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

Interventional, Open-label, Randomized, Two-sequence Study Evaluating the Effect of CYP3A4 Inhibition on the Pharmacokinetics, Safety and Tolerability of Lu AG06466 in Healthy Men and Women

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Lu AG06466; Drug: Itraconazole

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33126
      • US1517

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Lu AG06466; hard capsules, orally, single doses; Drug: Itraconazole; 200 and 300 mg, capsules, orally
Experimental: 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.	Drug: Lu AG06466; hard capsules, orally, single doses; Drug: Itraconazole; 200 and 300 mg, capsules, orally

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2020
• Primary Completion (Actual): July 28, 2020
• Study Completion (Actual): July 28, 2020

Study Registration Dates

• First Submitted: May 22, 2020
• First Submitted That Met QC Criteria: May 22, 2020
• First Posted (Actual): May 28, 2020

Study Record Updates

• Last Update Posted (Actual): August 14, 2020
• Last Update Submitted That Met QC Criteria: August 13, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Itraconazole
• Other Study ID Numbers: 18453A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No