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

NCT ID: NCT05205447

Last Updated: 2022-12-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-05
• Study Completion Date: 2022-04-12

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Part 1 Period 1 (LY3410738 Alone)

Single dose of LY3410738 administered orally.

Group Type: EXPERIMENTAL

LY3410738

Intervention Type: DRUG

Oral LY3410738

Part 1 Period 2 (LY3410738 + Itraconazole)

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

Group Type: EXPERIMENTAL

LY3410738

Intervention Type: DRUG

Oral LY3410738

Itraconazole

Intervention Type: DRUG

Oral Itraconazole

Part 2 Period 1 (LY3410738 Alone)

Single dose of LY3410738 administered orally.

Group Type: EXPERIMENTAL

LY3410738

Intervention Type: DRUG

Oral LY3410738

Part 2 Period 2 (LY3410738 + Carbamazepine)

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

Group Type: EXPERIMENTAL

LY3410738

Intervention Type: DRUG

Oral LY3410738

Carbamazepine

Intervention Type: DRUG

Oral Carbamazepine

Interventions

LY3410738

Oral LY3410738

Intervention Type: DRUG

Itraconazole

Oral Itraconazole

Intervention Type: DRUG

Carbamazepine

Oral Carbamazepine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• History or presence of any of the following, deemed clinically significant by the Investigator (or designee), and/or Sponsor:

1. Allergic disease

2. Dermatological disease

3. Renal disease

4. Liver disease

5. Pancreatitis

6. Gastrointestinal disease

7. Biliary disease

8. Metabolic disease

9. Hematological disease

10. Pulmonary disease

11. Neurological disease

12. Cancer within the past 5 years

13. Cardiovascular disease

• Participants with out-of-range, at-rest vital signs.
• Abnormal laboratory values determined to be clinically significant by the Investigator (or designee).
• Clinically significant abnormality, as determined by the Investigator (or designee), from physical examination.
• Participation in any other investigational study drug trial involving administration of any investigational drug in the past 30 days or 5 half-lives, whichever was longer, prior to the first dose administration (Day 1).
• Use or intention to use any prescription or over-the-counter medications within 14 days or 5 half-lives (if known) prior to the first dose administration (Day 1) and through end of trial.
• History or presence of any illness or psychiatric condition, that, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results, or put the participant at undue risk.
• Donation of blood from 56 days prior to Screening, plasma or platelets from 4 weeks prior to Screening.
• Receipt of blood products within 2 months prior to Check-in (Day -1).
• Significant history of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
• For Part 1 only, Having impaired hearing or a history of hearing problems
• For Part 2 only, History of serious dermatological adverse reaction, such as toxic epidermal necrolysis, Stevens-Johnson syndrome, or DRESS
• For Part 2 only, Glaucoma or history of elevated intraocular pressure.
• For Part 2 only, Have answered 'yes' to either Question 4 or Question 3 on the 'Suicidal Ideation' portion of the Columbia Suicide Severity Rating Scale (C-SSRS) or have answered 'yes' to any of the suicide-related behaviors on the 'Suicidal Behavior' portion of the C-SSRS
• For Part 2 only, Have laboratory evidence of clinically significant anemia, leukopenia, thrombocytopenia, or hepatic dysfunction; or hyponatremia
• For Part 2 only, Genotyping test that is positive for either or both of the carbamazepine sensitivity conferring HLA alleles
• Creatinine clearance < 90 mL/minute calculated using the C-G equation at Screening or Check-in
• Known ongoing alcohol and/or drug abuse within 2 years prior to Screening, or evidence of such abuse as indicated by the laboratory assays for drugs of abuse (including cotinine and alcohol) conducted during Screening and/or at Check-in (Day- 1).
• Consumption of foods or beverages containing grapefruit/grapefruit juice or Seville oranges or their juice within 7 days prior to Check-in (Day -1) and through end of treatment (EOT) or early termination (ET)
• Have previously completed or withdrawn from this study or any other study investigating LY3410738, and have previously received LY3410738

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Loxo Oncology, Inc.

INDUSTRY

Sponsor Role: collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yingying Guo

Role: STUDY_DIRECTOR

Medical Monitor

Locations

LabCorp CRU, Inc.

Daytona Beach, Florida, United States

Countries

United States

Other Identifiers

I9Y-OX-JDHF

Identifier Type: OTHER

Identifier Source: secondary_id

LOXO-IDH-21005

Identifier Type: -

Identifier Source: org_study_id