Trial Outcomes & Findings for A Study of Effect of Selpercatinib (LY3527723) on Corrected QT (QTc) Interval in Healthy Participants (NCT NCT05630274)
NCT ID: NCT05630274
Last Updated: 2025-09-18
Results Overview
The cardiodynamic assessment was performed through 12-lead electrocardiogram (ECG) extracted from continuous recordings at pre-specified time points. Participants rested in supine position for at least 10 minutes prior to and 5 minutes after each time point for ECG extractions. The QT interval is the time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole. QT interval was corrected for heart rate using QTcF. Placebo-corrected change from baseline in QTcF (ΔΔQTcF) was calculated based on model-predicted effect
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Pre-dose, -0.25, -0.5, -0.25, 0.25, 0.5, 0.75, 1.5, 2, 2.5, 3, 4, 7, 9, 12, and 24 hours post-dose
Results posted on
2025-09-18
Participant Flow
Participants were randomized to 4 treatment sequences (ABCD, BDAC, CADB, and DCBA), with each sequence having 4 periods where participants were crossed over between the periods. There was a washout period of 10 days between dosing in each period.
Participant milestones
| Measure |
Treatment Sequence 1: ABCD
Period 1: 320 milligram (mg) Selpercatinib and Selpercatinib matching placebo (Treatment A)
Period 2: 640 mg Selpercatinib (Treatment B)
Period 3: 400 mg moxifloxacin (Treatment C)
Period 4: Selpercatinib matching placebo (Treatment D)
Participants received their assigned treatments in each of the above treatment period on Day 1 orally.
|
Treatment Sequence 2: BDAC
Period 1: 640 mg Selpercatinib (Treatment B)
Period 2: Selpercatinib matching placebo (Treatment D)
Period 3: 320 mg Selpercatinib and Selpercatinib matching placebo (Treatment A)
Period 4: 400 mg moxifloxacin (Treatment C)
Participants received their assigned treatments in each of the above treatment period on Day 1 orally.
|
Treatment Sequence 3: CADB
Period 1: 400 mg moxifloxacin (Treatment C)
Period 2: Selpercatinib matching placebo (Treatment D)
Period 3: 320 mg Selpercatinib and Selpercatinib matching placebo (Treatment A)
Period 4: 640 mg Selpercatinib (Treatment B)
Participants received their assigned treatments in each of the above treatment period on Day 1 orally.
|
Treatment Sequence 4: DCBA
Period 1: Selpercatinib matching placebo (Treatment D)
Period 2: 400 mg moxifloxacin (Treatment C)
Period 3: 640 mg Selpercatinib (Treatment B)
Period 4: 320 mg Selpercatinib and Selpercatinib matching placebo (Treatment A)
Participants received their assigned treatments in each of the above treatment period on Day 1 orally.
|
|---|---|---|---|---|
|
Treatment Period 1
STARTED
|
8
|
8
|
8
|
8
|
|
Treatment Period 1
Received at Least One Dose of Study Drug
|
8
|
8
|
8
|
8
|
|
Treatment Period 1
COMPLETED
|
8
|
8
|
8
|
8
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Treatment Period 2
STARTED
|
8
|
8
|
8
|
8
|
|
Treatment Period 2
Received at Least One Dose of Study Drug
|
8
|
8
|
8
|
8
|
|
Treatment Period 2
COMPLETED
|
8
|
8
|
8
|
8
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Treatment Period 3
STARTED
|
8
|
8
|
8
|
8
|
|
Treatment Period 3
Received at Least One Dose of Study Drug
|
8
|
8
|
8
|
8
|
|
Treatment Period 3
COMPLETED
|
8
|
8
|
8
|
8
|
|
Treatment Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Treatment Period 4
STARTED
|
8
|
8
|
8
|
8
|
|
Treatment Period 4
Received at Least One Dose of Study Drug
|
8
|
8
|
8
|
8
|
|
Treatment Period 4
COMPLETED
|
8
|
8
|
8
|
8
|
|
Treatment Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Effect of Selpercatinib (LY3527723) on Corrected QT (QTc) Interval in Healthy Participants
Baseline characteristics by cohort
| Measure |
Treatment Sequence 1: ABCD
n=8 Participants
Period 1: 320 mg Selpercatinib and Selpercatinib matching placebo (Treatment A)
Period 2: 640 mg Selpercatinib (Treatment B)
Period 3: 400 mg moxifloxacin (Treatment C)
Period 4: Selpercatinib matching placebo (Treatment D)
Participants received their assigned treatments in each of the above treatment period on Day 1 orally.
|
Treatment Sequence 2: BDAC
n=8 Participants
Period 1: 640 mg Selpercatinib (Treatment B)
Period 2: Selpercatinib matching placebo (Treatment D)
Period 3: 320 mg Selpercatinib and Selpercatinib matching placebo (Treatment A)
Period 4: 400 mg moxifloxacin (Treatment C)
Participants received their assigned treatments in each of the above treatment period on Day 1 orally.
|
Treatment Sequence 3: CADB
n=8 Participants
Period 1: 400 mg moxifloxacin (Treatment C)
Period 2: Selpercatinib matching placebo (Treatment D)
Period 3: 320 mg Selpercatinib and Selpercatinib matching placebo (Treatment A)
Period 4: 640 mg Selpercatinib (Treatment B)
Participants received their assigned treatments in each of the above treatment period on Day 1 orally.
|
Treatment Sequence 4: DCBA
n=8 Participants
Period 1: Selpercatinib matching placebo (Treatment D)
Period 2: 400 mg moxifloxacin (Treatment C)
Period 3: 640 mg Selpercatinib (Treatment B)
Period 4: 320 mg Selpercatinib and Selpercatinib matching placebo (Treatment A)
Participants received their assigned treatments in each of the above treatment period on Day 1 orally.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
35.0 years
STANDARD_DEVIATION 11.44 • n=99 Participants
|
40.3 years
STANDARD_DEVIATION 8.78 • n=107 Participants
|
44.0 years
STANDARD_DEVIATION 8.88 • n=206 Participants
|
10.18 years
STANDARD_DEVIATION 10.18 • n=7 Participants
|
40.5 years
STANDARD_DEVIATION 10.02 • n=31 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
26 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
18 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
25 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
32 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, -0.25, -0.5, -0.25, 0.25, 0.5, 0.75, 1.5, 2, 2.5, 3, 4, 7, 9, 12, and 24 hours post-dosePopulation: All randomized participants who received at least one dose of selpercatinib or moxifloxacin with measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTc value.
The cardiodynamic assessment was performed through 12-lead electrocardiogram (ECG) extracted from continuous recordings at pre-specified time points. Participants rested in supine position for at least 10 minutes prior to and 5 minutes after each time point for ECG extractions. The QT interval is the time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole. QT interval was corrected for heart rate using QTcF. Placebo-corrected change from baseline in QTcF (ΔΔQTcF) was calculated based on model-predicted effect
Outcome measures
| Measure |
320 mg Selpercatinib (Treatment A)
n=8 Participants
Participants received single oral dose of 320 mg selpercatinib.
|
640 mg Selpercatnib (Treatment B)
n=8 Participants
Participants received single oral dose of 640 mg selpercatinib.
|
400 mg Moxifloxacin (Treatment C)
n=8 Participants
Participants received single oral dose of 400 mg moxifloxacin.
|
|---|---|---|---|
|
Cardiodynamics: Placebo-corrected Change From Baseline in QT Interval Corrected Using Fridericia's Correction (QTcF) (ΔΔQTcF) for Treatments A, B, and C
|
3.4 milliseconds
Interval 0.4 to 6.34
|
4.4 milliseconds
Interval 1.37 to 7.4
|
6.4 milliseconds
Interval 3.38 to 9.43
|
PRIMARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdosePopulation: All randomized participants who received at least one dose of selpercatinib and had evaluable PK data.
PK: AUC0-t of Selpercatinib is reported.
Outcome measures
| Measure |
320 mg Selpercatinib (Treatment A)
n=32 Participants
Participants received single oral dose of 320 mg selpercatinib.
|
640 mg Selpercatnib (Treatment B)
n=31 Participants
Participants received single oral dose of 640 mg selpercatinib.
|
400 mg Moxifloxacin (Treatment C)
Participants received single oral dose of 400 mg moxifloxacin.
|
|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration-time Curve From Time 0 to the Time of the Last Observed Non-zero Concentration (AUC0-t) of Selpercatinib
|
33730 nanogram*hour per millilitre (ng*h/mL)
Geometric Coefficient of Variation 42.3
|
42670 nanogram*hour per millilitre (ng*h/mL)
Geometric Coefficient of Variation 65.8
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdosePopulation: All randomized participants who received at least one dose of selpercatinib and had evaluable PK data.
PK: AUC0-inf of Selpercatinib is reported.
Outcome measures
| Measure |
320 mg Selpercatinib (Treatment A)
n=32 Participants
Participants received single oral dose of 320 mg selpercatinib.
|
640 mg Selpercatnib (Treatment B)
n=31 Participants
Participants received single oral dose of 640 mg selpercatinib.
|
400 mg Moxifloxacin (Treatment C)
Participants received single oral dose of 400 mg moxifloxacin.
|
|---|---|---|---|
|
PK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Selpercatinib
|
33830 ng*hr/mL
Geometric Coefficient of Variation 42.3
|
42830 ng*hr/mL
Geometric Coefficient of Variation 65.7
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdosePopulation: All randomized participants who received at least one dose of selpercatinib and had evaluable PK data.
PK: AUC%extrap of Selpercatinib is reported.
Outcome measures
| Measure |
320 mg Selpercatinib (Treatment A)
n=32 Participants
Participants received single oral dose of 320 mg selpercatinib.
|
640 mg Selpercatnib (Treatment B)
n=31 Participants
Participants received single oral dose of 640 mg selpercatinib.
|
400 mg Moxifloxacin (Treatment C)
Participants received single oral dose of 400 mg moxifloxacin.
|
|---|---|---|---|
|
PK: Percent of AUC0-inf Extrapolated (AUC%Extrap) of Selpercatinib
|
0.2986 percentage of AUC0-inf extrapolated
Standard Deviation 0.21464
|
0.3734 percentage of AUC0-inf extrapolated
Standard Deviation 0.53500
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdosePopulation: All randomized participants who received at least one dose of selpercatinib and had evaluable PK data.
PK: Cmax of Selpercatinib is reported.
Outcome measures
| Measure |
320 mg Selpercatinib (Treatment A)
n=32 Participants
Participants received single oral dose of 320 mg selpercatinib.
|
640 mg Selpercatnib (Treatment B)
n=31 Participants
Participants received single oral dose of 640 mg selpercatinib.
|
400 mg Moxifloxacin (Treatment C)
Participants received single oral dose of 400 mg moxifloxacin.
|
|---|---|---|---|
|
PK: Maximum Observed Concentration (Cmax) of Selpercatinib
|
2024 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 74.6
|
2356 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 103.0
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdosePopulation: All randomized participants who received at least one dose of selpercatinib and had evaluable PK data.
PK: Tmax of Selpercatinib is reported.
Outcome measures
| Measure |
320 mg Selpercatinib (Treatment A)
n=32 Participants
Participants received single oral dose of 320 mg selpercatinib.
|
640 mg Selpercatnib (Treatment B)
n=31 Participants
Participants received single oral dose of 640 mg selpercatinib.
|
400 mg Moxifloxacin (Treatment C)
Participants received single oral dose of 400 mg moxifloxacin.
|
|---|---|---|---|
|
PK: Time to Reach Cmax (Tmax) of Selpercatinib
|
1.557 hour
Interval 0.8 to 24.06
|
2.051 hour
Interval 0.82 to 4.09
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdosePopulation: All randomized participants who received at least one dose of selpercatinib and had evaluable PK data.
PK: Kel of Selpercatinib is reported.
Outcome measures
| Measure |
320 mg Selpercatinib (Treatment A)
n=32 Participants
Participants received single oral dose of 320 mg selpercatinib.
|
640 mg Selpercatnib (Treatment B)
n=31 Participants
Participants received single oral dose of 640 mg selpercatinib.
|
400 mg Moxifloxacin (Treatment C)
Participants received single oral dose of 400 mg moxifloxacin.
|
|---|---|---|---|
|
PK: Apparent First Order Terminal Elimination Rate Constant (Kel) of Selpercatinib
|
0.02515 1/hour
Standard Deviation 0.0087987
|
0.02459 1/hour
Standard Deviation 0.0070524
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdosePopulation: All randomized participants who received at least one dose of selpercatinib and had evaluable PK data.
PK: t½ of Selpercatinib is reported.
Outcome measures
| Measure |
320 mg Selpercatinib (Treatment A)
n=32 Participants
Participants received single oral dose of 320 mg selpercatinib.
|
640 mg Selpercatnib (Treatment B)
n=31 Participants
Participants received single oral dose of 640 mg selpercatinib.
|
400 mg Moxifloxacin (Treatment C)
Participants received single oral dose of 400 mg moxifloxacin.
|
|---|---|---|---|
|
PK: Apparent First-order Terminal Elimination Half-life (t½) of Selpercatinib
|
31.189 hour
Standard Deviation 11.6988
|
30.582 hour
Standard Deviation 9.2791
|
—
|
Adverse Events
320 mg Selpercatinib
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
640 mg Selpercatinib
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
400 mg Moxifloxacin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Selpercatinib Matching Placebo
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 |
320 mg Selpercatinib
n=32 participants at risk
Participants received 320 mg Selpercatinib and administered orally on day 1.
|
640 mg Selpercatinib
n=32 participants at risk
Participants received 640 mg Selpercatinib administered orally on day 1.
|
400 mg Moxifloxacin
n=32 participants at risk
Participants received 400 mg moxifloxacin administered orally on day 1.
|
Selpercatinib Matching Placebo
n=32 participants at risk
Participants received Selpercatinib matching placebo administered orally on day 1.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
6.2%
2/32 • Number of events 2 • Baseline up to 41 Days
All participants who received at least one dose of the study drug. Per analysis plan adverse events were analyzed per each dose level.
|
0.00%
0/32 • Baseline up to 41 Days
All participants who received at least one dose of the study drug. Per analysis plan adverse events were analyzed per each dose level.
|
0.00%
0/32 • Baseline up to 41 Days
All participants who received at least one dose of the study drug. Per analysis plan adverse events were analyzed per each dose level.
|
12.5%
4/32 • Number of events 4 • Baseline up to 41 Days
All participants who received at least one dose of the study drug. Per analysis plan adverse events were analyzed per each dose level.
|
|
Gastrointestinal disorders
Nausea
|
6.2%
2/32 • Number of events 2 • Baseline up to 41 Days
All participants who received at least one dose of the study drug. Per analysis plan adverse events were analyzed per each dose level.
|
0.00%
0/32 • Baseline up to 41 Days
All participants who received at least one dose of the study drug. Per analysis plan adverse events were analyzed per each dose level.
|
0.00%
0/32 • Baseline up to 41 Days
All participants who received at least one dose of the study drug. Per analysis plan adverse events were analyzed per each dose level.
|
0.00%
0/32 • Baseline up to 41 Days
All participants who received at least one dose of the study drug. Per analysis plan adverse events were analyzed per each dose level.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/32 • Baseline up to 41 Days
All participants who received at least one dose of the study drug. Per analysis plan adverse events were analyzed per each dose level.
|
6.2%
2/32 • Number of events 2 • Baseline up to 41 Days
All participants who received at least one dose of the study drug. Per analysis plan adverse events were analyzed per each dose level.
|
0.00%
0/32 • Baseline up to 41 Days
All participants who received at least one dose of the study drug. Per analysis plan adverse events were analyzed per each dose level.
|
0.00%
0/32 • Baseline up to 41 Days
All participants who received at least one dose of the study drug. Per analysis plan adverse events were analyzed per each dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.2%
2/32 • Number of events 2 • Baseline up to 41 Days
All participants who received at least one dose of the study drug. Per analysis plan adverse events were analyzed per each dose level.
|
0.00%
0/32 • Baseline up to 41 Days
All participants who received at least one dose of the study drug. Per analysis plan adverse events were analyzed per each dose level.
|
0.00%
0/32 • Baseline up to 41 Days
All participants who received at least one dose of the study drug. Per analysis plan adverse events were analyzed per each dose level.
|
0.00%
0/32 • Baseline up to 41 Days
All participants who received at least one dose of the study drug. Per analysis plan adverse events were analyzed per each dose level.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60