Trial Outcomes & Findings for A Study of [¹⁴C]-LY3484356 in Healthy Female Participants (NCT NCT04991766)
NCT ID: NCT04991766
Last Updated: 2025-12-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
Predose, 24, 48, 72, 96, 120, 144, 168,192, 216, 240, 264, 288 and 312 hours post dose
Results posted on
2025-12-05
Participant Flow
This is a two-part study. Participants in Part 1 did not participate in Part 2.
Participant milestones
| Measure |
Part 1: [¹⁴C]-LY3484356
Participants received a single oral dose of 400 milligram (mg) Carbon 14 labelled \[¹⁴C\]-LY3484356 following an overnight fast of at least 10 hours on Day 1.
|
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 microgram (μg) \[¹⁴C\]-LY3484356 (actual ranged from 44.55 to 45.95 μg), as an intravenous (IV) infusion on day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
8
|
8
|
|
Overall Study
COMPLETED
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Part 1: [¹⁴C]-LY3484356
Participants received a single oral dose of 400 milligram (mg) Carbon 14 labelled \[¹⁴C\]-LY3484356 following an overnight fast of at least 10 hours on Day 1.
|
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 microgram (μg) \[¹⁴C\]-LY3484356 (actual ranged from 44.55 to 45.95 μg), as an intravenous (IV) infusion on day 1.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
A Study of [¹⁴C]-LY3484356 in Healthy Female Participants
Baseline characteristics by cohort
| Measure |
Part 1: [¹⁴C]-LY3484356
n=8 Participants
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.
|
Part 2: LY3484356 + [¹⁴C] LY3484356
n=8 Participants
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.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
|
Age, Continuous
|
52.8 years
STANDARD_DEVIATION 7.1 • n=37 Participants
|
53.3 years
STANDARD_DEVIATION 9.4 • n=37 Participants
|
53.0 years
STANDARD_DEVIATION 8.0 • n=74 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=37 Participants
|
8 Participants
n=37 Participants
|
16 Participants
n=74 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=37 Participants
|
1 Participants
n=37 Participants
|
3 Participants
n=74 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=37 Participants
|
7 Participants
n=37 Participants
|
13 Participants
n=74 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
1 Participants
n=74 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=37 Participants
|
2 Participants
n=37 Participants
|
5 Participants
n=74 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=37 Participants
|
5 Participants
n=37 Participants
|
8 Participants
n=74 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=37 Participants
|
1 Participants
n=37 Participants
|
2 Participants
n=74 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=37 Participants
|
8 Participants
n=37 Participants
|
16 Participants
n=74 Participants
|
PRIMARY outcome
Timeframe: Predose, 24, 48, 72, 96, 120, 144, 168,192, 216, 240, 264, 288 and 312 hours post dosePopulation: All enrolled participants who received at least 1 dose of \[¹⁴C\]-LY3484356 and had evaluable PK data for this outcome.
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.
Outcome measures
| Measure |
Part 1: [¹⁴C]-LY3484356
n=5 Participants
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.
|
|---|---|
|
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
Interval 90.0 to 101.0
|
PRIMARY outcome
Timeframe: Predose, 24, 48 ,72, 96, 120, 144, 168, 192, 216, 240, 264, 288 and 312 hours post dosePopulation: All enrolled participants who received at least 1 dose of \[¹⁴C\]-LY3484356 and had evaluable PK data for this outcome.
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.
Outcome measures
| Measure |
Part 1: [¹⁴C]-LY3484356
n=5 Participants
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.
|
|---|---|
|
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
Interval 0.109 to 0.497
|
PRIMARY outcome
Timeframe: 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 postdosePopulation: All enrolled participants who received at least 1 dose of LY3484356 + \[¹⁴C\]-LY3484356 and have evaluable PK data for this outcome.
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.
Outcome measures
| Measure |
Part 1: [¹⁴C]-LY3484356
n=8 Participants
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.
|
|---|---|
|
Part 2: Pharmacokinetics (PK): Percent Absolute Bioavailability (F%) of LY3484356
|
10.5 percent absolute bioavailability
Geometric Coefficient of Variation 32
|
SECONDARY outcome
Timeframe: Predose, 24, 48, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456 and 480 hours post dosePopulation: All enrolled participants who received at least 1 dose of \[¹⁴C\]-LY3484356 and had evaluable PK data for this outcome.
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).
Outcome measures
| Measure |
Part 1: [¹⁴C]-LY3484356
n=5 Participants
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.
|
|---|---|
|
Part 1: PK: Total Radioactivity Recovered in Urine, Feces
Urine Radioactivity
|
0.278 percentage of recovered radioactivity
Interval 0.109 to 0.497
|
|
Part 1: PK: Total Radioactivity Recovered in Urine, Feces
Fecal Radioactivity
|
97.3 percentage of recovered radioactivity
Interval 90.0 to 101.0
|
SECONDARY outcome
Timeframe: predose, 8, and 24 hours postdosePopulation: All enrolled participants who received at least 1 dose of \[¹⁴C\]-LY3484356 and had evaluable PK data for this outcome.
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.
Outcome measures
| Measure |
Part 1: [¹⁴C]-LY3484356
n=1 Participants
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.
|
|---|---|
|
Part 1: Total Radioactivity Recovered in Expired Air
8 hours postdose
|
53 disintegrations per minute
|
|
Part 1: Total Radioactivity Recovered in Expired Air
24 hours postdose
|
62 disintegrations per minute
|
SECONDARY outcome
Timeframe: 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 dosePopulation: All enrolled participants who received at least 1 dose of \[¹⁴C\]-LY3484356 and had evaluable PK data for this outcome.
Total number of metabolites of LY3484356 is reported. The value is an absolute number without any measure of central tendency.
Outcome measures
| Measure |
Part 1: [¹⁴C]-LY3484356
n=5 Participants
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.
|
|---|---|
|
Part 1: PK: Total Number of Metabolites of LY3484356 in Plasma, Urine and Feces
Plasma
|
3 number of metabolites
|
|
Part 1: PK: Total Number of Metabolites of LY3484356 in Plasma, Urine and Feces
Urine
|
0 number of metabolites
|
|
Part 1: PK: Total Number of Metabolites of LY3484356 in Plasma, Urine and Feces
Feces
|
7 number of metabolites
|
SECONDARY outcome
Timeframe: 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-dosePopulation: All enrolled participants who received at least 1 dose of \[¹⁴C\]-LY3484356 and had evaluable PK data for this outcome.
PK: AUC \[0-∞\] of LY3484356 in Plasma.
Outcome measures
| Measure |
Part 1: [¹⁴C]-LY3484356
n=6 Participants
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.
|
|---|---|
|
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 outcome
Timeframe: 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-dosePopulation: All enrolled participants who received at least 1 dose of \[¹⁴C\]-LY3484356 and had evaluable PK data for this outcome.
PK: AUC \[0-∞\] of Plasma Total Radioactivity. Total radioactivity is reported as nanogram\* hours equivalents per milliliter (ng\*h Eq/mL).
Outcome measures
| Measure |
Part 1: [¹⁴C]-LY3484356
n=6 Participants
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.
|
|---|---|
|
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 outcome
Timeframe: 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-dosePopulation: All enrolled participants who received at least 1 dose of \[¹⁴C\]-LY3484356 and had evaluable PK data for this outcome.
PK: Cmax for LY3484356 in plasma.
Outcome measures
| Measure |
Part 1: [¹⁴C]-LY3484356
n=6 Participants
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.
|
|---|---|
|
Part 1: PK: Maximum Concentration (Cmax) for LY3484356 in Plasma
|
108 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 48
|
SECONDARY outcome
Timeframe: 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-dosePopulation: All enrolled participants who received at least 1 dose of \[¹⁴C\]-LY3484356 and had evaluable PK data for this outcome.
PK: Cmax for total radioactivity in plasma. The Cmax of total radioactivity are reported as nanogram equivalents per milliliter (ng Eq/mL).
Outcome measures
| Measure |
Part 1: [¹⁴C]-LY3484356
n=6 Participants
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.
|
|---|---|
|
Part 1: PK: Maximum Concentration (Cmax) for Total Radioactivity in Plasma
|
537 ng Eq/mL
Geometric Coefficient of Variation 18
|
SECONDARY outcome
Timeframe: 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 postdosePopulation: All enrolled participants who received at least 1 dose of LY3484356 or \[¹⁴C\]-LY3484356 and have evaluable PK data for this outcome.
PK: AUC \[0-∞\] of Total Radioactivity. Total radioactivity is reported as hours\*nanogram equivalents per milliliter (h\*ng Eq/mL).
Outcome measures
| Measure |
Part 1: [¹⁴C]-LY3484356
n=8 Participants
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.
|
|---|---|
|
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 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 outcome
Timeframe: 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 postdosePopulation: All enrolled participants who received at least 1 dose of LY3484356 or \[¹⁴C\]-LY3484356 and have evaluable PK data for this outcome.
PK: AUC \[0-∞\] of Total Radioactivity in Plasma.
Outcome measures
| Measure |
Part 1: [¹⁴C]-LY3484356
n=8 Participants
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.
|
|---|---|
|
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 outcome
Timeframe: 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 postdosePopulation: All enrolled participants who received at least 1 dose of LY3484356 or \[¹⁴C\]-LY3484356 and have evaluable PK data for this outcome.
PK: Cmax of LY3484356 and \[¹⁴C\]-LY3484356 in plasma.
Outcome measures
| Measure |
Part 1: [¹⁴C]-LY3484356
n=8 Participants
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.
|
|---|---|
|
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 2: PK: Maximum Concentration (Cmax) for [¹⁴C]-LY3484356 and LY3484356 in Plasma
Plasma LY3484356
|
33.1 ng/mL
Geometric Coefficient of Variation 59
|
SECONDARY outcome
Timeframe: 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 postdosePopulation: All enrolled participants who received at least 1 dose of LY3484356 or \[¹⁴C\]-LY3484356 and have evaluable PK data for this outcome.
PK: Cmax of total radioactivity in plasma.
Outcome measures
| Measure |
Part 1: [¹⁴C]-LY3484356
n=8 Participants
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.
|
|---|---|
|
Part 2: PK: Maximum Concentration (Cmax) for Total Radioactivity in Plasma
|
0.857 ng Eq/mL
Geometric Coefficient of Variation 18
|
Adverse Events
Part 1: [¹⁴C]-LY3484356
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part 2: LY3484356 + [¹⁴C]-LY3484356
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1: [¹⁴C]-LY3484356
n=8 participants at risk
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.
|
Part 2: LY3484356 + [¹⁴C]-LY3484356
n=8 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/8 • Part 1: Baseline Up to Day 29, Part 2: Baseline Up to Day 16
All enrolled participants who received at least 1 dose of LY3484356 or \[14C\]-LY3484356, whether or not they completed all protocol requirements.
|
12.5%
1/8 • Number of events 1 • Part 1: Baseline Up to Day 29, Part 2: Baseline Up to Day 16
All enrolled participants who received at least 1 dose of LY3484356 or \[14C\]-LY3484356, whether or not they completed all protocol requirements.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
12.5%
1/8 • Number of events 1 • Part 1: Baseline Up to Day 29, Part 2: Baseline Up to Day 16
All enrolled participants who received at least 1 dose of LY3484356 or \[14C\]-LY3484356, whether or not they completed all protocol requirements.
|
0.00%
0/8 • Part 1: Baseline Up to Day 29, Part 2: Baseline Up to Day 16
All enrolled participants who received at least 1 dose of LY3484356 or \[14C\]-LY3484356, whether or not they completed all protocol requirements.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.5%
1/8 • Number of events 1 • Part 1: Baseline Up to Day 29, Part 2: Baseline Up to Day 16
All enrolled participants who received at least 1 dose of LY3484356 or \[14C\]-LY3484356, whether or not they completed all protocol requirements.
|
0.00%
0/8 • Part 1: Baseline Up to Day 29, Part 2: Baseline Up to Day 16
All enrolled participants who received at least 1 dose of LY3484356 or \[14C\]-LY3484356, whether or not they completed all protocol requirements.
|
|
Gastrointestinal disorders
Constipation
|
12.5%
1/8 • Number of events 1 • Part 1: Baseline Up to Day 29, Part 2: Baseline Up to Day 16
All enrolled participants who received at least 1 dose of LY3484356 or \[14C\]-LY3484356, whether or not they completed all protocol requirements.
|
0.00%
0/8 • Part 1: Baseline Up to Day 29, Part 2: Baseline Up to Day 16
All enrolled participants who received at least 1 dose of LY3484356 or \[14C\]-LY3484356, whether or not they completed all protocol requirements.
|
|
Gastrointestinal disorders
Diarrhoea
|
37.5%
3/8 • Number of events 5 • Part 1: Baseline Up to Day 29, Part 2: Baseline Up to Day 16
All enrolled participants who received at least 1 dose of LY3484356 or \[14C\]-LY3484356, whether or not they completed all protocol requirements.
|
0.00%
0/8 • Part 1: Baseline Up to Day 29, Part 2: Baseline Up to Day 16
All enrolled participants who received at least 1 dose of LY3484356 or \[14C\]-LY3484356, whether or not they completed all protocol requirements.
|
|
Gastrointestinal disorders
Haematochezia
|
12.5%
1/8 • Number of events 1 • Part 1: Baseline Up to Day 29, Part 2: Baseline Up to Day 16
All enrolled participants who received at least 1 dose of LY3484356 or \[14C\]-LY3484356, whether or not they completed all protocol requirements.
|
0.00%
0/8 • Part 1: Baseline Up to Day 29, Part 2: Baseline Up to Day 16
All enrolled participants who received at least 1 dose of LY3484356 or \[14C\]-LY3484356, whether or not they completed all protocol requirements.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
2/8 • Number of events 2 • Part 1: Baseline Up to Day 29, Part 2: Baseline Up to Day 16
All enrolled participants who received at least 1 dose of LY3484356 or \[14C\]-LY3484356, whether or not they completed all protocol requirements.
|
12.5%
1/8 • Number of events 1 • Part 1: Baseline Up to Day 29, Part 2: Baseline Up to Day 16
All enrolled participants who received at least 1 dose of LY3484356 or \[14C\]-LY3484356, whether or not they completed all protocol requirements.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
2/8 • Number of events 2 • Part 1: Baseline Up to Day 29, Part 2: Baseline Up to Day 16
All enrolled participants who received at least 1 dose of LY3484356 or \[14C\]-LY3484356, whether or not they completed all protocol requirements.
|
0.00%
0/8 • Part 1: Baseline Up to Day 29, Part 2: Baseline Up to Day 16
All enrolled participants who received at least 1 dose of LY3484356 or \[14C\]-LY3484356, whether or not they completed all protocol requirements.
|
|
General disorders
Infusion site pain
|
0.00%
0/8 • Part 1: Baseline Up to Day 29, Part 2: Baseline Up to Day 16
All enrolled participants who received at least 1 dose of LY3484356 or \[14C\]-LY3484356, whether or not they completed all protocol requirements.
|
12.5%
1/8 • Number of events 1 • Part 1: Baseline Up to Day 29, Part 2: Baseline Up to Day 16
All enrolled participants who received at least 1 dose of LY3484356 or \[14C\]-LY3484356, whether or not they completed all protocol requirements.
|
|
Infections and infestations
Pyuria
|
12.5%
1/8 • Number of events 1 • Part 1: Baseline Up to Day 29, Part 2: Baseline Up to Day 16
All enrolled participants who received at least 1 dose of LY3484356 or \[14C\]-LY3484356, whether or not they completed all protocol requirements.
|
0.00%
0/8 • Part 1: Baseline Up to Day 29, Part 2: Baseline Up to Day 16
All enrolled participants who received at least 1 dose of LY3484356 or \[14C\]-LY3484356, whether or not they completed all protocol requirements.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • Number of events 1 • Part 1: Baseline Up to Day 29, Part 2: Baseline Up to Day 16
All enrolled participants who received at least 1 dose of LY3484356 or \[14C\]-LY3484356, whether or not they completed all protocol requirements.
|
0.00%
0/8 • Part 1: Baseline Up to Day 29, Part 2: Baseline Up to Day 16
All enrolled participants who received at least 1 dose of LY3484356 or \[14C\]-LY3484356, whether or not they completed all protocol requirements.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/8 • Part 1: Baseline Up to Day 29, Part 2: Baseline Up to Day 16
All enrolled participants who received at least 1 dose of LY3484356 or \[14C\]-LY3484356, whether or not they completed all protocol requirements.
|
12.5%
1/8 • Number of events 1 • Part 1: Baseline Up to Day 29, Part 2: Baseline Up to Day 16
All enrolled participants who received at least 1 dose of LY3484356 or \[14C\]-LY3484356, whether or not they completed all protocol requirements.
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Number of events 1 • Part 1: Baseline Up to Day 29, Part 2: Baseline Up to Day 16
All enrolled participants who received at least 1 dose of LY3484356 or \[14C\]-LY3484356, whether or not they completed all protocol requirements.
|
12.5%
1/8 • Number of events 1 • Part 1: Baseline Up to Day 29, Part 2: Baseline Up to Day 16
All enrolled participants who received at least 1 dose of LY3484356 or \[14C\]-LY3484356, whether or not they completed all protocol requirements.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60