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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-12

Study Completion Date

2018-09-18

Brief Summary

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The main purpose of this study is to assess the effect of selpercatinib on how fast midazolam 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 about 6 weeks, inclusive of screening period.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Period 1: Midazolam

* Day 1: Participants received single oral dose of 2 milligram (mg) midazolam syrup.

Group Type EXPERIMENTAL

Midazolam

Intervention Type DRUG

Administered orally.

Period 2: Selpercatinib + Midazolam

* Day 1 to Day 9: Participants received 160 mg Selpercatinib capsules twice daily (BID).
* Day 10: Participant received 160 mg Selpercatinib capsules BID co-administered with a single oral dose of 2 mg midazolam syrup on the morning of Day 10.

Group Type EXPERIMENTAL

Midazolam

Intervention Type DRUG

Administered orally.

Selpercatinib

Intervention Type DRUG

Administered orally.

Interventions

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Midazolam

Administered orally.

Intervention Type DRUG

Selpercatinib

Administered orally.

Intervention Type DRUG

Other Intervention Names

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LY3527723 LOXO-292

Eligibility Criteria

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Inclusion Criteria

* Male and female participants of non-childbearing potential who are agreeable to take birth control measures until study completion
* 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

Exclusion Criteria

* Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
* Have previously participated or withdrawn from this study
* Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
* Had blood loss of more than 500 milliliters (mL) within the previous 30 days of study screening
* Require treatment with inducers or inhibitors of cytochrome P450 (CYP) CYP3A within 14 days before the first dose of study drug through the end of Period 2

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes