A Study to Evaluate the Effect of Cholestyramine on LOXO-783 in Healthy Participants

NCT05894928 | Completed Phase 1 FDA Drug

• 2 other identifiers: LOXO-PIK-23009J4C-OX-JZUD
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to conduct blood tests to measure how much LOXO-783 is in the bloodstream and how the body handles and eliminates LOXO-783 when administered alone or in combination with cholestyramine in healthy participants. The study will also evaluate the safety and tolerability of LOXO-783 with and without cholestyramine. Participation could last up to 63 days including screening period.

Conditions

Healthy

Keywords

Cholestyramine; LOXO-783

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LOXO-783

  PK: Cmax of LOXO-783

  Predose on Day 1 upto 96 hours postdose of each treatment period

• PK: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC[0-inf]) of LOXO-783

  PK: AUC(0-inf) of LOXO-783

  Predose on Day 1 upto 96 hours postdose of each treatment period

Study Arms (3)

LOXO-783 alone

EXPERIMENTAL

Single dose of LOXO-783 administered orally.

Drug: LOXO-783

LOXO-783 + Cholestyramine 1 hour post dose

EXPERIMENTAL

Single dose of LOXO-783 administered orally followed by a single dose of cholestyramine administered orally after 1 hour.

Drug: LOXO-783; Drug: Cholestyramine

LOXO-783 + Cholestyramine 4 hours post dose

EXPERIMENTAL

Single dose of LOXO-783 administered orally followed by a single dose of cholestyramine administered orally after 4 hours.

Drug: LOXO-783; Drug: Cholestyramine

Interventions

LOXO-783 DRUG

Administered orally.

Also known as: LY3849524

LOXO-783 + Cholestyramine 1 hour post dose; LOXO-783 + Cholestyramine 4 hours post dose; LOXO-783 alone

Cholestyramine DRUG

Administered orally.

LOXO-783 + Cholestyramine 1 hour post dose; LOXO-783 + Cholestyramine 4 hours post dose

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy status as defined by the absence of evidence of any clinically significant active or chronic disease
• Body mass index (BMI): 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive

You may not qualify if:

• Females who are lactating or of childbearing potential
• Clinically significant history of any drug sensitivity, drug allergy, or food allergy

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Loxo Oncology, Inc.: collaborator

Study Sites (1)

Labcorp Clinical Research Unit

Dallas, Texas, 75247, United States

Location

MeSH Terms

Interventions

Cholestyramine Resin

Intervention Hierarchy (Ancestors)

Polystyrenes; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Yingying Guo-Avrutin, MD; PhD

  Loxo Oncology, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 8, 2023
• Study Start: June 7, 2023
• Primary Completion: July 9, 2023
• Study Completion: July 9, 2023
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)