A Study of Effects of Selpercatinib (LY3527723) on Midazolam in Healthy Participants

Healthy Clinical Trial

Official title:

An Open-Label, Fixed-Sequence Study to Evaluate the Effect of Multiple Doses of LOXO-292 on the Single Dose Pharmacokinetics of Midazolam in Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05338476
• Other study ID #: 17753
• Secondary ID: J2G-OX-JZJRLOXO-
• Status: Completed
• Phase: Phase 1
• Start date: July 12, 2018
• Est. completion date: September 18, 2018

Study information

• Verified date: April 2022
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to assess the effect of selpercatinib on how fast midazolam 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 will last up to about 6 weeks, inclusive of screening period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 18, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria :

• Male and 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• Have previously participated or withdrawn from this study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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Midazolam
Administered orally.
• Selpercatinib
Administered orally.

Locations

Country	Name	City	State
United States	Celerion	Tempe	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Loxo Oncology, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (AUC0-t) of Midazolam	PK: AUC0-t of Midazolam	Days 1, 2, 10, and 11
Primary	PK: Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) of Midazolam	PK: AUC0-inf of Midazolam	Days 1, 2, 10, and 11
Primary	PK: Percent of AUC0-inf extrapolated (AUC%extrap) of Midazolam	PK: AUC%extrap of Midazolam	Days 1, 2, 10, and 11
Primary	PK: Maximum observed concentration (Cmax) of Midazolam	PK: Cmax of Midazolam	Days 1, 2, 10, and 11
Primary	PK: Time to reach Cmax (Tmax) of Midazolam	PK: Tmax of Midazolam	Days 1, 2, 10, and 11
Primary	PK: Apparent first-order terminal elimination rate constant (Kel) of Midazolam	PK: Kel of Midazolam	Days 1, 2, 10, and 11
Primary	PK: Apparent first-order terminal elimination half-life (t½) of Midazolam	PK: t½ of Midazolam	Days 1, 2, 10, and 11
Primary	PK: Apparent total plasma clearance after oral (extravascular) administration (CL/F) of Midazolam	PK: CL/F of Midazolam	Days 1, 2, 10, and 11
Primary	PK: Apparent volume of distribution during the terminal elimination phase (Vz/F) of Midazolam	PK: Vz/F of Midazolam	Days 1, 2, 10, and 11
Secondary	PK : Area under the concentration-time curve, from time 0 to the 12 hour (AUC0-12) of Selpercatinib	PK: AUC0-12 of Selpercatinib	Day 1
Secondary	PK: Area under the concentration-time curve during a dosing interval (tau) at steady state (AUCtau) of Selpercatinib	AUCtau of Selpercatinib	Days 1-11
Secondary	PK: Cmax of Selpercatinib	PK: Cmax of Selpercatinib	Days 1-11
Secondary	PK: Maximum observed concentration at steady-state (Cmax,ss) of Selpercatinib	PK: Cmax,ss of Selpercatinib	Days 1-11
Secondary	PK: Concentration observed at the end of the dosing interval (Ctrough) of Selpercatinib	PK: Ctrough of Selpercatinib	Days 1-11
Secondary	PK: Tmax of Selpercatinib	PK: Tmax of Selpercatinib	Days 1-11
Secondary	PK: Time to reach Cmax,ss (Tmax,ss) of Selpercatinib	PK: Tmax,ss of Selpercatinib	Days 1-11
Secondary	PK: Apparent total plasma clearance (CL,ss/F) of Selpercatinib	PK: CL,ss/F of Selpercatinib	Days 1-11