Trial Outcomes & Findings for A Study of LY3502970 in Healthy Male Participants (NCT NCT04680767)
NCT ID: NCT04680767
Last Updated: 2026-05-26
Results Overview
Feces excretion of LY3502970 radioactivity over time expressed as a percentage of the total radioactive dose administered. Feces samples collected from 0 hour (h), where 0h = time of dose administration, through 384h postdose were used to assess this outcome.
COMPLETED
PHASE1
6 participants
0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, and 384 hours (h) postdose
2026-05-26
Participant Flow
Participant milestones
| Measure |
3mg [¹⁴C]-LY3502970
Participants received a single oral dose of 3 milligrams (mg) of carbon-14-labeled \[¹⁴C\]-LY3502970, containing approximately 200 microcuries (µCi) of radioactivity on Day 1.
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|---|---|
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Overall Study
STARTED
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6
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Overall Study
Received at Least One Dose of Study Drug
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6
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Overall Study
COMPLETED
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6
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of LY3502970 in Healthy Male Participants
Baseline characteristics by cohort
| Measure |
3mg [¹⁴C]-LY3502970
n=6 Participants
Participants received a single oral dose of 3mg of carbon-14-labeled \[¹⁴C\]-LY3502970, containing approximately 200 µCi of radioactivity on Day 1.
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Age, Continuous
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42.8 years
STANDARD_DEVIATION 8.0 • n=20 Participants
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Sex: Female, Male
Female
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0 Participants
n=20 Participants
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Sex: Female, Male
Male
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6 Participants
n=20 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=20 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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0 Participants
n=20 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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6 Participants
n=20 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=20 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=20 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=20 Participants
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Race (NIH/OMB)
Black or African American
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1 Participants
n=20 Participants
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Race (NIH/OMB)
White
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5 Participants
n=20 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=20 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=20 Participants
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Region of Enrollment
United Kingdom
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6 Participants
n=20 Participants
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PRIMARY outcome
Timeframe: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, and 384 hours (h) postdosePopulation: All enrolled participants who received at least one dose of study drug and had evaluable data for this outcome.
Feces excretion of LY3502970 radioactivity over time expressed as a percentage of the total radioactive dose administered. Feces samples collected from 0 hour (h), where 0h = time of dose administration, through 384h postdose were used to assess this outcome.
Outcome measures
| Measure |
3mg [¹⁴C]-LY3502970
n=6 Participants
Participants received a single oral dose of 3mg of carbon-14-labeled \[¹⁴C\]-LY3502970, containing approximately 200 µCi of radioactivity on Day 1.
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|---|---|
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Feces Excretion of LY3502970 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
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86.75 percentage of the total radioactive dose
Standard Deviation 2.78
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PRIMARY outcome
Timeframe: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, and 384 hours (h) postdosePopulation: All enrolled participants who received at least one dose of study drug and had evaluable data for this outcome.
Urinary excretion of LY3502970 radioactivity over time expressed as a percentage of the total radioactive dose administered. Urine samples collected from 0 hour (h), where 0h = time of dose administration, through 384h postdose were used to assess this outcome.
Outcome measures
| Measure |
3mg [¹⁴C]-LY3502970
n=6 Participants
Participants received a single oral dose of 3mg of carbon-14-labeled \[¹⁴C\]-LY3502970, containing approximately 200 µCi of radioactivity on Day 1.
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Urinary Excretion of LY3502970 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
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0.24 percentage of the total radioactive dose
Standard Deviation 0.02
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SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384 hours (h) postdosePopulation: All enrolled participants who received at least one dose of study drug and had evaluable PK data for this outcome. Participants were excluded from the analysis if they experienced vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).
PK: AUC0-tlast of plasma LY3502970
Outcome measures
| Measure |
3mg [¹⁴C]-LY3502970
n=5 Participants
Participants received a single oral dose of 3mg of carbon-14-labeled \[¹⁴C\]-LY3502970, containing approximately 200 µCi of radioactivity on Day 1.
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Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve t, Where t is the Last Time Point With a Measurable Concentration (AUC0- Tlast) of Plasma LY3502970
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210 nanogram*hour per milliliter(ng*h/mL)
Geometric Coefficient of Variation 14
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SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384 hours (h) postdosePopulation: All enrolled participants who received at least one dose of study drug and had evaluable PK data for this outcome. Participants were excluded from the analysis if they experienced vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).
PK: AUC0-tlast of total radioactivity in plasma and whole blood
Outcome measures
| Measure |
3mg [¹⁴C]-LY3502970
n=5 Participants
Participants received a single oral dose of 3mg of carbon-14-labeled \[¹⁴C\]-LY3502970, containing approximately 200 µCi of radioactivity on Day 1.
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PK: Area Under the Concentration Versus Time Curve t, Where t is the Last Time Point With a Measurable Concentration ((AUC0- Tlast) of Total Radioactivity in Plasma and Whole Blood
AUC0-tlast of Plasma Total Radioactivity
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266 nanogram equivalents*hour per milliliter
Geometric Coefficient of Variation 21
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PK: Area Under the Concentration Versus Time Curve t, Where t is the Last Time Point With a Measurable Concentration ((AUC0- Tlast) of Total Radioactivity in Plasma and Whole Blood
AUC0-tlast of Whole Blood Total Radioactivity
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103 nanogram equivalents*hour per milliliter
Geometric Coefficient of Variation 19
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SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384 hours (h) postdosePopulation: All enrolled participants who received at least one dose of study drug and had evaluable PK data for this outcome. Participants were excluded from the analysis if they experienced vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).
PK: AUC(0-∞) of plasma LY3502970
Outcome measures
| Measure |
3mg [¹⁴C]-LY3502970
n=5 Participants
Participants received a single oral dose of 3mg of carbon-14-labeled \[¹⁴C\]-LY3502970, containing approximately 200 µCi of radioactivity on Day 1.
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PK: Area Under the Concentration-Time Curve From Time Zero to Infinity [AUC (0-∞)] of Plasma LY3502970
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223 nanogram*hour per milliliter(ng*h/mL)
Geometric Coefficient of Variation 13
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SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384 hours (h) postdosePopulation: All enrolled participants who received at least one dose of study drug and had evaluable PK data for this outcome. Participants were excluded from the analysis if they experienced vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).
PK: AUC(0-∞) of total radioactivity in plasma and whole blood
Outcome measures
| Measure |
3mg [¹⁴C]-LY3502970
n=5 Participants
Participants received a single oral dose of 3mg of carbon-14-labeled \[¹⁴C\]-LY3502970, containing approximately 200 µCi of radioactivity on Day 1.
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|---|---|
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PK: Area Under the Concentration-Time Curve From Time Zero to Infinity [AUC (0-∞)] of Total Radioactivity in Plasma and Whole Blood
AUC(0-∞) of Plasma Total Radioactivity
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292 nanogram equivalents*hour per milliliter
Geometric Coefficient of Variation 21
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PK: Area Under the Concentration-Time Curve From Time Zero to Infinity [AUC (0-∞)] of Total Radioactivity in Plasma and Whole Blood
AUC(0-∞) of Whole Blood Total Radioactivity
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135 nanogram equivalents*hour per milliliter
Geometric Coefficient of Variation 17
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SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384 hours (h) postdosePopulation: All enrolled participants who received at least one dose of study drug and had evaluable PK data for this outcome. Participants were excluded from the analysis if they experienced vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).
PK: Cmax of plasma LY3502970
Outcome measures
| Measure |
3mg [¹⁴C]-LY3502970
n=5 Participants
Participants received a single oral dose of 3mg of carbon-14-labeled \[¹⁴C\]-LY3502970, containing approximately 200 µCi of radioactivity on Day 1.
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PK: Maximum Concentration (Cmax) of Plasma LY3502970
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10.4 nanogram per milliliter(ng/mL)
Geometric Coefficient of Variation 14
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SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384 hours (h) postdosePopulation: All enrolled participants who received at least one dose of study drug and had evaluable PK data for this outcome. Participants were excluded from the analysis if they experienced vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).
PK: Cmax of total radioactivity in plasma and whole blood
Outcome measures
| Measure |
3mg [¹⁴C]-LY3502970
n=5 Participants
Participants received a single oral dose of 3mg of carbon-14-labeled \[¹⁴C\]-LY3502970, containing approximately 200 µCi of radioactivity on Day 1.
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|---|---|
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PK: Maximum Concentration (Cmax) of Total Radioactivity in Plasma and Whole Blood
Cmax of Plasma Total Radioactivity
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10.7 nanogram equivalents per milliliter
Geometric Coefficient of Variation 17
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PK: Maximum Concentration (Cmax) of Total Radioactivity in Plasma and Whole Blood
Cmax of Whole Blood Total Radioactivity
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5.92 nanogram equivalents per milliliter
Geometric Coefficient of Variation 16
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SECONDARY outcome
Timeframe: Plasma: 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 h postdose; Urine: -12 to 0, 0-6, 6-12, 12-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, 168-192, 192-216, 216-240, 240-264, 264-288, 288-312, 312-336, 336-360, 360-384h postdosePopulation: All enrolled participants who received at least one dose of study drug and had evaluable data for this outcome.
* Total number of metabolites of LY3502970 in plasma, urine and feces samples pooled across participants to assess the presence of metabolites. * Urine and feces samples collected as a 12-hour predose interval (-12 to 0 hour \[h\], where 0h = time of dose administration) and then continuously postdose in specified intervals through 384h were used to assess this outcome. * Feces Sample collection time frame : -12 to 0, 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, 168-192, 192-216, 216-240, 240-264, 264-288, 288-312, 312-336, 336-360, 360-384h postdose
Outcome measures
| Measure |
3mg [¹⁴C]-LY3502970
n=6 Participants
Participants received a single oral dose of 3mg of carbon-14-labeled \[¹⁴C\]-LY3502970, containing approximately 200 µCi of radioactivity on Day 1.
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Total Number of Metabolites of LY3502970 in Plasma, Urine and Feces
Plasma
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2 number of metabolites
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Total Number of Metabolites of LY3502970 in Plasma, Urine and Feces
Urine
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NA number of metabolites
Urine metabolite profiling was not performed due to low percentage of radioactive dose excreted in urine, which was insufficient for reliable metabolite identification to assess this endpoint.
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Total Number of Metabolites of LY3502970 in Plasma, Urine and Feces
Feces
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12 number of metabolites
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Adverse Events
3mg [¹⁴C]-LY3502970
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
3mg [¹⁴C]-LY3502970
n=6 participants at risk
Participants received a single oral dose of 3mg of carbon-14-labeled \[¹⁴C\]-LY3502970, containing approximately 200 µCi of radioactivity on Day 1.
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Gastrointestinal disorders
Abdominal distension
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33.3%
2/6 • Number of events 2 • Baseline up to Day 26
All enrolled participants who received at least one dose of study drug.
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Gastrointestinal disorders
Abdominal pain
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16.7%
1/6 • Number of events 1 • Baseline up to Day 26
All enrolled participants who received at least one dose of study drug.
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Gastrointestinal disorders
Diarrhoea
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33.3%
2/6 • Number of events 2 • Baseline up to Day 26
All enrolled participants who received at least one dose of study drug.
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Gastrointestinal disorders
Nausea
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83.3%
5/6 • Number of events 5 • Baseline up to Day 26
All enrolled participants who received at least one dose of study drug.
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Gastrointestinal disorders
Vomiting
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33.3%
2/6 • Number of events 5 • Baseline up to Day 26
All enrolled participants who received at least one dose of study drug.
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General disorders
Vessel puncture site bruise
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16.7%
1/6 • Number of events 1 • Baseline up to Day 26
All enrolled participants who received at least one dose of study drug.
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Metabolism and nutrition disorders
Decreased appetite
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33.3%
2/6 • Number of events 2 • Baseline up to Day 26
All enrolled participants who received at least one dose of study drug.
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Nervous system disorders
Dizziness
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16.7%
1/6 • Number of events 1 • Baseline up to Day 26
All enrolled participants who received at least one dose of study drug.
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Nervous system disorders
Head discomfort
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16.7%
1/6 • Number of events 1 • Baseline up to Day 26
All enrolled participants who received at least one dose of study drug.
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Nervous system disorders
Headache
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16.7%
1/6 • Number of events 1 • Baseline up to Day 26
All enrolled participants who received at least one dose of study drug.
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Nervous system disorders
Presyncope
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16.7%
1/6 • Number of events 1 • Baseline up to Day 26
All enrolled participants who received at least one dose of study drug.
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Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
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16.7%
1/6 • Number of events 1 • Baseline up to Day 26
All enrolled participants who received at least one dose of study drug.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60