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

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT04405323

Run by

H. Lundbeck A/S

People needed

16

Starts

2020-05-20

Expected to finish

2020-07-28

Last updated by the study team

2020-08-14

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• The subject is a poor metabolizer (PM) of CYP2C9 and/or CYP2C19.
• Other in- and exclusion criteria may apply

Where it is running

• US1517 — Miami, Florida, United States

Full record on ClinicalTrials.gov

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