Study of H2 Antagonist and a Proton Pump Inhibitor of Selpercatinib in Healthy Participants

Healthy Clinical Trial

Official title:

An Open-Label, 3-Period, Fixed Sequence Study to Evaluate the Effect of an H2 Antagonist and a Proton Pump Inhibitor on the Single Dose Pharmacokinetics of LOXO-292 in Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05338502
• Other study ID #: 17574
• Secondary ID: J2G-OX-JZJLLOXO-
• Status: Completed
• Phase: Phase 1
• Start date: July 8, 2019
• Est. completion date: September 3, 2019

Study information

• Verified date: January 2023
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 3, 2019
• Est. primary completion date: September 3, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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• Have previously participated or withdrawn from this study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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Selpercatinib
Administered orally.
• Ranitidine
Administered orally.
• Omeprazole
Administered orally.

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit, Inc.	Madison	Wisconsin

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 Selpercatinib	PK: AUC0-t of Selpercatinib	Pre-dose up to 168 hour post-dose (Days 1, 12, and 23)
Primary	PK: Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) of Selpercatinib	PK: AUC0-inf of Selpercatinib	Pre-dose up to 168 hour post-dose (Days 1, 12, and 23)
Primary	PK: Extrapolation for area under the concentration time curve (%AUCextrap) of Selpercatinib	PK: %AUCextrap of Selpercatinib	Pre-dose up to 168 hour post-dose (Days 1, 12, and 23)
Primary	PK: Maximum observed concentration (Cmax) of Selpercatinib	PK: Cmax of Selpercatinib	Pre-dose up to 168 hour post-dose (Days 1, 12, and 23)
Primary	PK: Time to reach Cmax (Tmax) of Selpercatinib	PK: Tmax of Selpercatinib	Pre-dose up to 168 hour post-dose (Days 1, 12, and 23)
Primary	PK: Elimination rate constant (?Z) of Selpercatinib	PK: ?Z of Selpercatinib	Pre-dose up to 168 hour post-dose (Days 1, 12, and 23)
Primary	PK: Apparent total plasma clearance after oral (extravascular) administration (CL/F) of Selpercatinib	PK: CL/F of Selpercatinib	Pre-dose up to 168 hour post-dose (Days 1, 12, and 23)
Primary	PK: Apparent first-order terminal elimination half-life (t½) of Selpercatinib	PK: t½ of Selpercatinib	Pre-dose up to 168 hour post-dose (Days 1, 12, and 23)