A Study of Selpercatinib (LY3527723) in Healthy Participants

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05338515
• Collaborator: Loxo Oncology, Inc. (Industry)
• Enrollment: 18
• Location: 1
• Arms: 3
• Actual Duration (Months): 1.4
• Patients Per Site Per Month: 13

Study Details

Study Description

Brief Summary

The main purpose of this study is to determine how safe and how well tolerated selpercatinib is when given as oral doses to healthy participants. The study will also assess how fast selpercatinib gets into the blood stream and how long it takes the body to remove it. The study will last up to about 6 weeks, inclusive of screening period.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A Phase I, Single-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LOXO-292 in Healthy Adult Subjects
• Actual Study Start Date: Feb 12, 2019
• Actual Primary Completion Date: Mar 12, 2019
• Actual Study Completion Date: Mar 26, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Selpercatinib Cohort 1 Selpercatinib administered orally.	Drug: Selpercatinib; Administered orally.; Other Names: LY3527723 LOXO-292
Experimental: Selpercatinib Cohort 2 Selpercatinib administered orally.	Drug: Selpercatinib; Administered orally.; Other Names: LY3527723 LOXO-292
Experimental: Selpercatinib Cohort 3 Selpercatinib administered orally.	Drug: Selpercatinib; Administered orally.; Other Names: LY3527723 LOXO-292

Outcome Measures

Primary Outcome Measures

1. Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [Baseline through Day 8]

   A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary Outcome Measures

1. 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

2. PK: Area under the concentration-time curve, from time 0 to Hour 24 (AUC0-24) of Selpercatinib [Pre-dose up to 168 hour post-dose]

   PK: AUC0-24 of Selpercatinib

3. 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

4. PK: Percent of AUC0-inf extrapolated (AUC%extrap) of Selpercatinib [Pre-dose up to 168 hour post-dose]

   PK: AUC%extrap of Selpercatinib

5. 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

6. PK: Maximum observed concentration (Cmax) of Selpercatinib [Pre-dose up to 168 hour post-dose]

   PK: Cmax of Selpercatinib

7. PK: Time to reach Cmax (Tmax) of Selpercatinib [Pre-dose up to 168 hour post-dose]

   PK: Tmax of Selpercatinib

8. PK: Apparent first-order terminal elimination rate constant (Kel) of Selpercatinib [Pre-dose up to 168 hour post-dose]

   PK: Kel of Selpercatinib

9. PK: Apparent volume of distribution during the terminal elimination phase (Vz/F) of Selpercatinib [Pre-dose up to 168 hour post-dose]

   PK: Vz/F 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: NCT05338515
• Other Study ID Numbers: 17485; J2G-OX-JZJF; LOXO-RET-18057
• First Posted: Apr 21, 2022
• Last Update Posted: Apr 21, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Apr 21, 2022