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

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Completed

CT.gov ID

NCT05338502

Collaborator

Loxo Oncology, Inc. (Industry)

Enrollment

Location

Arms

1.9

Actual Duration (Months)

10.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Selpercatinib Drug: Ranitidine Drug: Omeprazole	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

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

Actual Study Start Date :

Jul 8, 2019

Actual Primary Completion Date :

Sep 3, 2019

Actual Study Completion Date :

Sep 3, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Selpercatinib Selpercatinib administered orally.	Drug: Selpercatinib Administered orally. Other Names: LY3527723 LOXO-292
Experimental: Ranitidine Ranitidine administered orally.	Drug: Ranitidine Administered orally.
Experimental: Selpercatinib + Ranitidine Selpercatinib and ranitidine administered orally.	Drug: Selpercatinib Administered orally. Other Names: LY3527723 LOXO-292 Drug: Ranitidine Administered orally.
Experimental: Omeprazole Omeprazole administered orally.	Drug: Omeprazole Administered orally.
Experimental: Selpercatinib + Omeprazole Selpercatinib and omeprazole administered orally.	Drug: Selpercatinib Administered orally. Other Names: LY3527723 LOXO-292 Drug: Omeprazole 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 (Days 1, 12, and 23)]
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 (Days 1, 12, and 23)]
PK: AUC0-inf of Selpercatinib
PK: Extrapolation for area under the concentration time curve (%AUCextrap) of Selpercatinib [Pre-dose up to 168 hour post-dose (Days 1, 12, and 23)]
PK: %AUCextrap of Selpercatinib
PK: Maximum observed concentration (Cmax) of Selpercatinib [Pre-dose up to 168 hour post-dose (Days 1, 12, and 23)]
PK: Cmax of Selpercatinib
PK: Time to reach Cmax (Tmax) of Selpercatinib [Pre-dose up to 168 hour post-dose (Days 1, 12, and 23)]
PK: Tmax of Selpercatinib
PK: Elimination rate constant (λZ) of Selpercatinib [Pre-dose up to 168 hour post-dose (Days 1, 12, and 23)]
PK: λZ of Selpercatinib
PK: Apparent total plasma clearance after oral (extravascular) administration (CL/F) of Selpercatinib [Pre-dose up to 168 hour post-dose (Days 1, 12, and 23)]
PK: CL/F of Selpercatinib
PK: Apparent first-order terminal elimination half-life (t½) of Selpercatinib [Pre-dose up to 168 hour post-dose (Days 1, 12, and 23)]
PK: t½ 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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Covance Clinical Research Unit, Inc.	Madison	Wisconsin	United States	53704

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:

NCT05338502

Other Study ID Numbers:

17574
J2G-OX-JZJL
LOXO-RET-19075

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:

Omeprazole

Ranitidine

Ranitidine bismuth citrate

Study Results

No Results Posted as of Apr 21, 2022