Status:
COMPLETED
Study That Evaluates the Effect of CYP3A4 Inhibition on Lu AG06466 in Healthy Men and Women
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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. T...
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 ...
Eligibility Criteria
Inclusion
- 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
- The subject is a poor metabolizer (PM) of CYP2C9 and/or CYP2C19.
- Other in- and exclusion criteria may apply
Key Trial Info
Start Date :
May 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 28 2020
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04405323
Start Date
May 20 2020
End Date
July 28 2020
Last Update
August 14 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
US1517
Miami, Florida, United States, 33126