A Study of [14C]-LOXO-783 in Healthy Adult Participants

Healthy Clinical Trial

Official title:

A Phase 1, Open-label Two-part Study of the Absorption, Metabolism, Excretion, and the Absolute Bioavailability of [14C]-LOXO-783 in Healthy Adult Subjects

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06102512
• Other study ID #: LOXO-PIK-23005
• Secondary ID: J4C-OX-JZUE
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: October 23, 2023
• Est. completion date: January 11, 2024

Study information

• Verified date: October 2023
• Source: Eli Lilly and Company
• Contact: Patient Advocacy
• Phone: 8555696305
• Email: clinicaltrials[@]loxooncology.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to evaluate how much of the study drug, the radioactive substance 14C incorporated LOXO-783 ([¹⁴C]-LOXO-783) passes from blood into urine, feces and expired air in healthy adult participants when administered as a single dose. The study will also measure how much of the LOXO-783 and [¹⁴C]-LOXO-783 gets into the bloodstream, how its broken down, and how long it takes the body to get rid of it. The study is conducted in two parts and will last up to approximately 72 and 61 days for part 1 and 2, respectively.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: January 11, 2024
• Est. primary completion date: January 11, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Male and female participants in good health, determined by no clinically significant findings from medical history, physical examination, ECGs, vital signs, and clinical laboratory evaluations as assessed by the investigator

• Have a body mass index within the range 18.5 to 32.0 kilograms per meter squared (kg/m²)

• Female participants of non-childbearing potential and male participants who follow standard contraceptive methods

Exclusion Criteria:

• History or presence of any diseases or conditions of clinical significance by the Investigator (or designee) and/or Sponsor

• Known ongoing alcohol and/or drug abuse within 2 years prior to Screening

• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• [¹4C]-LOXO-783
Administered orally
• LOXO-783
Administered orally
• [¹4C]-LOXO-783
Administered IV

Locations

Country	Name	City	State
United States	Fortrea Clinical Research	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Loxo Oncology, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Fraction of Dose Excreted in Urine (Feur)	PK: Feur	Predose on day 1 up to postdose on day 21 (Part 1)
Primary	PK: Cumulative Feur	PK: Cumulative Feur	Predose on day 1 up to postdose on day 21 (Part 1)
Primary	PK: Fraction of Dose Excreted in Feces (Fefeces)	PK: Fefeces	Predose on day 1 up to postdose on day 21 (Part 1)
Primary	PK: Cumulative Fefeces	PK: Cumulative Fefeces	Predose on day 1 up to postdose on day 21 (Part 1)
Primary	PK: Fraction of Dose Excreted in Expired Air (Feair)	PK: Feair	Predose on day 1 up to postdose on day 21 (Part 1)
Primary	PK: Absolute Bioavailability (F) of LOXO-783	PK: F of LOXO-783	Predose on day 1 up to postdose on day 9 (Part 2)