Trial Outcomes & Findings for Disposition of 14C-LY3009104 Following Oral Administration in Healthy Human Subjects (NCT NCT01299285)
NCT ID: NCT01299285
Last Updated: 2017-06-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
6 participants
Primary outcome timeframe
Baseline up to 120 hours
Results posted on
2017-06-08
Participant Flow
Participant milestones
| Measure |
LY3009104 (Baricitinib)
Single 10-milligram (mg) oral dose containing 100 microcuries of 14C-labeled LY3009104
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Disposition of 14C-LY3009104 Following Oral Administration in Healthy Human Subjects
Baseline characteristics by cohort
| Measure |
LY3009104
n=6 Participants
Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
|
|---|---|
|
Age, Continuous
|
36.7 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
5 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 120 hoursPopulation: Participants who took study drug.
Outcome measures
| Measure |
LY3009104
n=6 Participants
Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
|
LY3009104 Metabolites
The percentage of total radioactivity of all LY3009104 metabolites in the plasma after receiving a single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
|
|---|---|---|
|
Percentage of the Total Radioactive Dose Administered Excreted From Urine and Feces
Urine
|
75.2 percentage of total radioactivity
Standard Deviation 6.74
|
—
|
|
Percentage of the Total Radioactive Dose Administered Excreted From Urine and Feces
Feces
|
19.9 percentage of total radioactivity
Standard Deviation 4.92
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 48 hoursPopulation: Participants who took study drug.
Outcome measures
| Measure |
LY3009104
n=6 Participants
Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
|
LY3009104 Metabolites
The percentage of total radioactivity of all LY3009104 metabolites in the plasma after receiving a single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
|
|---|---|---|
|
Plasma Pharmacokinetics: LY3009104 Area Under the Concentration-Time Curve From Time Zero to Infinity [AUC(0-∞)]
|
1570 hour*nanomoles/liter(h*nmol/L)
Geometric Coefficient of Variation 28
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 48 hoursPopulation: Participants who took study drug.
Outcome measures
| Measure |
LY3009104
n=6 Participants
Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
|
LY3009104 Metabolites
The percentage of total radioactivity of all LY3009104 metabolites in the plasma after receiving a single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
|
|---|---|---|
|
Plasma Pharmacokinetics: Radioactivity Area Under the Concentration-Time Curve From Time Zero to Infinity [AUC(0-∞)]
|
1530 hour*nanomole-equivalents/kilogram
Geometric Coefficient of Variation 31
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 48 hoursPopulation: Participants who took study drug.
Outcome measures
| Measure |
LY3009104
n=6 Participants
Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
|
LY3009104 Metabolites
The percentage of total radioactivity of all LY3009104 metabolites in the plasma after receiving a single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
|
|---|---|---|
|
Plasma Pharmacokinetics: Maximum Observed LY3009104 Concentration (Cmax)
|
227 nanomoles/liter (nmol/L)
Geometric Coefficient of Variation 36
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 48 hoursPopulation: Participants who took study drug.
Outcome measures
| Measure |
LY3009104
n=6 Participants
Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
|
LY3009104 Metabolites
The percentage of total radioactivity of all LY3009104 metabolites in the plasma after receiving a single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
|
|---|---|---|
|
Plasma Pharmacokinetics: Maximum Observed Radioactivity Concentration (Cmax)
|
231 nanomole-equivalents/milliliter
Geometric Coefficient of Variation 35
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 48 hoursPopulation: Participants who took study drug.
Outcome measures
| Measure |
LY3009104
n=6 Participants
Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
|
LY3009104 Metabolites
The percentage of total radioactivity of all LY3009104 metabolites in the plasma after receiving a single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
|
|---|---|---|
|
Plasma Pharmacokinetics: LY3009104 and Radioactivity Time to Maximum Observed Concentration (Tmax)
LY3009104
|
1.00 hour
Interval 1.0 to 2.0
|
—
|
|
Plasma Pharmacokinetics: LY3009104 and Radioactivity Time to Maximum Observed Concentration (Tmax)
Radioactivity
|
1.00 hour
Interval 1.0 to 2.0
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 48 hoursPopulation: Participants who took study drug.
Percentages of LY3009104 (parent) and LY3009104 metabolites that were excreted in the urine are reported. Only those metabolites that were detectable in the urine are included in the report.
Outcome measures
| Measure |
LY3009104
n=6 Participants
Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
|
LY3009104 Metabolites
The percentage of total radioactivity of all LY3009104 metabolites in the plasma after receiving a single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
|
|---|---|---|
|
Percentage of Dose of LY3009104 and LY3009104 Metabolites in Urine
LY3009104
|
68.5 percentage of dose
|
—
|
|
Percentage of Dose of LY3009104 and LY3009104 Metabolites in Urine
Metabolite M3
|
0.9 percentage of dose
|
—
|
|
Percentage of Dose of LY3009104 and LY3009104 Metabolites in Urine
Metabolite M10
|
1.0 percentage of dose
|
—
|
|
Percentage of Dose of LY3009104 and LY3009104 Metabolites in Urine
Metabolite M22
|
3.2 percentage of dose
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 72 hoursPopulation: Participants who took study drug.
Percentages of LY3009104 (parent) and LY3009104 metabolites that were excreted in the feces are reported. Only those metabolites that were detectable in the feces are included in the report.
Outcome measures
| Measure |
LY3009104
n=6 Participants
Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
|
LY3009104 Metabolites
The percentage of total radioactivity of all LY3009104 metabolites in the plasma after receiving a single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
|
|---|---|---|
|
Percentage of Dose of LY3009104 and LY3009104 Metabolites in Feces
LY3009104
|
14.8 percentage of dose
|
—
|
|
Percentage of Dose of LY3009104 and LY3009104 Metabolites in Feces
Metabolite M12
|
0.9 percentage of dose
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 24 hoursPopulation: Participants who took study drug.
Outcome measures
| Measure |
LY3009104
n=6 Participants
Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
|
LY3009104 Metabolites
n=6 Participants
The percentage of total radioactivity of all LY3009104 metabolites in the plasma after receiving a single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
|
|---|---|---|
|
Percentage of Total Radioactivity of LY3009104 and LY3009104 Metabolites in Plasma
1 hour
|
92.3 percentage of total radioactivity
|
0 percentage of total radioactivity
|
|
Percentage of Total Radioactivity of LY3009104 and LY3009104 Metabolites in Plasma
2 hour
|
94.5 percentage of total radioactivity
|
0 percentage of total radioactivity
|
|
Percentage of Total Radioactivity of LY3009104 and LY3009104 Metabolites in Plasma
4 hour
|
97.0 percentage of total radioactivity
|
0 percentage of total radioactivity
|
|
Percentage of Total Radioactivity of LY3009104 and LY3009104 Metabolites in Plasma
8 hour
|
91.2 percentage of total radioactivity
|
0 percentage of total radioactivity
|
|
Percentage of Total Radioactivity of LY3009104 and LY3009104 Metabolites in Plasma
24 hour
|
0 percentage of total radioactivity
|
0 percentage of total radioactivity
|
Adverse Events
LY3009104
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LY3009104
n=6 participants at risk
Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
|
|---|---|
|
Eye disorders
Ocular hyperaemia
|
16.7%
1/6 • 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
Restriction type: GT60