Study of the Effects of Itraconazole and Carbamazepine on LY3410738 in Healthy Participants

NCT05205447 | Terminated Phase 1 FDA Drug

• 2 other identifiers: LOXO-IDH-21005I9Y-OX-JDHF
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to learn about how itraconazole and carbamazepine affect the levels of LY3410738 in the blood stream of healthy participants. Participation could last up to 75 days.

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• Assess the impact of multiple oral doses of itraconazole on single oral dose pharmacokinetics (PK) of LY3410738 by collecting/evaluating serum at protocol-specified time points: Maximum observed plasma concentration (Cmax)

  PK of LY3410738

  Pre-dose up to 96 hours post-dose

• Assess the impact of multiple oral doses of itraconazole on single oral dose PK of LY3410738 by collecting/evaluating serum at protocol-specified time points: Area under the concentration-time curve from Hour 0 to last measurable concentration (AUC0-t)

  PK of LY3410738

  Pre-dose up to 96 hours post-dose

• Assess the impact of multiple oral doses of itraconazole on single oral dose PK of LY3410738 by collecting/evaluating serum at protocol-specified time points: Area under the concentration-time curve extrapolated to infinity (AUC0-inf)

  PK of LY3410738

  Pre-dose up to 96 hours post-dose

• Assess the effect of multiple oral doses of carbamazepine on single oral dose PK of LY3410738 by collecting/evaluating serum at protocol-specified time points: Cmax

  PK of LY3410738

  Pre-dose up to 96 hours post-dose

• Assess the effect of multiple oral doses of carbamazepine on single oral dose PK of LY3410738 by collecting/evaluating serum at protocol-specified time points: AUC0-t

  PK of LY3410738

  Pre-dose up to 96 hours post-dose

• Assess the effect of multiple oral doses of carbamazepine on single oral dose PK of LY3410738 by collecting/evaluating serum at protocol-specified time points: AUC0-inf

  PK of LY3410738

  Pre-dose up to 96 hours post-dose

Study Arms (4)

Part 1 Period 1 (LY3410738 Alone)

EXPERIMENTAL

Single dose of LY3410738 administered orally.

Drug: LY3410738

Part 1 Period 2 (LY3410738 + Itraconazole)

EXPERIMENTAL

Single dose of LY3410738 administered orally with multiple doses of itraconazole orally.

Drug: LY3410738; Drug: Itraconazole

Part 2 Period 1 (LY3410738 Alone)

EXPERIMENTAL

Single dose of LY3410738 administered orally.

Drug: LY3410738

Part 2 Period 2 (LY3410738 + Carbamazepine)

EXPERIMENTAL

Single dose of LY3410738 administered orally with multiple doses of carbamazepine orally.

Drug: LY3410738; Drug: Carbamazepine

Interventions

LY3410738 DRUG

Oral LY3410738

Part 1 Period 1 (LY3410738 Alone); Part 1 Period 2 (LY3410738 + Itraconazole); Part 2 Period 1 (LY3410738 Alone); Part 2 Period 2 (LY3410738 + Carbamazepine)

Itraconazole DRUG

Oral Itraconazole

Part 1 Period 2 (LY3410738 + Itraconazole)

Carbamazepine DRUG

Oral Carbamazepine

Part 2 Period 2 (LY3410738 + Carbamazepine)

Eligibility Criteria

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

You may qualify if:

• Females of non-childbearing potential and males capable of fathering a child must use contraception
• Within body mass index (BMI) range 18.0 to 32.0 kilograms per square meter (kg/m²).
• Participants will be in good health, based on medical history, physical examination findings, vital signs, 12 lead electrocardiogram (ECG), or clinical laboratory tests, as determined by the Investigator (or designee).
• Able to comply with all study procedures, including the 15-night stay for those participating in part 1 or 25-night stay for those participating in part 2 at the Clinical Research Unit and follow-up phone call.

You may not qualify if:

• History or presence of any of the following, deemed clinically significant by the Investigator (or designee), and/or Sponsor:
• Allergic disease
• Dermatological disease
• Renal disease
• Liver disease
• Pancreatitis
• Gastrointestinal disease
• Biliary disease
• Metabolic disease
• Hematological disease
• Pulmonary disease
• Neurological disease
• Cancer within the past 5 years
• Cardiovascular disease
• Participants with out-of-range, at-rest vital signs.

Sponsors & Collaborators

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

Study Sites (1)

LabCorp CRU, Inc.

Daytona Beach, Florida, 32117, United States

Location

MeSH Terms

Interventions

Itraconazole; Carbamazepine

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Yingying Guo

  Medical Monitor

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: January 25, 2022
• Study Start: January 5, 2022
• Primary Completion: April 12, 2022
• Study Completion: April 12, 2022
• Last Updated: December 28, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)