Trial Outcomes & Findings for A Study of How the Body Breaks Down and Eliminates LY2623091 (NCT NCT02242981)

NCT ID: NCT02242981

Last Updated: 2020-06-26

Results Overview

Cumulative percent of radioactive dose recovered in urine and feces after administration at specified intervals.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 6 participants
• Primary outcome timeframe: Screening (urine only), Day -1, Day 1 (0 to 6, 6 to 12, and 12 to 24 hours), and at 24 hour intervals thereafter until the study release criteria have been met (up to 504 hours)
• Results posted on: 2020-06-26

Participant Flow

Participant milestones

Measure	LY2623091 Single dose of 25 milligrams (mg) LY2623091 containing carbon-14 \[¹⁴C\]-LY2623091 (approximately 100 microcuries \[µCi\]) administered orally.
Overall Study STARTED	6
Overall Study Received Study Drug	6
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	LY2623091 Single dose of 25 milligrams (mg) LY2623091 containing carbon-14 \[¹⁴C\]-LY2623091 (approximately 100 microcuries \[µCi\]) administered orally.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

A Study of How the Body Breaks Down and Eliminates LY2623091

Baseline characteristics by cohort

Measure	LY2623091 n=6 Participants Single dose of 25 mg LY2623091 containing \[¹⁴C\]-LY2623091 (approximately 100 µCi) administered orally.
Age, Continuous	40 years STANDARD_DEVIATION 14.0 • 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	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 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: Screening (urine only), Day -1, Day 1 (0 to 6, 6 to 12, and 12 to 24 hours), and at 24 hour intervals thereafter until the study release criteria have been met (up to 504 hours)

Population: All participants who received study drug and had quantifiable levels of radioactivity in urine and feces.

Cumulative percent of radioactive dose recovered in urine and feces after administration at specified intervals.

Outcome measures

Measure	LY2623091 n=6 Participants Single dose of 25 mg LY2623091 containing \[¹⁴C\]-LY2623091 (approximately 100 µCi) administered orally.
Urinary and Fecal Excretion of LY2623091 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered Feces	60.5 percentage of radioactive dose recovered Standard Deviation 4.27
Urinary and Fecal Excretion of LY2623091 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered Urine	1.39 percentage of radioactive dose recovered Standard Deviation 0.454

SECONDARY outcome

Timeframe: Day 1 (predose, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose), 24 hours postdose, and every 24 hours thereafter until study release criteria have been met (up to 504 hours)

Population: All participants who received study drug and had evaluable AUC(0-tlast) values.

Outcome measures

Measure	LY2623091 n=6 Participants Single dose of 25 mg LY2623091 containing \[¹⁴C\]-LY2623091 (approximately 100 µCi) administered orally.
Plasma Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY2623091	11800 nanograms*hour/milliliter (ng*h/mL) Geometric Coefficient of Variation 38

SECONDARY outcome

Timeframe: Day 1 (predose, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose), 24 hours postdose, and every 24 hours thereafter until study release criteria have been met (up to 504 hours)

Population: All participants who received study drug and had evaluable AUC(0-inf) values.

Outcome measures

Measure	LY2623091 n=6 Participants Single dose of 25 mg LY2623091 containing \[¹⁴C\]-LY2623091 (approximately 100 µCi) administered orally.
Plasma Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY2623091	11800 ng*h/mL Geometric Coefficient of Variation 38

SECONDARY outcome

Timeframe: Day 1 (predose, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose), 24 hours postdose, and every 24 hours thereafter until study release criteria have been met (up to 504 hours)

Population: All participants who received study drug and had evaluable Cmax values.

Outcome measures

Measure	LY2623091 n=6 Participants Single dose of 25 mg LY2623091 containing \[¹⁴C\]-LY2623091 (approximately 100 µCi) administered orally.
Plasma Pharmacokinetics: Maximum Concentration (Cmax) of LY2623091	482 ng/mL Geometric Coefficient of Variation 15

SECONDARY outcome

Timeframe: Day 1 (predose, 2, 3, 4, 6, 8, and 12 hours postdose), and at 24 and 48 hours postdose

Population: All participants who received study drug and had evaluable plasma, urine, and fecal samples.

Outcome measures

Measure	LY2623091 n=6 Participants Single dose of 25 mg LY2623091 containing \[¹⁴C\]-LY2623091 (approximately 100 µCi) administered orally.
Total Number of Metabolites of LY2623091 in Plasma, Urine, and Feces Plasma	7 metabolites
Total Number of Metabolites of LY2623091 in Plasma, Urine, and Feces Urine	NA metabolites Urine was not profiled due to the low percentage of dose excreted in urine.
Total Number of Metabolites of LY2623091 in Plasma, Urine, and Feces Feces	17 metabolites

Adverse Events

LY2623091

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	LY2623091 n=6 participants at risk Single dose of 25 mg LY2623091 containing \[¹⁴C\]-LY2623091 (approximately 100 µCi) administered orally.
Gastrointestinal disorders Constipation	16.7% 1/6 • Number of events 1 Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
Gastrointestinal disorders Diarrhoea	16.7% 1/6 • Number of events 1 Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
Gastrointestinal disorders Proctalgia	16.7% 1/6 • Number of events 1 Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
General disorders Vessel puncture site bruise	16.7% 1/6 • Number of events 1 Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
Injury, poisoning and procedural complications Scratch	16.7% 1/6 • Number of events 1 Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
Musculoskeletal and connective tissue disorders Neck pain	16.7% 1/6 • Number of events 1 Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
Nervous system disorders Headache	16.7% 1/6 • Number of events 2 Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
Skin and subcutaneous tissue disorders Erythema	16.7% 1/6 • Number of events 2 Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.

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