Trial Outcomes & Findings for A Study of Effects of Selpercatinib (LY3527723) on Midazolam in Healthy Participants (NCT NCT05338476)
NCT ID: NCT05338476
Last Updated: 2025-10-17
Results Overview
PK: PK: AUC0-t of midazolam and its metabolite 1-OH-midazolam was reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
Period 1: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose)
Results posted on
2025-10-17
Participant Flow
Participant milestones
| Measure |
Period 1: Midazolam
* Day 1: Participants received single oral dose of 2 milligram (mg) midazolam syrup.
|
Period 2: Selpercatinib + Midazolam
* Day 1 to Day 9: Participants received 160 mg Selpercatinib capsules twice daily (BID).
* Day 10: Participant received 160 mg Selpercatinib capsules BID co-administered with a single oral dose of 2 mg midazolam syrup on the morning of Day 10.
|
|---|---|---|
|
Period 1
STARTED
|
16
|
0
|
|
Period 1
Safety Analysis Population (Received at Least One Dose of Study Drug)
|
16
|
0
|
|
Period 1
COMPLETED
|
16
|
0
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
0
|
16
|
|
Period 2
Safety Analysis Population (Received at Least One Dose of Study Drug)
|
0
|
16
|
|
Period 2
COMPLETED
|
0
|
15
|
|
Period 2
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Period 1: Midazolam
* Day 1: Participants received single oral dose of 2 milligram (mg) midazolam syrup.
|
Period 2: Selpercatinib + Midazolam
* Day 1 to Day 9: Participants received 160 mg Selpercatinib capsules twice daily (BID).
* Day 10: Participant received 160 mg Selpercatinib capsules BID co-administered with a single oral dose of 2 mg midazolam syrup on the morning of Day 10.
|
|---|---|---|
|
Period 2
Adverse Event
|
0
|
1
|
Baseline Characteristics
A Study of Effects of Selpercatinib (LY3527723) on Midazolam in Healthy Participants
Baseline characteristics by cohort
| Measure |
All Participants
n=16 Participants
* Period 1: Participants received single oral dose of 2 milligram (mg) midazolam syrup on Day 1.
* Period 2: Participants received 160 mg Selpercatinib capsules twice daily (BID) from Day 1-10, and on Day 10 it was co-administered with a single oral dose of 2 mg midazolam syrup on the morning of Day 10.
|
|---|---|
|
Age, Continuous
|
41.1 years
STANDARD_DEVIATION 6.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 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
|
0 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 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
United States
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Period 1: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose)Population: All participants who complied sufficiently with the protocol and displayed an evaluable PK profile for this outcome.
PK: PK: AUC0-t of midazolam and its metabolite 1-OH-midazolam was reported.
Outcome measures
| Measure |
Period 1: Midazolam
n=16 Participants
* Day 1: Participants received single oral dose of 2 milligram (mg) midazolam syrup.
|
Period 2: Selpercatinib+ Midazolam
n=15 Participants
* Day 1 to Day 9: Participants received 160 mg Selpercatinib capsules twice daily (BID).
* Day 10: Participant received 160 mg Selpercatinib capsules BID co-administered with a single oral dose of 2 mg midazolam syrup on the morning of Day 10.
|
|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to the Last Observed Non-zero Concentration (AUC0-t) of Midazolam and Its Metabolite 1-hydroxymidazolam (1-OH-midazolam)
Midazolam
|
27.02 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 38.4
|
42.43 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 35.5
|
|
Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to the Last Observed Non-zero Concentration (AUC0-t) of Midazolam and Its Metabolite 1-hydroxymidazolam (1-OH-midazolam)
Metabolite: 1-OH-midazolam
|
41.02 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 100.7
|
55.81 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 80.5
|
PRIMARY outcome
Timeframe: Period 1: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose)Population: All participants who complied sufficiently with the protocol and displayed an evaluable PK profile for this outcome.
PK: PK: AUC0-inf of midazolam and its metabolite 1-OH-midazolam was reported.
Outcome measures
| Measure |
Period 1: Midazolam
n=16 Participants
* Day 1: Participants received single oral dose of 2 milligram (mg) midazolam syrup.
|
Period 2: Selpercatinib+ Midazolam
n=15 Participants
* Day 1 to Day 9: Participants received 160 mg Selpercatinib capsules twice daily (BID).
* Day 10: Participant received 160 mg Selpercatinib capsules BID co-administered with a single oral dose of 2 mg midazolam syrup on the morning of Day 10.
|
|---|---|---|
|
PK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Midazolam and Its Metabolite 1-OH-midazolam
Midazolam
|
28.46 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 38.4
|
45.00 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 36.7
|
|
PK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Midazolam and Its Metabolite 1-OH-midazolam
Metabolite: 1-OH-midazolam
|
43.29 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 100.3
|
59.49 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 80.2
|
PRIMARY outcome
Timeframe: Period 1: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose)Population: All participants who complied sufficiently with the protocol and displayed an evaluable PK profile for this outcome.
PK: PK: AUC%extrap of midazolam and its metabolite 1-OH-midazolam was reported.
Outcome measures
| Measure |
Period 1: Midazolam
n=16 Participants
* Day 1: Participants received single oral dose of 2 milligram (mg) midazolam syrup.
|
Period 2: Selpercatinib+ Midazolam
n=15 Participants
* Day 1 to Day 9: Participants received 160 mg Selpercatinib capsules twice daily (BID).
* Day 10: Participant received 160 mg Selpercatinib capsules BID co-administered with a single oral dose of 2 mg midazolam syrup on the morning of Day 10.
|
|---|---|---|
|
PK: Percent of AUC0-inf Extrapolated (AUC%Extrap) of Midazolam and Its Metabolite 1-OH-midazolam
Midazolam
|
4.763 percent AUC extrapolation
Geometric Coefficient of Variation 36.9
|
5.165 percent AUC extrapolation
Geometric Coefficient of Variation 48.1
|
|
PK: Percent of AUC0-inf Extrapolated (AUC%Extrap) of Midazolam and Its Metabolite 1-OH-midazolam
Metabolite: 1-OH-midazolam
|
4.869 percent AUC extrapolation
Geometric Coefficient of Variation 41.3
|
5.849 percent AUC extrapolation
Geometric Coefficient of Variation 36.3
|
PRIMARY outcome
Timeframe: Period 1: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose)Population: All participants who complied sufficiently with the protocol and displayed an evaluable PK profile for this outcome
PK: Cmax of midazolam and its metabolite 1-OH-midazolam was reported.
Outcome measures
| Measure |
Period 1: Midazolam
n=16 Participants
* Day 1: Participants received single oral dose of 2 milligram (mg) midazolam syrup.
|
Period 2: Selpercatinib+ Midazolam
n=15 Participants
* Day 1 to Day 9: Participants received 160 mg Selpercatinib capsules twice daily (BID).
* Day 10: Participant received 160 mg Selpercatinib capsules BID co-administered with a single oral dose of 2 mg midazolam syrup on the morning of Day 10.
|
|---|---|---|
|
PK: Maximum Observed Concentration (Cmax) of Midazolam and Its Metabolite 1-OH-midazolam
Midazolam
|
11.94 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 32.0
|
16.76 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 39.9
|
|
PK: Maximum Observed Concentration (Cmax) of Midazolam and Its Metabolite 1-OH-midazolam
Metabolite: 1-OH-midazolam
|
15.98 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 70.1
|
17.91 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 70.3
|
PRIMARY outcome
Timeframe: Period 1: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose)Population: All participants who complied sufficiently with the protocol and displayed an evaluable PK profile for this outcome.
PK: Tmax of midazolam and its metabolite 1-OH-midazolam was reported.
Outcome measures
| Measure |
Period 1: Midazolam
n=16 Participants
* Day 1: Participants received single oral dose of 2 milligram (mg) midazolam syrup.
|
Period 2: Selpercatinib+ Midazolam
n=15 Participants
* Day 1 to Day 9: Participants received 160 mg Selpercatinib capsules twice daily (BID).
* Day 10: Participant received 160 mg Selpercatinib capsules BID co-administered with a single oral dose of 2 mg midazolam syrup on the morning of Day 10.
|
|---|---|---|
|
PK: Time to Reach Maximum Observed Concentration (Tmax) of Midazolam and Its Metabolite 1-OH-midazolam
Midazolam
|
0.584 hours
Geometric Coefficient of Variation 20.4
|
0.626 hours
Geometric Coefficient of Variation 33.6
|
|
PK: Time to Reach Maximum Observed Concentration (Tmax) of Midazolam and Its Metabolite 1-OH-midazolam
Metabolite: 1-OH-midazolam
|
0.668 hours
Geometric Coefficient of Variation 25.3
|
0.738 hours
Geometric Coefficient of Variation 30.6
|
PRIMARY outcome
Timeframe: Period 1: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose)Population: All participants who complied sufficiently with the protocol and displayed an evaluable PK profile for this outcome.
PK: Kel of midazolam and its metabolite 1-OH-midazolam was reported.
Outcome measures
| Measure |
Period 1: Midazolam
n=16 Participants
* Day 1: Participants received single oral dose of 2 milligram (mg) midazolam syrup.
|
Period 2: Selpercatinib+ Midazolam
n=15 Participants
* Day 1 to Day 9: Participants received 160 mg Selpercatinib capsules twice daily (BID).
* Day 10: Participant received 160 mg Selpercatinib capsules BID co-administered with a single oral dose of 2 mg midazolam syrup on the morning of Day 10.
|
|---|---|---|
|
PK: Apparent Terminal Elimination Rate Constant (Kel) of Midazolam and Its Metabolite 1-OH-midazolam
Midazolam
|
0.1193 One per hour (1/h)
Geometric Coefficient of Variation 32.5
|
0.09787 One per hour (1/h)
Geometric Coefficient of Variation 22.1
|
|
PK: Apparent Terminal Elimination Rate Constant (Kel) of Midazolam and Its Metabolite 1-OH-midazolam
Metabolite: 1-OH-midazolam
|
0.1105 One per hour (1/h)
Geometric Coefficient of Variation 31.4
|
0.09474 One per hour (1/h)
Geometric Coefficient of Variation 18.2
|
PRIMARY outcome
Timeframe: Period 1: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose)Population: All participants who complied sufficiently with the protocol and displayed an evaluable PK profile for this outcome.
PK: t½ of midazolam and its metabolite 1-OH-midazolam was reported.
Outcome measures
| Measure |
Period 1: Midazolam
n=16 Participants
* Day 1: Participants received single oral dose of 2 milligram (mg) midazolam syrup.
|
Period 2: Selpercatinib+ Midazolam
n=15 Participants
* Day 1 to Day 9: Participants received 160 mg Selpercatinib capsules twice daily (BID).
* Day 10: Participant received 160 mg Selpercatinib capsules BID co-administered with a single oral dose of 2 mg midazolam syrup on the morning of Day 10.
|
|---|---|---|
|
PK: Apparent Terminal Elimination Half-life (t½) of Midazolam and Its Metabolite 1-OH-midazolam
Midazolam
|
5.812 hours
Geometric Coefficient of Variation 32.5
|
7.082 hours
Geometric Coefficient of Variation 22.1
|
|
PK: Apparent Terminal Elimination Half-life (t½) of Midazolam and Its Metabolite 1-OH-midazolam
Metabolite: 1-OH-midazolam
|
6.275 hours
Geometric Coefficient of Variation 31.4
|
7.317 hours
Geometric Coefficient of Variation 18.2
|
PRIMARY outcome
Timeframe: Period 1: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose)Population: All participants who complied sufficiently with the protocol and displayed an evaluable PK profile for this outcome.
PK: CL/F of midazolam was reported.
Outcome measures
| Measure |
Period 1: Midazolam
n=16 Participants
* Day 1: Participants received single oral dose of 2 milligram (mg) midazolam syrup.
|
Period 2: Selpercatinib+ Midazolam
n=15 Participants
* Day 1 to Day 9: Participants received 160 mg Selpercatinib capsules twice daily (BID).
* Day 10: Participant received 160 mg Selpercatinib capsules BID co-administered with a single oral dose of 2 mg midazolam syrup on the morning of Day 10.
|
|---|---|---|
|
PK: Apparent Total Plasma Clearance After Oral (Extravascular) Administration (CL/F) of Midazolam
|
70.26 Liter per Hour (L/h)
Geometric Coefficient of Variation 38.4
|
44.44 Liter per Hour (L/h)
Geometric Coefficient of Variation 36.7
|
PRIMARY outcome
Timeframe: Period 1: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose)Population: All participants who complied sufficiently with the protocol and displayed an evaluable PK profile for this outcome.
PK: Vz/F of midazolam was reported.
Outcome measures
| Measure |
Period 1: Midazolam
n=16 Participants
* Day 1: Participants received single oral dose of 2 milligram (mg) midazolam syrup.
|
Period 2: Selpercatinib+ Midazolam
n=15 Participants
* Day 1 to Day 9: Participants received 160 mg Selpercatinib capsules twice daily (BID).
* Day 10: Participant received 160 mg Selpercatinib capsules BID co-administered with a single oral dose of 2 mg midazolam syrup on the morning of Day 10.
|
|---|---|---|
|
PK: Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of Midazolam
|
589.1 Liter (L)
Geometric Coefficient of Variation 35.0
|
454.1 Liter (L)
Geometric Coefficient of Variation 32.3
|
SECONDARY outcome
Timeframe: Period 2: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post dose)Population: All participants who complied sufficiently with the protocol and displayed an evaluable PK profile.
PK: AUC0-12 of Selpercatinib was reported.
Outcome measures
| Measure |
Period 1: Midazolam
n=16 Participants
* Day 1: Participants received single oral dose of 2 milligram (mg) midazolam syrup.
|
Period 2: Selpercatinib+ Midazolam
* Day 1 to Day 9: Participants received 160 mg Selpercatinib capsules twice daily (BID).
* Day 10: Participant received 160 mg Selpercatinib capsules BID co-administered with a single oral dose of 2 mg midazolam syrup on the morning of Day 10.
|
|---|---|---|
|
PK: Area Under the Concentration-time Curve, From Time 0 to the 12 Hour (AUC0-12) of Selpercatinib
|
10710 ng*h/mL
Geometric Coefficient of Variation 36.9
|
—
|
SECONDARY outcome
Timeframe: Period 2: Day 9 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post dose); Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose)Population: All participants who complied sufficiently with the protocol and displayed an evaluable PK profile for this outcome.
PK: AUC0-tau of Selpercatinib was reported.
Outcome measures
| Measure |
Period 1: Midazolam
n=15 Participants
* Day 1: Participants received single oral dose of 2 milligram (mg) midazolam syrup.
|
Period 2: Selpercatinib+ Midazolam
* Day 1 to Day 9: Participants received 160 mg Selpercatinib capsules twice daily (BID).
* Day 10: Participant received 160 mg Selpercatinib capsules BID co-administered with a single oral dose of 2 mg midazolam syrup on the morning of Day 10.
|
|---|---|---|
|
PK: Area Under the Concentration-time Curve During a Dosing Interval (Tau) at Steady State (AUCtau) of Selpercatinib
Day 9
|
37610 ng*h/mL
Geometric Coefficient of Variation 32.4
|
—
|
|
PK: Area Under the Concentration-time Curve During a Dosing Interval (Tau) at Steady State (AUCtau) of Selpercatinib
Day 10
|
36890 ng*h/mL
Geometric Coefficient of Variation 33.5
|
—
|
SECONDARY outcome
Timeframe: Period 2: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post dose)Population: All participants who complied sufficiently with the protocol and displayed an evaluable PK profile.
PK: Cmax of Selpercatinib was reported.
Outcome measures
| Measure |
Period 1: Midazolam
n=16 Participants
* Day 1: Participants received single oral dose of 2 milligram (mg) midazolam syrup.
|
Period 2: Selpercatinib+ Midazolam
* Day 1 to Day 9: Participants received 160 mg Selpercatinib capsules twice daily (BID).
* Day 10: Participant received 160 mg Selpercatinib capsules BID co-administered with a single oral dose of 2 mg midazolam syrup on the morning of Day 10.
|
|---|---|---|
|
PK: Maximum Observed Concentration (Cmax) of Selpercatinib
|
1859 ng/mL
Geometric Coefficient of Variation 50.3
|
—
|
SECONDARY outcome
Timeframe: Period 2: Day 9 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post dose); Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose)Population: All participants who complied sufficiently with the protocol and displayed an evaluable PK profile for this outcome.
PK: Cmax,ss of Selpercatinib was reported.
Outcome measures
| Measure |
Period 1: Midazolam
n=15 Participants
* Day 1: Participants received single oral dose of 2 milligram (mg) midazolam syrup.
|
Period 2: Selpercatinib+ Midazolam
* Day 1 to Day 9: Participants received 160 mg Selpercatinib capsules twice daily (BID).
* Day 10: Participant received 160 mg Selpercatinib capsules BID co-administered with a single oral dose of 2 mg midazolam syrup on the morning of Day 10.
|
|---|---|---|
|
PK: Maximum Observed Concentration at Steady-state (Cmax,ss) of Selpercatinib
Day 9
|
4574 ng/mL
Geometric Coefficient of Variation 38.0
|
—
|
|
PK: Maximum Observed Concentration at Steady-state (Cmax,ss) of Selpercatinib
Day 10
|
4190 ng/mL
Geometric Coefficient of Variation 36.8
|
—
|
SECONDARY outcome
Timeframe: Period 2: Predose at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9Population: All participants who complied sufficiently with the protocol and displayed an evaluable PK profile for this outcome. 'Number analyzed' signifies participants with available data at specified timepoints.
PK: Ctrough of Selpercatinib was reported.
Outcome measures
| Measure |
Period 1: Midazolam
n=16 Participants
* Day 1: Participants received single oral dose of 2 milligram (mg) midazolam syrup.
|
Period 2: Selpercatinib+ Midazolam
* Day 1 to Day 9: Participants received 160 mg Selpercatinib capsules twice daily (BID).
* Day 10: Participant received 160 mg Selpercatinib capsules BID co-administered with a single oral dose of 2 mg midazolam syrup on the morning of Day 10.
|
|---|---|---|
|
PK: Concentration Observed at the End of the Dosing Interval (Ctrough) of Selpercatinib
Day 1
|
1301 ng/mL
Geometric Coefficient of Variation 23.1
|
—
|
|
PK: Concentration Observed at the End of the Dosing Interval (Ctrough) of Selpercatinib
Day 2
|
1843 ng/mL
Geometric Coefficient of Variation 27.6
|
—
|
|
PK: Concentration Observed at the End of the Dosing Interval (Ctrough) of Selpercatinib
Day 3
|
2022 ng/mL
Geometric Coefficient of Variation 29.4
|
—
|
|
PK: Concentration Observed at the End of the Dosing Interval (Ctrough) of Selpercatinib
Day 4
|
2213 ng/mL
Geometric Coefficient of Variation 35.5
|
—
|
|
PK: Concentration Observed at the End of the Dosing Interval (Ctrough) of Selpercatinib
Day 5
|
2373 ng/mL
Geometric Coefficient of Variation 34.9
|
—
|
|
PK: Concentration Observed at the End of the Dosing Interval (Ctrough) of Selpercatinib
Day 6
|
2660 ng/mL
Geometric Coefficient of Variation 37.6
|
—
|
|
PK: Concentration Observed at the End of the Dosing Interval (Ctrough) of Selpercatinib
Day 7
|
2606 ng/mL
Geometric Coefficient of Variation 32.7
|
—
|
|
PK: Concentration Observed at the End of the Dosing Interval (Ctrough) of Selpercatinib
Day 8
|
2733 ng/mL
Geometric Coefficient of Variation 26.0
|
—
|
|
PK: Concentration Observed at the End of the Dosing Interval (Ctrough) of Selpercatinib
Day 9
|
2754 ng/mL
Geometric Coefficient of Variation 30.9
|
—
|
SECONDARY outcome
Timeframe: Period 2: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post dose)Population: All participants who complied sufficiently with the protocol and displayed an evaluable PK profile.
PK: tmax of Selpercatinib was reported.
Outcome measures
| Measure |
Period 1: Midazolam
n=16 Participants
* Day 1: Participants received single oral dose of 2 milligram (mg) midazolam syrup.
|
Period 2: Selpercatinib+ Midazolam
* Day 1 to Day 9: Participants received 160 mg Selpercatinib capsules twice daily (BID).
* Day 10: Participant received 160 mg Selpercatinib capsules BID co-administered with a single oral dose of 2 mg midazolam syrup on the morning of Day 10.
|
|---|---|---|
|
PK: Time to Reach Maximum Observed Concentration (Tmax) of Selpercatinib
|
1.843 hours
Geometric Coefficient of Variation 45.9
|
—
|
SECONDARY outcome
Timeframe: Period 2: Day 9 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post dose); Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose)Population: All participants who complied sufficiently with the protocol and displayed an evaluable PK profile for this outcome.
PK: Tmax,ss of Selpercatinib was reported.
Outcome measures
| Measure |
Period 1: Midazolam
n=15 Participants
* Day 1: Participants received single oral dose of 2 milligram (mg) midazolam syrup.
|
Period 2: Selpercatinib+ Midazolam
* Day 1 to Day 9: Participants received 160 mg Selpercatinib capsules twice daily (BID).
* Day 10: Participant received 160 mg Selpercatinib capsules BID co-administered with a single oral dose of 2 mg midazolam syrup on the morning of Day 10.
|
|---|---|---|
|
PK: Time to Reach Maximum Observed Concentration at Steady-state (Tmax,ss) of Selpercatinib
Day 9
|
1.955 hours
Geometric Coefficient of Variation 76.0
|
—
|
|
PK: Time to Reach Maximum Observed Concentration at Steady-state (Tmax,ss) of Selpercatinib
Day 10
|
1.752 hours
Geometric Coefficient of Variation 55.8
|
—
|
SECONDARY outcome
Timeframe: Period 2: Day 9 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post dose); Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose)Population: All participants who complied sufficiently with the protocol and displayed an evaluable PK profile for this outcome. 'Number analyzed' signifies participants with available data at specified timepoints.
PK: CL,ss/F of Selpercatinib was reported.
Outcome measures
| Measure |
Period 1: Midazolam
n=11 Participants
* Day 1: Participants received single oral dose of 2 milligram (mg) midazolam syrup.
|
Period 2: Selpercatinib+ Midazolam
* Day 1 to Day 9: Participants received 160 mg Selpercatinib capsules twice daily (BID).
* Day 10: Participant received 160 mg Selpercatinib capsules BID co-administered with a single oral dose of 2 mg midazolam syrup on the morning of Day 10.
|
|---|---|---|
|
PK: Apparent Total Plasma Clearance at Steady State After Oral/Extravascular Administration (CL,ss/F) of Selpercatinib
Day 9
|
1.930 Liter per Hours (L/h)
Geometric Coefficient of Variation 35.8
|
—
|
|
PK: Apparent Total Plasma Clearance at Steady State After Oral/Extravascular Administration (CL,ss/F) of Selpercatinib
Day 10
|
2.027 Liter per Hours (L/h)
Geometric Coefficient of Variation 34.5
|
—
|
Adverse Events
Period 1: Midazolam (Day 1)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Period 2: Selpercatinib (Day 1 to Day 9)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Period 2: Selpercatinib + Midazolam (Day 10)
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 |
Period 1: Midazolam (Day 1)
n=16 participants at risk
* Day 1: Participants received single oral dose of 2 milligram (mg) midazolam syrup.
|
Period 2: Selpercatinib (Day 1 to Day 9)
n=16 participants at risk
* Day 1 to Day 9: Participants received 160 mg Selpercatinib capsules twice daily (BID).
|
Period 2: Selpercatinib + Midazolam (Day 10)
n=15 participants at risk
* Day 10: Participant received 160 mg Selpercatinib capsules BID co-administered with a single oral dose of 2 mg midazolam syrup on the morning of Day 10.
|
|---|---|---|---|
|
Ear and labyrinth disorders
Hyperacusis
|
0.00%
0/16 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
6.2%
1/16 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
0.00%
0/15 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/16 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
12.5%
2/16 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
0.00%
0/15 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
4/16 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
18.8%
3/16 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
0.00%
0/15 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/16 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
6.2%
1/16 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
0.00%
0/15 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
|
Infections and infestations
Asymptomatic bacteriuria
|
0.00%
0/16 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
0.00%
0/16 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
6.7%
1/15 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/16 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
6.2%
1/16 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
0.00%
0/15 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/16 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
6.2%
1/16 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
6.7%
1/15 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/16 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
6.2%
1/16 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
0.00%
0/15 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
|
Investigations
Platelet count decreased
|
0.00%
0/16 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
0.00%
0/16 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
6.7%
1/15 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/16 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
12.5%
2/16 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
0.00%
0/15 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/16 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
6.2%
1/16 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
0.00%
0/15 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/16 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
6.2%
1/16 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
0.00%
0/15 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/16 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
18.8%
3/16 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
6.7%
1/15 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/16 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
6.2%
1/16 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
0.00%
0/15 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/16 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
12.5%
2/16 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
0.00%
0/15 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
|
Nervous system disorders
Headache
|
0.00%
0/16 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
50.0%
8/16 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
0.00%
0/15 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/16 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
6.2%
1/16 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
0.00%
0/15 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/16 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
6.2%
1/16 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
0.00%
0/15 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/16 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
6.2%
1/16 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
6.7%
1/15 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
|
Vascular disorders
Hypertension
|
6.2%
1/16 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
6.2%
1/16 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
0.00%
0/15 • Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: All participants who received at least one dose of study drug. * 1 participant discontinued the study after receiving the Selpercatinib dose on Day 5 in Period 2. Therefore, safety analysis population for the Period 2: Selpercatinib + Midazolam (Day 10) treatment includes only the remaining 15 participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60