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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Lu AG06466; Drug: Itraconazole

• Registration Number: NCT04405323
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2020-05-20
• Study First Submitted: 2020-05-22
• Study First Submitted QC: 2020-05-22
• Study First Posted: 2020-05-28
• Primary Completion: 2020-07-28
• Study Completion: 2020-07-28
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-13
• Last Update Posted: 2020-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Exclusion Criteria

• The subject is a poor metabolizer (PM) of CYP2C9 and/or CYP2C19.

Other in- and exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Lu AG06466 - Sequence 1	Lu AG06466	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.
Lu AG06466 - Sequence 2	Lu AG06466	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.
Lu AG06466 - Sequence 1	Itraconazole	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.
Lu AG06466 - Sequence 2	Itraconazole	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.

Primary Outcome Measures

Name	Time	Method
AUC(0-inf) Lu AG06466	From 0 to 48 hours post-dose on Day 1, 3, 8 and 10	Area under the Lu AG06466 plasma concentration-time curve from time zero to infinity
Cmax Lu AG06466	From 0 to 48 hours post-dose on Day 1, 3, 8 and 10	Maximum observed plasma concentration (Cmax) of Lu AG06466
Cmax Lu AG06988	From 0 to 48 hours post-dose on Day 1, 3, 8 and 10	Maximum observed plasma concentration (Cmax) of Lu AG06988
AUC(0-inf) Lu AG06988	From 0 to 48 hours post-dose on Day 1, 3, 8 and 10	Area under the Lu AG06988 plasma concentration-time curve from time zero to infinity

Trial Locations

Locations (1)

US1517; 🇺🇸 Miami, Florida, United States