • Number of events 1 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
|
Infections and infestations
Influenza
|
11.1%
1/9 • Number of events 1 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/9 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/9 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
0.00%
0/9 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
33.3%
2/6 • Number of events 2 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/9 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
11.1%
1/9 • Number of events 2 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/9 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/9 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
11.1%
1/9 • Number of events 1 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/9 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/9 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/9 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/9 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
22.2%
2/9 • Number of events 2 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
22.2%
2/9 • Number of events 4 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
1/9 • Number of events 1 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/9 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/9 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/9 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
11.1%
1/9 • Number of events 1 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/9 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
11.1%
1/9 • Number of events 1 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/9 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
11.1%
1/9 • Number of events 1 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
11.1%
1/9 • Number of events 1 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/6 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/9 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
0.00%
0/9 • Baseline to study completion up to 3 months
All enrolled participants who received study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place