A Study of Effects of Itraconazole and Rifampin on Selpercatinib (LY3527723) in Healthy Participants

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Completed

CT.gov ID

NCT05338489

Collaborator

Loxo Oncology, Inc. (Industry)

Enrollment

Location

Arms

3.4

Actual Duration (Months)

7.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Selpercatinib Drug: Itraconazole Drug: Rifampin	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

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

Actual Study Start Date :

May 11, 2018

Actual Primary Completion Date :

Jul 28, 2018

Actual Study Completion Date :

Aug 22, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Selpercatinib - Part 1 Period 1 Selpercatinib administered orally.	Drug: Selpercatinib Administered orally. Other Names: LY3527723 LOXO-292
Experimental: Selpercatinib and Itraconazole - Part 1 Period 2 Selpercatinib and itraconazole administered orally.	Drug: Selpercatinib Administered orally. Other Names: LY3527723 LOXO-292 Drug: Itraconazole Administered orally.
Experimental: Selpercatinib - Part 2 Period 1 Selpercatinib administered orally.	Drug: Selpercatinib Administered orally. Other Names: LY3527723 LOXO-292
Experimental: Selpercatinib and Rifampin - Part 2 Period 2 Selpercatinib and rifampin administered orally.	Drug: Selpercatinib Administered orally. Other Names: LY3527723 LOXO-292 Drug: Rifampin Administered orally.

Outcome Measures

Primary Outcome Measures

Pharmacokinetics (PK): Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (AUC0-t) of Selpercatinib [Pre-dose up to 168 hour post-dose]
PK: AUC0-t of Selpercatinib
PK: Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) of Selpercatinib [Pre-dose up to 168 hour post-dose]
PK: AUC0-inf of Selpercatinib
PK: Percent of AUC0-inf extrapolated (AUC%extrap) of Selpercatinib [Pre-dose up to 168 hour post-dose]
PK: AUC%extrap of Selpercatinib
PK: Maximum observed concentration (Cmax) of Selpercatinib [Pre-dose up to 168 hour post-dose]
PK: Cmax of Selpercatinib
PK: Time to reach Cmax (Tmax) of Selpercatinib [Pre-dose up to 168 hour post-dose]
PK: Tmax of Selpercatinib
PK: Apparent first-order terminal elimination rate constant (Kel) of Selpercatinib [Pre-dose up to 168 hour post-dose]
PK: Kel of Selpercatinib
PK: Apparent total plasma clearance after oral (extravascular) administration (CL/F) of Selpercatinib [Pre-dose up to 168 hour post-dose]
PK: CL/F of Selpercatinib
PK: Apparent first-order terminal elimination half-life (t½) of Selpercatinib [Pre-dose up to 168 hour post-dose]
PK: t½ of Selpercatinib
PK: area under the concentration-time curve, from time 0 to the 24 hours (AUC0-24) of Selpercatinib [Day 1]
PK: AUC0-24 of Selpercatinib

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Celerion	Tempe	Arizona	United States	85283

Sponsors and Collaborators

Eli Lilly and Company
Loxo Oncology, Inc.

Investigators

Study Director: 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), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT05338489

Other Study ID Numbers:

17751
J2G-OX-JZJP
LOXO-RET-18014

First Posted:

Apr 21, 2022

Last Update Posted:

Apr 21, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Itraconazole

Rifampin

Study Results

No Results Posted as of Apr 21, 2022