Phase 1
Completed N=20
Study of H2 Antagonist and a Proton Pump Inhibitor of Selpercatinib in Healthy Participants
Healthy
Source: ClinicalTrials.gov NCT05338502 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to the Last Observed Non-zero Concentration (AUC0-t) of Selpercatinib — 21600; 19100; 21000 hour*nanograms per milliliter(h*ng/mL)
Summary
The main purpose of this study is to learn about how H2 antagonist (ranitidine) and proton pump inhibitor (PPI) (omeprazole) affect Selpercatinib in healthy participants. Information about safety and tolerability will be collected. The study will last up to about 9 weeks, inclusive of screening period.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to the Last Observed Non-zero Concentration (AUC0-t) of Selpercatinib |
21600; 19100; 21000 | — |
| PRIMARY PK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Selpercatinib |
21800; 19900; 21100 | — |
| PRIMARY PK: Percentage of Area Under the Plasma Concentration-Time Curve (AUC) That is Due to Extrapolation From Last Measurable Concentration to Infinity (%AUCextrap) of Selpercatinib |
0.337; 0.818; 0.612 | — |
| PRIMARY PK: Maximum Observed Plasma Concentration (Cmax) of Selpercatinib |
1650; 1330; 1220 | — |
| PRIMARY PK: Time of Maximum Observed Concentration (Tmax) of Selpercatinib |
2.00; 1.83; 3.00 | — |
| PRIMARY PK: Apparent Volume of Distribution (Vz/F) |
259; 331; 300 | — |
| PRIMARY PK: Apparent Total Plasma Clearance After Oral (Extravascular) Administration (CL/F) of Selpercatinib |
7.35; 8.03; 7.58 | — |
| PRIMARY PK: Apparent Terminal Elimination Half-life (t½) of Selpercatinib |
24.4; 29.3; 27.4 | — |
Eligibility Criteria
Inclusion Criteria
- Male or 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 (NCT05338502). 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.