Clinical trial NCT05338489: A Study of Effects of Itraconazole and Rifampin on Selpercatinib (LY3527723) in Healthy Participants
Official title: A 2-Part, Open-Label, Fixed-Sequence Study to Evaluate the Effects of Multiple Doses of Itraconazole and Rifampin on the Single-Dose Pharmacokinetics of LOXO-292 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Loxo Oncology, Inc.
First posted: 2022-04-21
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to assess the effect of itraconazole and rifampin on how fast selpercatinib gets into the blood stream and how long it takes the body to remove it when administered in healthy participants. Information about safety and tolerability will be collected. The study is conducted in two parts and it will last up to 54 days (part 1) and 59 days (part 2), respectively, inclusive of screening period.


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* Have previously participated or withdrawn from this study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

Primary outcomes:
measure: Pharmacokinetics (PK): Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (AUC0-t) of Selpercatinib
timeFrame: Pre-dose up to 168 hour post-dose
measure: PK: Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) of Selpercatinib
timeFrame: Pre-dose up to 168 hour post-dose
measure: PK: Percent of AUC0-inf extrapolated (AUC%extrap) of Selpercatinib
timeFrame: Pre-dose up to 168 hour post-dose
measure: PK: Maximum observed concentration (Cmax) of Selpercatinib
timeFrame: Pre-dose up to 168 hour post-dose
measure: PK: Time to reach Cmax (Tmax) of Selpercatinib
timeFrame: Pre-dose up to 168 hour post-dose
measure: PK: Apparent first-order terminal elimination rate constant (Kel) of Selpercatinib
timeFrame: Pre-dose up to 168 hour post-dose
measure: PK: Apparent total plasma clearance after oral (extravascular) administration (CL/F) of Selpercatinib
timeFrame: Pre-dose up to 168 hour post-dose
measure: PK: Apparent first-order terminal elimination half-life (t½) of Selpercatinib
timeFrame: Pre-dose up to 168 hour post-dose
measure: PK: area under the concentration-time curve, from time 0 to the 24 hours (AUC0-24) of Selpercatinib
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion
state: Arizona
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: