Trial Outcomes & Findings for A Study of [¹⁴C]-LY3202626 in Healthy Male Participants (NCT NCT02555449)
NCT ID: NCT02555449
Last Updated: 2021-04-19
Results Overview
Fecal excretion of radioactivity over time expressed as a percentage of the total radioactive dose administered.
COMPLETED
PHASE1
6 participants
Predose, 6, 12, 24, 48, 72 Hours At 24 Hour Intervals Until Release Criteria Met
2021-04-19
Participant Flow
Participant milestones
| Measure |
[¹⁴C]-LY3202626
Single 10 milligram (mg) oral dose of LY3202626 containing 100 micro curies of radioactivity
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of [¹⁴C]-LY3202626 in Healthy Male Participants
Baseline characteristics by cohort
| Measure |
[¹⁴C]-LY3202626
n=6 Participants
Single oral dose of LY3202626 containing (10 milligrams) 100 micro curies of radioactivity
|
|---|---|
|
Age, Continuous
|
45.7 years
STANDARD_DEVIATION 11.3 • n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=99 Participants
|
|
Weight
|
86.40 Kilogram (kg)
STANDARD_DEVIATION 6.30 • n=99 Participants
|
|
Body Mass Index (BMI)
|
27.90 Kilogram/Square Meter (kg/m²)
STANDARD_DEVIATION 0.30 • n=99 Participants
|
PRIMARY outcome
Timeframe: Predose, 6, 12, 24, 48, 72 Hours At 24 Hour Intervals Until Release Criteria MetPopulation: All participants who received the study drug and have evaluable pharmacokinetics (PK) data.
Fecal excretion of radioactivity over time expressed as a percentage of the total radioactive dose administered.
Outcome measures
| Measure |
[¹⁴C]-LY3202626
n=6 Participants
Single 10-mg oral dose of LY3202626 containing approximately 100 microcuries of \[14C\]-LY3202626.
|
|---|---|
|
Fecal Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
|
31.3 percentage of the total radioactive dose
Standard Deviation 4.24
|
PRIMARY outcome
Timeframe: Predose, 6, 12, 24, 48, 72 Hours At 24 Hour Intervals Until Release Criteria MetPopulation: All participants who received the study drug and have evaluable PK data.
Urinary excretion of radioactivity over time was expressed as a percentage of the total radioactive dose administered
Outcome measures
| Measure |
[¹⁴C]-LY3202626
n=6 Participants
Single 10-mg oral dose of LY3202626 containing approximately 100 microcuries of \[14C\]-LY3202626.
|
|---|---|
|
Urinary Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
|
44.2 percentage of the total radioactive dose
Standard Deviation 3.70
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours At 24 Hour Intervals Until Release Criteria MetPopulation: All participants who received the study drug and have evaluable PK data.
Plasma radioactivity pharmacokinetics were measured by the maximum observed concentration (Cmax).
Outcome measures
| Measure |
[¹⁴C]-LY3202626
n=6 Participants
Single 10-mg oral dose of LY3202626 containing approximately 100 microcuries of \[14C\]-LY3202626.
|
|---|---|
|
Plasma Radioactivity Pharmacokinetics Maximum Observed Concentration (Cmax)
|
25.2 nanogram/millilter (ng/mL)
Geometric Coefficient of Variation 16
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours At 24 Hour Intervals Until Release Criteria MetPopulation: All participants who received the study drug and have evaluable PK data.
Plasma radioactivity pharmacokinetics were measured by the area under the concentration-time curve from time zero to infinity (AUC\[0-∞\]).
Outcome measures
| Measure |
[¹⁴C]-LY3202626
n=6 Participants
Single 10-mg oral dose of LY3202626 containing approximately 100 microcuries of \[14C\]-LY3202626.
|
|---|---|
|
Plasma Radioactivity Pharmacokinetics Area Under the Concentration-time Curve From Time Zero to Infinity (AUC[0-∞])
|
1120 nanogram*hour/millilter (ng*h/mL)
Geometric Coefficient of Variation 27
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours At 24 Hour Intervals Until Release Criteria MetPopulation: All participants who received the study drug and have evaluable PK data.
Plasma radioactivity pharmacokinetics were measured by the area under the concentration-time curve from time zero to the last timepoint with a measurable concentration (AUC\[0-tlast\]).
Outcome measures
| Measure |
[¹⁴C]-LY3202626
n=6 Participants
Single 10-mg oral dose of LY3202626 containing approximately 100 microcuries of \[14C\]-LY3202626.
|
|---|---|
|
Plasma Radioactivity Pharmacokinetics Area Under the Concentration-time Curve From Time Zero to the Last Timepoint With a Measurable Concentration (AUC[0-tlast])
|
814 ng*h/mL
Standard Deviation 31
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 Hours PostdosePopulation: All participants who received the study drug and have evaluable PK data.
Total number of metabolites were identified in at least 10% of the total radioactivity in plasma.
Outcome measures
| Measure |
[¹⁴C]-LY3202626
n=6 Participants
Single 10-mg oral dose of LY3202626 containing approximately 100 microcuries of \[14C\]-LY3202626.
|
|---|---|
|
Total Number of Metabolites Representing at Least 10% of the Total Radioactivity in Plasma
|
1 metabolites
|
SECONDARY outcome
Timeframe: From Dosing Until Release Criteria Is MetPopulation: All participants who received the study drug and had evaluable PK data.
The total number of metabolites identified in excreta (urine and feces) that represent at least 10% of the dose of radioactivity
Outcome measures
| Measure |
[¹⁴C]-LY3202626
n=6 Participants
Single 10-mg oral dose of LY3202626 containing approximately 100 microcuries of \[14C\]-LY3202626.
|
|---|---|
|
Total Number of Metabolites in Excreta (Urine and Feces) That Represent at Least 10% of the Dose of Radioactivity
|
2 metabolites
|
Adverse Events
[¹⁴C]-LY3202626
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
[¹⁴C]-LY3202626
n=6 participants at risk
Single 10 mg oral dose of LY3202626 containing 100 micro curies of radioactivity
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
3/6 • Number of events 3 • From Baseline through End of Study (Up to 2 Months)
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1 • From Baseline through End of Study (Up to 2 Months)
|
|
General disorders
Tenderness
|
16.7%
1/6 • Number of events 1 • From Baseline through End of Study (Up to 2 Months)
|
|
Injury, poisoning and procedural complications
Contusion
|
16.7%
1/6 • Number of events 1 • From Baseline through End of Study (Up to 2 Months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60