Study That Evaluates the Effect of CYP3A4 Inhibition on Lu AG06466 in Healthy Men and Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-20

Study Completion Date

2020-07-28

Brief Summary

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A study to learn how a drug (itraconazole) that is known to inhibit a certain enzym in the liver, impacts the body's ability to breakdown Lu AG06466 into breakdown products in healthy men and women. The main breakdown product is Lu AG06988.

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Detailed Description

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Two sequence study where Lu AG06466 will be dosed with and without food, Sequence 1 and Sequence 2. Each subject will receive single oral doses of Lu AG06466. Subject will be randomized to one of two sequences.

For inhibition of CYP3A4, each subject will receive a once daily dosage of itraconazole from Day 5 to Day 11.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lu AG06466 - Sequence 1

Dosing on Days 1 and 8 will be following an overnight fast, and dosing on Days 3 and 10 will be following a standard high-fat breakfast.

Group Type EXPERIMENTAL

Lu AG06466

Intervention Type DRUG

hard capsules, orally, single doses

Itraconazole

Intervention Type DRUG

200 and 300 mg, capsules, orally

Lu AG06466 - Sequence 2

Dosing on Days 1 and 8 will be following, a standard high-fat breakfast and dosing on Days 3 and 10 will be following an overnight fast.

Group Type EXPERIMENTAL

Lu AG06466

Intervention Type DRUG

hard capsules, orally, single doses

Itraconazole

Intervention Type DRUG

200 and 300 mg, capsules, orally

Interventions

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Lu AG06466

hard capsules, orally, single doses

Intervention Type DRUG

Itraconazole

200 and 300 mg, capsules, orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* The subject has a BMI ≥18.5 and ≤30 kg/m2
* The subject is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, a neurological examination, vital signs, an electrocardiogram (ECG), and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.
* The subject must not be of childbearing potential (if a woman) or should use contraception (both sexes). If women, the subject must not be pregnant or breastfeeding.