Status:
COMPLETED
Effects of Repeated Doses of Foliglurax on Drug Metabolizing Enzymes in Healthy Subjects
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to help determine which types of drugs that may interact with foliglurax
Detailed Description
This study is designed to evaluate the PK of caffeine, montelukast and midazolam following multiple doses of foliglurax in healthy subjects. The study is divided into four periods: * Period 1: invest...
Eligibility Criteria
Inclusion
- Healthy men and women with a body mass index (BMI) of ≥ 18.5 and ≤ 30 kg/m2 and a minimum body weight of 60 kg for men and 50 kg for women.
- Women of child-bearing potential will have a confirmed non-pregnant and non-lactating status.
Exclusion
- The subject has a regular intake of more than 500 mg of caffeine per day or impossibility to stop intake, on holidays for example, without headaches forcing to take caffeine again.
- Other in- and exclusion criteria may apply
Key Trial Info
Start Date :
February 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 3 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04275115
Start Date
February 10 2020
End Date
April 3 2020
Last Update
April 24 2020
Active Locations (1)
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1
Biotrial
Rennes, France, 35000