Trial Outcomes & Findings for A Drug Drug Interaction (DDI) Study of Selpercatinib (LY3527723) and Rosuvastatin in Healthy Participants (NCT NCT05906836)
NCT ID: NCT05906836
Last Updated: 2025-09-16
Results Overview
PK: Cmax of Rosuvastatin was reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
28 participants
Primary outcome timeframe
Day 1 and Day 5: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours (h) post dose
Results posted on
2025-09-16
Participant Flow
Participant milestones
| Measure |
Rosuvastatin + Selpercatinib
Participants received 20 milligrams (mg) of rosuvastatin administered orally on Day 1, followed by 20 mg of rosuvastatin co-administered orally with 160 mg of selpercatinib on Day 5.
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Rosuvastatin + Selpercatinib
Participants received 20 milligrams (mg) of rosuvastatin administered orally on Day 1, followed by 20 mg of rosuvastatin co-administered orally with 160 mg of selpercatinib on Day 5.
|
|---|---|
|
Overall Study
Unwilling to Make Travel Arrangements
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
A Drug Drug Interaction (DDI) Study of Selpercatinib (LY3527723) and Rosuvastatin in Healthy Participants
Baseline characteristics by cohort
| Measure |
Rosuvastatin + Selpercatinib
n=28 Participants
Participants received 20 mg of rosuvastatin administered orally on Day 1, followed by 20 mg of rosuvastatin co-administered orally with 160 mg of selpercatinib on Day 5.
|
|---|---|
|
Age, Continuous
|
41.5 years
STANDARD_DEVIATION 12.3 • n=99 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
28 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Day 1 and Day 5: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours (h) post dosePopulation: All participants who received atleast one dose of rosuvastatin and had evaluable PK data for this outcome.
PK: Cmax of Rosuvastatin was reported.
Outcome measures
| Measure |
Rosuvastatin
n=27 Participants
Participants received 20 mg of rosuvastatin administered orally on Day 1.
|
Rosuvastatin + Selpercatinib
n=28 Participants
Participants received 20 mg of rosuvastatin co-administered orally with 160 mg of selpercatinib on Day 5.
|
|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Rosuvastatin
|
8.92 nanogram per millilitre (ng/mL)
Geometric Coefficient of Variation 59
|
15.2 nanogram per millilitre (ng/mL)
Geometric Coefficient of Variation 38
|
PRIMARY outcome
Timeframe: Day 1 and Day 5: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 h post dosePopulation: All participants who received atleast one dose of rosuvastatin and had evaluable PK data for this outcome.
PK: AUC(0-∞) of Rosuvastatin was reported.
Outcome measures
| Measure |
Rosuvastatin
n=23 Participants
Participants received 20 mg of rosuvastatin administered orally on Day 1.
|
Rosuvastatin + Selpercatinib
n=26 Participants
Participants received 20 mg of rosuvastatin co-administered orally with 160 mg of selpercatinib on Day 5.
|
|---|---|---|
|
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Rosuvastatin
|
81.9 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 70
|
151 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 44
|
Adverse Events
Rosuvastatin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Rosuvastatin + 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