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

NCT ID: NCT05894928

Last Updated: 2023-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-07

Study Completion Date

2023-07-09

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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LOXO-783 alone

Single dose of LOXO-783 administered orally.

Group Type EXPERIMENTAL

LOXO-783

Intervention Type DRUG

Administered orally.

LOXO-783 + Cholestyramine 1 hour post dose

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

Group Type EXPERIMENTAL

LOXO-783

Intervention Type DRUG

Administered orally.

Cholestyramine

Intervention Type DRUG

Administered orally.

LOXO-783 + Cholestyramine 4 hours post dose

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

Group Type EXPERIMENTAL

LOXO-783

Intervention Type DRUG

Administered orally.

Cholestyramine

Intervention Type DRUG

Administered orally.

Interventions

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LOXO-783

Administered orally.

Intervention Type DRUG

Cholestyramine

Administered orally.

Intervention Type DRUG

Other Intervention Names

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LY3849524

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Females who are lactating or of childbearing potential
* Clinically significant history of any drug sensitivity, drug allergy, or food allergy
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Loxo Oncology, Inc.

INDUSTRY

Sponsor Role collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yingying Guo-Avrutin, MD; PhD

Role: STUDY_DIRECTOR

Loxo Oncology, Inc.

Locations

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Labcorp Clinical Research Unit

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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J4C-OX-JZUD

Identifier Type: OTHER

Identifier Source: secondary_id

LOXO-PIK-23009

Identifier Type: -

Identifier Source: org_study_id

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