Phase 1
Completed N=18
A Study of Selpercatinib (LY3527723) in Healthy Participants
Healthy
Source: ClinicalTrials.gov NCT05338515 ↗
Enrolled (actual)
18
Serious AEs
0.0%
Results posted
May 2025
Primary outcomePrimary: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration — 0; 0; 0 participants
Summary
The main purpose of this study is to determine how safe and how well tolerated selpercatinib is when given as oral doses to healthy participants. The study will also assess how fast selpercatinib gets into the blood stream and how long it takes the body to remove it. The study will last up to about 6 weeks, inclusive of screening period.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration |
0; 0; 0 | — |
| SECONDARY Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to the Last Observed Non-zero Concentration (AUC0-t) of Selpercatinib |
35900; 50460; 60960 | — |
| SECONDARY PK: Area Under the Concentration-time Curve, From Time 0 to Hour 24 (AUC0-24) of Selpercatinib |
21280; 30680; 36450 | — |
| SECONDARY PK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Selpercatinib |
36080; 50770; 61380 | — |
| SECONDARY PK: Percent of AUC0-inf Extrapolated (AUC%Extrap) of Selpercatinib |
0.5159; 0.6238; 0.6869 | — |
| SECONDARY PK: Apparent Total Plasma Clearance After Oral (Extravascular) Administration (CL/F) of Selpercatinib |
10.16; 13.62; 12.79 | — |
| SECONDARY PK: Maximum Observed Concentration (Cmax) of Selpercatinib |
2282; 3316; 3745 | — |
| SECONDARY PK: Time to Reach Cmax (Tmax) of Selpercatinib |
2.001; 1.999; 2.753 | — |
| SECONDARY PK: Apparent First-order Terminal Elimination Rate Constant (Kel) of Selpercatinib |
0.03122; 0.02607; 0.02562 | — |
| SECONDARY PK: Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of Selpercatinib |
328.7; 526.3; 487.0 | — |
Eligibility Criteria
Inclusion Criteria
- Female participants of non-childbearing potential who are agreeable to take birth control measures until study completion
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kilograms per meter squared (kg/m²) and had a minimum weight of at least 50 kg at screening
- Have normal blood pressure, pulse rate, electrocardiogram (ECG), and blood and urine laboratory test results that are acceptable for the study
Exclusion Criteria
- Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
- Have previously participated or withdrawn from this study
- Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
- Had blood loss of more than 500 milliliters (mL) within the previous 30 days of study screening
- Require treatment with inducers or inhibitors of cytochrome P450 (CYP) CYP3A within 14 days before the first dose of study drug through the end of Period 2
Data sourced from ClinicalTrials.gov (NCT05338515). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.