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

• Sponsor: H. Lundbeck A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04405323
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.3
• Patients Per Site Per Month: 7.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Lu AG06466; Drug: Itraconazole	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: May 20, 2020
• Actual Primary Completion Date: Jul 28, 2020
• Actual Study Completion Date: Jul 28, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. 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

4. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	US1517	Miami	Florida	United States	33126

Sponsors and Collaborators

• H. Lundbeck A/S

Investigators

• Study Director: Email contact via H. Lundbeck A/S, [e-mail]

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: H. Lundbeck A/S
• ClinicalTrials.gov Identifier: NCT04405323
• Other Study ID Numbers: 18453A
• First Posted: May 28, 2020
• Last Update Posted: Aug 14, 2020
• Last Verified: Aug 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Itraconazole

Study Results

No Results Posted as of Aug 14, 2020