Trial Outcomes & Findings for A Study of the Effect of Food on Selpercatinib (LY3527723) in Healthy Participants (NCT NCT05324124)
NCT ID: NCT05324124
Last Updated: 2025-03-21
Results Overview
PK: AUC\[0-∞\] of Selpercatinib'
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
46 participants
Primary outcome timeframe
PK: Day 1 and Day 8: Predose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, and 72 hours (h) postdose;
Results posted on
2025-03-21
Participant Flow
Participant milestones
| Measure |
Selpercatinib Fasted/Fed
160 milligrams (mg) Selpercatinib will be administered orally on Day 1 in fasted state and on Day 8 in fed state.
|
Selpercatinib Fed/Fasted
160 mg Selpercatinib will be administered orally on Day 1 in fed state and on Day 8 in fasted state.
|
|---|---|---|
|
Period 1
STARTED
|
23
|
23
|
|
Period 1
Received One Dose of Study Drug
|
23
|
23
|
|
Period 1
COMPLETED
|
22
|
22
|
|
Period 1
NOT COMPLETED
|
1
|
1
|
|
Period 2
STARTED
|
22
|
22
|
|
Period 2
COMPLETED
|
22
|
22
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Selpercatinib Fasted/Fed
160 milligrams (mg) Selpercatinib will be administered orally on Day 1 in fasted state and on Day 8 in fed state.
|
Selpercatinib Fed/Fasted
160 mg Selpercatinib will be administered orally on Day 1 in fed state and on Day 8 in fasted state.
|
|---|---|---|
|
Period 1
Withdrawal by Subject
|
1
|
0
|
|
Period 1
Physician Decision
|
0
|
1
|
Baseline Characteristics
A Study of the Effect of Food on Selpercatinib (LY3527723) in Healthy Participants
Baseline characteristics by cohort
| Measure |
Selpercatinib
n=46 Participants
160 mg Selpercatinib will be administered orally on Day 1 in fasted state or fed state and on Day 8 in fed state or fasted state.
|
|---|---|
|
Age, Continuous
|
40.6 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 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
|
45 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 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
Singapore
|
46 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: PK: Day 1 and Day 8: Predose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, and 72 hours (h) postdose;Population: All participants who received doses of study drug on Day 1 and Day 8 and had evaluable PK data.
PK: AUC\[0-∞\] of Selpercatinib'
Outcome measures
| Measure |
Selpercatinib Fasted (Reference)
n=44 Participants
160 mg Selpercatinib administered orally in fasted state.
|
Selpercatinib Fed (Test)
n=44 Participants
160 mg Selpercatinib administered orally in fed state.
|
|---|---|---|
|
Pharmacokinetics(PK): Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Selpercatinib
|
23400 nanogram * hour per milliliter (ng*hr/mL
Geometric Coefficient of Variation 32
|
22500 nanogram * hour per milliliter (ng*hr/mL
Geometric Coefficient of Variation 44
|
PRIMARY outcome
Timeframe: PK: Day 1 and Day 8: Predose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, and 72 hours (h) postdose;Population: All participants who received doses of study drug on Day 1 and Day 8 and had evaluable PK data.
PK: AUC\[0-tlast\] of Selpercatinib
Outcome measures
| Measure |
Selpercatinib Fasted (Reference)
n=44 Participants
160 mg Selpercatinib administered orally in fasted state.
|
Selpercatinib Fed (Test)
n=44 Participants
160 mg Selpercatinib administered orally in fed state.
|
|---|---|---|
|
PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Selpercatinib
|
22700 ng*hr/mL
Geometric Coefficient of Variation 32
|
21700 ng*hr/mL
Geometric Coefficient of Variation 46
|
PRIMARY outcome
Timeframe: PK: Day 1 and Day 8: Predose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, and 72 hours (h) postdose;Population: All participants who received doses of study drug on Day 1 and Day 8 and had evaluable PK data.
PK: Cmax of Selpercatinib.
Outcome measures
| Measure |
Selpercatinib Fasted (Reference)
n=44 Participants
160 mg Selpercatinib administered orally in fasted state.
|
Selpercatinib Fed (Test)
n=44 Participants
160 mg Selpercatinib administered orally in fed state.
|
|---|---|---|
|
PK: Maximum Concentration (Cmax) of Selpercatinib
|
1840 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 39
|
1540 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 45
|
Adverse Events
160 mg Selpercatinib Fasted
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
160 mg Selpercatinib Fed
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
160 mg Selpercatinib Fasted
n=45 participants at risk
160 milligrams (mg) Selpercatinib will be administered orally on Day 1 in fasted state and on Day 8 in fed state.
|
160 mg Selpercatinib Fed
n=45 participants at risk
160 mg Selpercatinib will be administered orally on Day 1 in fed state and on Day 8 in fasted state.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
15.6%
7/45 • Number of events 11 • Screening up to 21 days
All participants who received at least one dose of study drug.
|
11.1%
5/45 • Number of events 13 • Screening up to 21 days
All participants who received at least one dose of study drug.
|
|
General disorders
Catheter site bruise
|
15.6%
7/45 • Number of events 7 • Screening up to 21 days
All participants who received at least one dose of study drug.
|
8.9%
4/45 • Number of events 4 • Screening up to 21 days
All participants who received at least one dose of study drug.
|
|
General disorders
Catheter site erythema
|
26.7%
12/45 • Number of events 12 • Screening up to 21 days
All participants who received at least one dose of study drug.
|
28.9%
13/45 • Number of events 14 • Screening up to 21 days
All participants who received at least one dose of study drug.
|
|
General disorders
Catheter site pain
|
22.2%
10/45 • Number of events 13 • Screening up to 21 days
All participants who received at least one dose of study drug.
|
13.3%
6/45 • Number of events 8 • Screening up to 21 days
All participants who received at least one dose of study drug.
|
|
General disorders
Catheter site swelling
|
6.7%
3/45 • Number of events 7 • Screening up to 21 days
All participants who received at least one dose of study drug.
|
6.7%
3/45 • Number of events 3 • Screening up to 21 days
All participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
8.9%
4/45 • Number of events 4 • Screening up to 21 days
All participants who received at least one dose of study drug.
|
6.7%
3/45 • Number of events 3 • Screening up to 21 days
All participants who received at least one dose of study drug.
|
|
General disorders
Vessel puncture site bruise
|
6.7%
3/45 • Number of events 3 • Screening up to 21 days
All participants who received at least one dose of study drug.
|
6.7%
3/45 • Number of events 3 • Screening up to 21 days
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
13.3%
6/45 • Number of events 7 • Screening up to 21 days
All participants who received at least one dose of study drug.
|
2.2%
1/45 • Number of events 1 • Screening up to 21 days
All participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place