Trial Outcomes & Findings for A Study of LY3337641 in Healthy Male Participants (NCT NCT02914379)

NCT ID: NCT02914379

Last Updated: 2023-08-25

Results Overview

Urinary excretion samples from each participant were measured by liquid scintillation counting. The radioactive counts detected in urine samples were each divided by the theoretical radioactive count in the total radioactive dose administered and multiplied by 100% to arrive at a percentage of total radioactive dose excreted in urine and feces.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

6 participants

Primary outcome timeframe

Baseline up to 22 days

Results posted on

2023-08-25

Participant Flow

Participant milestones

Participant milestones
Measure	20mg [¹⁴C]-LY3337641 Participants received 20 milligrams (mg) oral dose of LY3337641 containing 120 microcuries 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 LY3337641 in Healthy Male Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	20mg [¹⁴C]-LY3337641 n=6 Participants Participants received 20 mg oral dose of LY3337641 containing 120 microcuries of radioactivity.
Age, Continuous	34.3 Years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to 22 days

Population: All participants who received the study drug and have evaluable pharmacokinetic (PK) data.

Urinary excretion samples from each participant were measured by liquid scintillation counting. The radioactive counts detected in urine samples were each divided by the theoretical radioactive count in the total radioactive dose administered and multiplied by 100% to arrive at a percentage of total radioactive dose excreted in urine and feces.

Outcome measures

Outcome measures
Measure	20 mg [¹⁴C]-LY3337641 n=6 Participants Participants received 20 mg oral dose of LY3337641 containing 120 microcuries of radioactivity.
Urinary Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered	2.9 Percentage of total dose Standard Deviation 1.0

PRIMARY outcome

Timeframe: Baseline up to 22 days

Population: All participants who received the study drug and have evaluable PK data.

Fecal excretion samples from each participant were measured by liquid scintillation counting. The radioactive counts detected in fecal samples were each divided by the theoretical radioactive count in the total radioactive dose administered and multiplied by 100% to arrive at a percentage of total radioactive dose excreted in feces.

Outcome measures

Outcome measures
Measure	20 mg [¹⁴C]-LY3337641 n=6 Participants Participants received 20 mg oral dose of LY3337641 containing 120 microcuries of radioactivity.
Fecal Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered	86.4 Percentage of total dose Standard Deviation 5.1

SECONDARY outcome

Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose

Population: All participants who received the study drug and have evaluable PK data.

Outcome measures

Outcome measures
Measure	20 mg [¹⁴C]-LY3337641 n=6 Participants Participants received 20 mg oral dose of LY3337641 containing 120 microcuries of radioactivity.
Pharmacokinetics: Maximum Observed Concentration (Cmax) of Plasma LY3337641	77.9 Nanograms/milliliter (ng/mL) Geometric Coefficient of Variation 26

SECONDARY outcome

Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose

Population: All participants who received the study drug and have evaluable PK data.

Outcome measures

Outcome measures
Measure	20 mg [¹⁴C]-LY3337641 n=6 Participants Participants received 20 mg oral dose of LY3337641 containing 120 microcuries of radioactivity.
Pharmacokinetics: Maximum Observed Concentration (Cmax) of Plasma Radioactivity	122 nanogram equivalents/g (ng-equiv/g) Geometric Coefficient of Variation 25

SECONDARY outcome

Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose

Population: All participants who received the study drug and have evaluable PK data.

Outcome measures

Outcome measures
Measure	20 mg [¹⁴C]-LY3337641 n=6 Participants Participants received 20 mg oral dose of LY3337641 containing 120 microcuries of radioactivity.
Pharmacokinetics: Maximum Observed Concentration (Cmax) of Whole Blood Radioactivity	67.5 ng/mL Geometric Coefficient of Variation 24

SECONDARY outcome

Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose

Population: All participants who received the study drug and have evaluable PK data.

Outcome measures

Outcome measures
Measure	20 mg [¹⁴C]-LY3337641 n=6 Participants Participants received 20 mg oral dose of LY3337641 containing 120 microcuries of radioactivity.
Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC 0 to ∞) of Plasma LY3337641	370 Nanogramshours per milliliter (ngh/mL) Geometric Coefficient of Variation 25

SECONDARY outcome

Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose

Population: All participants who received the study drug and have evaluable PK data.

Outcome measures

Outcome measures
Measure	20 mg [¹⁴C]-LY3337641 n=6 Participants Participants received 20 mg oral dose of LY3337641 containing 120 microcuries of radioactivity.
Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC 0 to ∞) of Plasma Radioactivity	1240 ng-equivalentsh/gram (ng-equivh/g) Geometric Coefficient of Variation 51

SECONDARY outcome

Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose

Population: All participants who received the study drug and have evaluable PK data.

Outcome measures

Outcome measures
Measure	20 mg [¹⁴C]-LY3337641 n=6 Participants Participants received 20 mg oral dose of LY3337641 containing 120 microcuries of radioactivity.
Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC 0 to ∞) of Whole Blood Radioactivity	5840 ng*h/mL Geometric Coefficient of Variation 105

SECONDARY outcome

Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264, and 312 hours postdose

Population: All participants who received the study drug and have evaluable PK data.

Outcome measures

Outcome measures
Measure	20 mg [¹⁴C]-LY3337641 n=6 Participants Participants received 20 mg oral dose of LY3337641 containing 120 microcuries of radioactivity.
Pharmacokinetics: Total Number of Measurable Metabolites of LY3337641 in Plasma, Urine and Feces Plasma	6 Number of Metabolites
Pharmacokinetics: Total Number of Measurable Metabolites of LY3337641 in Plasma, Urine and Feces Urine	4 Number of Metabolites
Pharmacokinetics: Total Number of Measurable Metabolites of LY3337641 in Plasma, Urine and Feces Feces	8 Number of Metabolites

Adverse Events

20 mg [¹⁴C]-LY3337641

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	20 mg [¹⁴C]-LY3337641 n=6 participants at risk Participants received 20 mg oral dose of LY3337641 containing 120 microcuries of radioactivity.
Gastrointestinal disorders Abdominal discomfort	16.7% 1/6 • Number of events 1 • From Baseline to End of Study (Up to 29 Days)
Gastrointestinal disorders Change of bowel habit	16.7% 1/6 • Number of events 1 • From Baseline to End of Study (Up to 29 Days)
Gastrointestinal disorders Diarrhoea	16.7% 1/6 • Number of events 1 • From Baseline to End of Study (Up to 29 Days)
Skin and subcutaneous tissue disorders Ecchymosis	16.7% 1/6 • Number of events 1 • From Baseline to End of Study (Up to 29 Days)

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60