Healthy
Conditions
Keywords
Metabolism, Absolute Bioavailability, Disposition
Brief summary
The main purpose of this study is to measure how much of the study drug gets into the bloodstream and how long it takes the body to get rid of it. This study has two parts. It will involve a single dose of 14C radiolabeled LY3484356. This means that a radioactive substance C14 will be incorporated into the study drug, to investigate the study drug and its breakdown products, to find out how much of these pass from blood into urine, feces and expired air. The study will last about 4 weeks. Screening is required within 28 days prior to the start of the study and follow up is required approximately 7 days after discharge.
Interventions
DRUG[¹⁴C]-LY3484356
Administered orally.
DRUGLY3484356
Administered orally.
DRUG[¹⁴C]-LY3484356 (IV)
Administered IV.
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Female participants of nonchildbearing potential. This includes females who are not pregnant, non-lactating and either: Infertile due to surgical sterilization or alternate medical cause/congenital or postmenopausal. * Body mass index (BMI) within the range of 18.0 to 35.0 kilograms per meter squared (kg/m²)
Exclusion criteria
* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorders * Have evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies * Have known allergies to LY3484356, related compounds or any components of the formulation as appropriate, or history of significant atopy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Pharmacokinetics (PK): Fecal Excretion of LY3484356 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Predose, 24, 48, 72, 96, 120, 144, 168,192, 216, 240, 264, 288 and 312 hours post dose | The percentage of the total radioactive dose administered that was excreted in feces = (amount of radioactive dose recovered in feces / total radioactive dose administered) \* 100. |
| Part 1: PK: Urinary Excretion of LY3484356 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Predose, 24, 48 ,72, 96, 120, 144, 168, 192, 216, 240, 264, 288 and 312 hours post dose | The percentage of the total radioactive dose administered that was excreted in urine = (amount of radioactive dose recovered in urine / total radioactive dose administered) \* 100. |
| Part 2: Pharmacokinetics (PK): Percent Absolute Bioavailability (F%) of LY3484356 | Predose, 5 minutes(min), 15 min, 20 min, 30 min, 45 min, and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours postdose | PK: Bioavailability is defined as the percentage of a drug which enters the circulation when introduced into the body and so is able to have an active effect. Percent absolute bioavailability, calculated for plasma LY3484356 as F %= \[AUC (0-∞), LY3484356\] × \[Dose, \[14C\]-LY3484356\] / \[AUC (0-∞), \[14C\]-LY3484356\] × \[Dose, LY3484356\] ×100%'' Higher percent indicates better absorption of drug into the body. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Total Radioactivity Recovered in Expired Air | predose, 8, and 24 hours postdose | Radioactivity is expressed in becquerels (Bq), the International System of Unit (SI) representing one nuclear disintegration per second. For practical measurement, total radioactivity recovered in expired air is reported in disintegrations per minute (dpm). The conversion factor is: 1 Bq = 60 dpm. |
| Part 1: PK: Total Number of Metabolites of LY3484356 in Plasma, Urine and Feces | Plasma:Predose,24,48,72,96,120,144,168,192,216,240,264 and 288 hours(h) post dose;Urine:-12 to 0h Predose,0 to 6,6-12,and 12-24,48,72,96,120,144,168,192,216,240 and 264 hours post dose;Feces:Predose,24,48,72,96,120,144, 168,192,216,240 and 264 h post dose | Total number of metabolites of LY3484356 is reported. The value is an absolute number without any measure of central tendency. |
| Part 1: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for LY3484356 in Plasma | Part 1: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8,10, 12, 24, 48, 72, 96,120, 144, 168, 192, 216, 240, and 264 hours post-dose | PK: AUC \[0-∞\] of LY3484356 in Plasma. |
| Part 1: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for Total Radioactivity in Plasma | Part 1: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8,10, 12, 24, 48, 72, 96,120, 144, 168, 192, 216, 240, and 264 hours post-dose | PK: AUC \[0-∞\] of Plasma Total Radioactivity. Total radioactivity is reported as nanogram\* hours equivalents per milliliter (ng\*h Eq/mL). |
| Part 1: PK: Total Radioactivity Recovered in Urine, Feces | Predose, 24, 48, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456 and 480 hours post dose | Relative abundance was expressed and calculated as the percentage of administered dose excreted in urine/Feces=\[(percentage of radioactivity in peak)/100\]\*(percentage of dose in sample). |
| Part 1: PK: Maximum Concentration (Cmax) for Total Radioactivity in Plasma | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8,10, 12, 24, 48, 72, 96,120, 144, 168, 192, 216, 240, and 264 hours post-dose | PK: Cmax for total radioactivity in plasma. The Cmax of total radioactivity are reported as nanogram equivalents per milliliter (ng Eq/mL). |
| Part 2: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for [¹⁴C]-LY3484356 and LY3484356 in Plasma | Predose, 5 minutes(min), 15 min, 20 min, 30 min, 45 min, and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours postdose | PK: AUC \[0-∞\] of Total Radioactivity. Total radioactivity is reported as hours\*nanogram equivalents per milliliter (h\*ng Eq/mL). |
| Part 2: PK: Maximum Concentration (Cmax) for Total Radioactivity in Plasma | Predose, 5 minutes(min), 15 min, 20 min, 30 min, 45 min, and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours postdose | PK: Cmax of total radioactivity in plasma. |
| Part 1: PK: Maximum Concentration (Cmax) for LY3484356 in Plasma | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8,10, 12, 24, 48, 72, 96,120, 144, 168, 192, 216, 240, and 264 hours post-dose | PK: Cmax for LY3484356 in plasma. |
| Part 2: PK: Maximum Concentration (Cmax) for [¹⁴C]-LY3484356 and LY3484356 in Plasma | Predose, 5 minutes(min), 15 min, 20 min, 30 min, 45 min, and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours postdose | PK: Cmax of LY3484356 and \[¹⁴C\]-LY3484356 in plasma. |
| Part 2: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for Total Radioactivity in Plasma | Predose, 5 minutes(min), 15 min, 20 min, 30 min, 45 min, and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours postdose | PK: AUC \[0-∞\] of Total Radioactivity in Plasma. |
Countries
United States
Participant flow
Pre-assignment details
This is a two-part study. Participants in Part 1 did not participate in Part 2.
Participants by arm
| Arm | Count |
|---|---|
| Part 1: [¹⁴C]-LY3484356 Participants received a single oral dose of 400 mg Carbon 14 labelled \[¹⁴C\]-LY3484356 following an overnight fast of at least 10 hours on Day 1. | 8 |
| Part 2: LY3484356 + [¹⁴C] LY3484356 Participants received a single oral dose of 400 mg LY3484356 following an overnight fast of at least 10 hours on Day 1, followed 4 hours later by a single dose of less than 100 μg \[¹⁴C\]-LY3484356 (actual ranged from 44.55 to 45.95 μg), as an IV infusion on day 1. | 8 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Part 1: [¹⁴C]-LY3484356 | Total | Part 2: LY3484356 + [¹⁴C] LY3484356 |
|---|---|---|---|
| Age, Continuous | 52.8 years STANDARD_DEVIATION 7.1 | 53.0 years STANDARD_DEVIATION 8 | 53.3 years STANDARD_DEVIATION 9.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 13 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 8 Participants | 5 Participants |
| Region of Enrollment United States | 8 Participants | 16 Participants | 8 Participants |
| Sex: Female, Male Female | 8 Participants | 16 Participants | 8 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 8 / 8 | 3 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 |
Outcome results
Primary
Part 1: Pharmacokinetics (PK): Fecal Excretion of LY3484356 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
The percentage of the total radioactive dose administered that was excreted in feces = (amount of radioactive dose recovered in feces / total radioactive dose administered) \* 100.
Time frame: Predose, 24, 48, 72, 96, 120, 144, 168,192, 216, 240, 264, 288 and 312 hours post dose
Population: All enrolled participants who received at least 1 dose of \[¹⁴C\]-LY3484356 and had evaluable PK data for this outcome.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Part 1: [¹⁴C]-LY3484356 | Part 1: Pharmacokinetics (PK): Fecal Excretion of LY3484356 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | 97.3 percentage of the total radioactive dose |
Primary
Part 1: PK: Urinary Excretion of LY3484356 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
The percentage of the total radioactive dose administered that was excreted in urine = (amount of radioactive dose recovered in urine / total radioactive dose administered) \* 100.
Time frame: Predose, 24, 48 ,72, 96, 120, 144, 168, 192, 216, 240, 264, 288 and 312 hours post dose
Population: All enrolled participants who received at least 1 dose of \[¹⁴C\]-LY3484356 and had evaluable PK data for this outcome.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Part 1: [¹⁴C]-LY3484356 | Part 1: PK: Urinary Excretion of LY3484356 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | 0.278 percentage of the total radioactive dose |
Primary
Part 2: Pharmacokinetics (PK): Percent Absolute Bioavailability (F%) of LY3484356
PK: Bioavailability is defined as the percentage of a drug which enters the circulation when introduced into the body and so is able to have an active effect. Percent absolute bioavailability, calculated for plasma LY3484356 as F %= \[AUC (0-∞), LY3484356\] × \[Dose, \[14C\]-LY3484356\] / \[AUC (0-∞), \[14C\]-LY3484356\] × \[Dose, LY3484356\] ×100%'' Higher percent indicates better absorption of drug into the body.
Time frame: Predose, 5 minutes(min), 15 min, 20 min, 30 min, 45 min, and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours postdose
Population: All enrolled participants who received at least 1 dose of LY3484356 + \[¹⁴C\]-LY3484356 and have evaluable PK data for this outcome.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: [¹⁴C]-LY3484356 | Part 2: Pharmacokinetics (PK): Percent Absolute Bioavailability (F%) of LY3484356 | 10.5 percent absolute bioavailability | Geometric Coefficient of Variation 32 |
Secondary
Part 1: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for LY3484356 in Plasma
PK: AUC \[0-∞\] of LY3484356 in Plasma.
Time frame: Part 1: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8,10, 12, 24, 48, 72, 96,120, 144, 168, 192, 216, 240, and 264 hours post-dose
Population: All enrolled participants who received at least 1 dose of \[¹⁴C\]-LY3484356 and had evaluable PK data for this outcome.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: [¹⁴C]-LY3484356 | Part 1: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for LY3484356 in Plasma | 3130 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 38 |
Secondary
Part 1: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for Total Radioactivity in Plasma
PK: AUC \[0-∞\] of Plasma Total Radioactivity. Total radioactivity is reported as nanogram\* hours equivalents per milliliter (ng\*h Eq/mL).
Time frame: Part 1: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8,10, 12, 24, 48, 72, 96,120, 144, 168, 192, 216, 240, and 264 hours post-dose
Population: All enrolled participants who received at least 1 dose of \[¹⁴C\]-LY3484356 and had evaluable PK data for this outcome.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: [¹⁴C]-LY3484356 | Part 1: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for Total Radioactivity in Plasma | 17900 ng*h Eq/mL | Geometric Coefficient of Variation 39 |
Secondary
Part 1: PK: Maximum Concentration (Cmax) for LY3484356 in Plasma
PK: Cmax for LY3484356 in plasma.
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8,10, 12, 24, 48, 72, 96,120, 144, 168, 192, 216, 240, and 264 hours post-dose
Population: All enrolled participants who received at least 1 dose of \[¹⁴C\]-LY3484356 and had evaluable PK data for this outcome.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: [¹⁴C]-LY3484356 | Part 1: PK: Maximum Concentration (Cmax) for LY3484356 in Plasma | 108 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 48 |
Secondary
Part 1: PK: Maximum Concentration (Cmax) for Total Radioactivity in Plasma
PK: Cmax for total radioactivity in plasma. The Cmax of total radioactivity are reported as nanogram equivalents per milliliter (ng Eq/mL).
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8,10, 12, 24, 48, 72, 96,120, 144, 168, 192, 216, 240, and 264 hours post-dose
Population: All enrolled participants who received at least 1 dose of \[¹⁴C\]-LY3484356 and had evaluable PK data for this outcome.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: [¹⁴C]-LY3484356 | Part 1: PK: Maximum Concentration (Cmax) for Total Radioactivity in Plasma | 537 ng Eq/mL | Geometric Coefficient of Variation 18 |
Secondary
Part 1: PK: Total Number of Metabolites of LY3484356 in Plasma, Urine and Feces
Total number of metabolites of LY3484356 is reported. The value is an absolute number without any measure of central tendency.
Time frame: Plasma:Predose,24,48,72,96,120,144,168,192,216,240,264 and 288 hours(h) post dose;Urine:-12 to 0h Predose,0 to 6,6-12,and 12-24,48,72,96,120,144,168,192,216,240 and 264 hours post dose;Feces:Predose,24,48,72,96,120,144, 168,192,216,240 and 264 h post dose
Population: All enrolled participants who received at least 1 dose of \[¹⁴C\]-LY3484356 and had evaluable PK data for this outcome.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: [¹⁴C]-LY3484356 | Part 1: PK: Total Number of Metabolites of LY3484356 in Plasma, Urine and Feces | Plasma | 3 number of metabolites |
| Part 1: [¹⁴C]-LY3484356 | Part 1: PK: Total Number of Metabolites of LY3484356 in Plasma, Urine and Feces | Urine | 0 number of metabolites |
| Part 1: [¹⁴C]-LY3484356 | Part 1: PK: Total Number of Metabolites of LY3484356 in Plasma, Urine and Feces | Feces | 7 number of metabolites |
Secondary
Part 1: PK: Total Radioactivity Recovered in Urine, Feces
Relative abundance was expressed and calculated as the percentage of administered dose excreted in urine/Feces=\[(percentage of radioactivity in peak)/100\]\*(percentage of dose in sample).
Time frame: Predose, 24, 48, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456 and 480 hours post dose
Population: All enrolled participants who received at least 1 dose of \[¹⁴C\]-LY3484356 and had evaluable PK data for this outcome.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Part 1: [¹⁴C]-LY3484356 | Part 1: PK: Total Radioactivity Recovered in Urine, Feces | Urine Radioactivity | 0.278 percentage of recovered radioactivity |
| Part 1: [¹⁴C]-LY3484356 | Part 1: PK: Total Radioactivity Recovered in Urine, Feces | Fecal Radioactivity | 97.3 percentage of recovered radioactivity |
Secondary
Part 1: Total Radioactivity Recovered in Expired Air
Radioactivity is expressed in becquerels (Bq), the International System of Unit (SI) representing one nuclear disintegration per second. For practical measurement, total radioactivity recovered in expired air is reported in disintegrations per minute (dpm). The conversion factor is: 1 Bq = 60 dpm.
Time frame: predose, 8, and 24 hours postdose
Population: All enrolled participants who received at least 1 dose of \[¹⁴C\]-LY3484356 and had evaluable PK data for this outcome.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: [¹⁴C]-LY3484356 | Part 1: Total Radioactivity Recovered in Expired Air | 8 hours postdose | 53 disintegrations per minute |
| Part 1: [¹⁴C]-LY3484356 | Part 1: Total Radioactivity Recovered in Expired Air | 24 hours postdose | 62 disintegrations per minute |
Secondary
Part 2: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for [¹⁴C]-LY3484356 and LY3484356 in Plasma
PK: AUC \[0-∞\] of Total Radioactivity. Total radioactivity is reported as hours\*nanogram equivalents per milliliter (h\*ng Eq/mL).
Time frame: Predose, 5 minutes(min), 15 min, 20 min, 30 min, 45 min, and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours postdose
Population: All enrolled participants who received at least 1 dose of LY3484356 or \[¹⁴C\]-LY3484356 and have evaluable PK data for this outcome.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: [¹⁴C]-LY3484356 | Part 2: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for [¹⁴C]-LY3484356 and LY3484356 in Plasma | Plasma [14C]-LY3484356 | 1.95 ng*hr/mL | Geometric Coefficient of Variation 26 |
| Part 1: [¹⁴C]-LY3484356 | Part 2: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for [¹⁴C]-LY3484356 and LY3484356 in Plasma | Plasma LY3484356 | 1810 ng*hr/mL | Geometric Coefficient of Variation 45 |
Secondary
Part 2: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for Total Radioactivity in Plasma
PK: AUC \[0-∞\] of Total Radioactivity in Plasma.
Time frame: Predose, 5 minutes(min), 15 min, 20 min, 30 min, 45 min, and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours postdose
Population: All enrolled participants who received at least 1 dose of LY3484356 or \[¹⁴C\]-LY3484356 and have evaluable PK data for this outcome.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: [¹⁴C]-LY3484356 | Part 2: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for Total Radioactivity in Plasma | 7.44 ng*h Eq/mL | Geometric Coefficient of Variation 18 |
Secondary
Part 2: PK: Maximum Concentration (Cmax) for [¹⁴C]-LY3484356 and LY3484356 in Plasma
PK: Cmax of LY3484356 and \[¹⁴C\]-LY3484356 in plasma.
Time frame: Predose, 5 minutes(min), 15 min, 20 min, 30 min, 45 min, and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours postdose
Population: All enrolled participants who received at least 1 dose of LY3484356 or \[¹⁴C\]-LY3484356 and have evaluable PK data for this outcome.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: [¹⁴C]-LY3484356 | Part 2: PK: Maximum Concentration (Cmax) for [¹⁴C]-LY3484356 and LY3484356 in Plasma | Plasma [14C]-LY3484356 | 0.575 ng/mL | Geometric Coefficient of Variation 21 |
| Part 1: [¹⁴C]-LY3484356 | Part 2: PK: Maximum Concentration (Cmax) for [¹⁴C]-LY3484356 and LY3484356 in Plasma | Plasma LY3484356 | 33.1 ng/mL | Geometric Coefficient of Variation 59 |
Secondary
Part 2: PK: Maximum Concentration (Cmax) for Total Radioactivity in Plasma
PK: Cmax of total radioactivity in plasma.
Time frame: Predose, 5 minutes(min), 15 min, 20 min, 30 min, 45 min, and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours postdose
Population: All enrolled participants who received at least 1 dose of LY3484356 or \[¹⁴C\]-LY3484356 and have evaluable PK data for this outcome.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: [¹⁴C]-LY3484356 | Part 2: PK: Maximum Concentration (Cmax) for Total Radioactivity in Plasma | 0.857 ng Eq/mL | Geometric Coefficient of Variation 18 |