Trial Outcomes & Findings for A Drug Drug Interaction (DDI) Study of Selpercatinib and Dabigatran in Healthy Participants (NCT NCT04782076)
NCT ID: NCT04782076
Last Updated: 2024-05-24
Results Overview
PK: Cmax of Dabigatran
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
Day 1 and Day 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours (h) postdose
Results posted on
2024-05-24
Participant Flow
Participant milestones
| Measure |
Dabigatran + Selpercatinib
Participants received a single oral dose of 150 milligrams (mg) dabigatran on Day 1 and a single oral dose of 150 mg dabigatran coadministered with a single oral dose of 2 x 80 mg (160 mg) Selpercatinib on Day 8.
There was a washout period of 7 days between dosing on Days 1 and 8.
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
Received at Least One Dose of Dabigatran on Day 1
|
36
|
|
Overall Study
Washout Period
|
36
|
|
Overall Study
Received at Least One Dose of Selpercatinib and Dabigatran on Day 8
|
35
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Dabigatran + Selpercatinib
Participants received a single oral dose of 150 milligrams (mg) dabigatran on Day 1 and a single oral dose of 150 mg dabigatran coadministered with a single oral dose of 2 x 80 mg (160 mg) Selpercatinib on Day 8.
There was a washout period of 7 days between dosing on Days 1 and 8.
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|---|---|
|
Overall Study
Family Emergency
|
1
|
Baseline Characteristics
A Drug Drug Interaction (DDI) Study of Selpercatinib and Dabigatran in Healthy Participants
Baseline characteristics by cohort
| Measure |
Dabigatran + Selpercatinib
n=36 Participants
Participants received a single oral dose of 150 milligrams (mg) dabigatran on Day 1 and a single oral dose of 150 mg dabigatran coadministered with a single oral dose of 2 x 80 mg (160 mg) Selpercatinib on Day 8. There was a washout period of 7 days between dosing on Days 1 and 8.
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|---|---|
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Age, Continuous
|
42.5 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 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
|
1 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
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 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
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36 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 and Day 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours (h) postdosePopulation: All participants who received at least one dose of dabigatran and had evaluable PK.
PK: Cmax of Dabigatran
Outcome measures
| Measure |
Dabigatran
n=36 Participants
Participants received a single oral dose of 150 milligrams (mg) dabigatran on Day 1.
|
Selpercatinib + Dabigatran
n=35 Participants
Participants received a single oral dose of 150 mg dabigatran coadministered with a single oral dose of 2 x 80 mg (160 mg) Selpercatinib on Day 8.
|
|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Dabigatran
|
192 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 41
|
276 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 36
|
PRIMARY outcome
Timeframe: Day 1 and Day 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h postdosePopulation: All participants who received at least one dose of dabigatran had evaluable PK.
PK: AUC(0-inf) of Dabigatran
Outcome measures
| Measure |
Dabigatran
n=36 Participants
Participants received a single oral dose of 150 milligrams (mg) dabigatran on Day 1.
|
Selpercatinib + Dabigatran
n=35 Participants
Participants received a single oral dose of 150 mg dabigatran coadministered with a single oral dose of 2 x 80 mg (160 mg) Selpercatinib on Day 8.
|
|---|---|---|
|
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Dabigatran
|
1650 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 42
|
2290 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 37
|
SECONDARY outcome
Timeframe: Day 8: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h postdosePopulation: All participants who received at least one dose of Selpercatinib and had evaluable PK.
PK: Cmax of Selpercatinib
Outcome measures
| Measure |
Dabigatran
n=35 Participants
Participants received a single oral dose of 150 milligrams (mg) dabigatran on Day 1.
|
Selpercatinib + Dabigatran
Participants received a single oral dose of 150 mg dabigatran coadministered with a single oral dose of 2 x 80 mg (160 mg) Selpercatinib on Day 8.
|
|---|---|---|
|
PK: Cmax of Selpercatinib
|
1830 ng/mL
Geometric Coefficient of Variation 23
|
—
|
SECONDARY outcome
Timeframe: Day 8: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h postdosePopulation: All participants who received at least one dose of Selpercatinib and had evaluable PK.
PK: AUC(0-inf) of Selpercatinib
Outcome measures
| Measure |
Dabigatran
n=35 Participants
Participants received a single oral dose of 150 milligrams (mg) dabigatran on Day 1.
|
Selpercatinib + Dabigatran
Participants received a single oral dose of 150 mg dabigatran coadministered with a single oral dose of 2 x 80 mg (160 mg) Selpercatinib on Day 8.
|
|---|---|---|
|
PK: AUC(0-inf) of Selpercatinib
|
25600 ng*h/mL
Geometric Coefficient of Variation 27
|
—
|
SECONDARY outcome
Timeframe: Day 8: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h postdosePopulation: All participants who received at least one dose of Selpercatinib and had evaluable PK.
PK: Tmax of Selpercatinib
Outcome measures
| Measure |
Dabigatran
n=35 Participants
Participants received a single oral dose of 150 milligrams (mg) dabigatran on Day 1.
|
Selpercatinib + Dabigatran
Participants received a single oral dose of 150 mg dabigatran coadministered with a single oral dose of 2 x 80 mg (160 mg) Selpercatinib on Day 8.
|
|---|---|---|
|
PK: Time of Maximum Observed Drug Concentration (Tmax) of Selpercatinib
|
3.00 hours
Interval 1.5 to 6.0
|
—
|
Adverse Events
150 mg Dabigatran
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
150 mg Dabigatran + 160 mg Selpercatinib
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60