Healthy
Conditions
Keywords
Drug Drug Interaction Trial, Selpercatinib (Retevmo®)
Brief summary
The main purpose of this study is to determine the effect of selpercatinib on the levels of rosuvastatin in the blood stream in healthy participants. This study also evaluated the safety and tolerability of rosuvastatin when administered in combination with selpercatinib in healthy participants. This study will last up to approximately 26 days excluding screening period.
Interventions
DRUGRosuvastatin
Administered orally.
DRUGSelpercatinib
Administered orally.
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants who are overtly healthy as determined by medical evaluation * Participant must be Caucasian * Body mass index (BMI) within the range of 19.0 to 32.0 kilograms per meter squared (kg/m²)
Exclusion criteria
* Have known allergies to selpercatinib-related compounds or any components of the formulation of selpercatinib, or or rosuvastatin * • Have a significant previous or current history or presence of cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product * Have used or are intending to use over-the-counter or prescription medication, including dietary supplements and herbal medications, within 14 days prior to dosing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Rosuvastatin | 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 | PK: Cmax of Rosuvastatin was reported. |
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Rosuvastatin | 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 dose | PK: AUC(0-∞) of Rosuvastatin was reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rosuvastatin + Selpercatinib 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. | 28 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Unwilling to Make Travel Arrangements | 1 |
Baseline characteristics
| Characteristic | Rosuvastatin + Selpercatinib |
|---|---|
| Age, Continuous | 41.5 years STANDARD_DEVIATION 12.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 27 Participants |
| Region of Enrollment United States | 28 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 28 |
| other Total, other adverse events | 0 / 28 | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 | 0 / 28 |
Outcome results
Primary
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Rosuvastatin
PK: Cmax of Rosuvastatin was reported.
Time frame: 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
Population: All participants who received atleast one dose of rosuvastatin and had evaluable PK data for this outcome.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Rosuvastatin | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Rosuvastatin | 8.92 nanogram per millilitre (ng/mL) | Geometric Coefficient of Variation 59 |
| Rosuvastatin + Selpercatinib | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Rosuvastatin | 15.2 nanogram per millilitre (ng/mL) | Geometric Coefficient of Variation 38 |
Primary
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Rosuvastatin
PK: AUC(0-∞) of Rosuvastatin was reported.
Time frame: 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 dose
Population: All participants who received atleast one dose of rosuvastatin and had evaluable PK data for this outcome.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Rosuvastatin | 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 |
| Rosuvastatin + Selpercatinib | PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Rosuvastatin | 151 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 44 |