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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04405323
• Other study ID #: 18453A
• Status: Completed
• Phase: Phase 1
• Start date: May 20, 2020
• Est. completion date: July 28, 2020

Study information

• Verified date: August 2020
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 28, 2020
• Est. primary completion date: July 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Lu AG06466
hard capsules, orally, single doses
• Itraconazole
200 and 300 mg, capsules, orally

Locations

Country	Name	City	State
United States	US1517	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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