A Study of Effects of Selpercatinib (LY3527723) on Repaglinide in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Selpercatinib; Drug: Repaglinide

Study type: Interventional

Funder types: Industry

Identifiers

NCT05469113

17754

LOXO-RET-18026 (Other Identifier)

J2G-OX-JZJS (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to assess the effect of selpercatinib on how fast repaglinide gets into the blood stream and how long it takes the body to remove it when administered in healthy participants. Information about safety and tolerability will be collected. The study will last up to 12 days.

Enrollment: 16 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kilograms per meter squared (kg/m²) and had a minimum weight of at least 50 kg at screening
• Have normal blood pressure, pulse rate, electrocardiogram (ECG), and blood and urine laboratory test results that are acceptable for the study
• Hemoglobin (Hb) A1c value < 6.5 % at screening and fasting glucose ≤ 126 mg/dL.
• Males who are capable of fathering a child must agree to use one of the following methods of contraception from the time of the dose administration through 6 months after the last dose
• Female of non-childbearing potential only or must have undergone sterilization procedures at least 6months prior to the first dosing

Exclusion criteria

• History or presence of diabetes or history of prior episode(s) of hypoglycemia.
• Estimated creatinine clearance <90 mL/min at Screening or Check-in (Day -1, Period 1)
• Unable to refrain from or anticipates the use of any drug, including prescription and non prescription medications, herbal remedies, or vitamin supplements for 14 days prior to the first dosing and through EOT or ET. After first dosing, acetaminophen (up to 2 g per 24 hours) may be administered at the discretion of the PI or designee

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Period 1: Repaglinide

Experimental group

Description:

* Day 1: Participants received single dose of 0.5 mg repaglinide tablet.

Treatment:

Drug: Repaglinide

Period 2: Selpercatinib + Repaglinide

Experimental group

Description:

* Day 1 to Day 9: Participants received 160 mg Selpercatinib capsule twice daily (BID). * Day 10: Participant received 160 mg Selpercatinib capsules BID co-administered with a single oral dose of 0.5 mg Repaglinide tablet on the morning of Day 10.

Treatment:

Drug: Repaglinide

Drug: Selpercatinib