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Effects of Repeated Doses of Foliglurax on Drug Metabolizing Enzymes in Healthy Subjects

Healthy Clinical Trial

Official title:
Interventional, Open-label, One-sequence Study to Investigate the Effects of Multiple Doses of Foliglurax on the Pharmacokinetics of Cytochrome P450 (CYP450) Substrates Caffeine (CYP1A2), Montelukast (CYP2C8), and Midazolam (CYP3A4) in Healthy Subjects

Clinical Trial Summary

The purpose of this study is to help determine which types of drugs that may interact with foliglurax

Clinical Trial 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: investigation of the CYP450 probe substrates (caffeine, montelukast, midazolam) alone followed by a 2-day washout before start of Period 2.

- Period 2: administration of foliglurax for 7 days to reach steady state.

- Period 3: administration of the CYP450 probe substrates in combination with foliglurax followed by a 7-day washout before start of Period 4.

- Period 4: investigation of the effects of foliglurax on the PK of the CYP450 probe substrates following washout of foliglurax. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04275115
Study type Interventional
Source H. Lundbeck A/S
Contact
Status Completed
Phase Phase 1
Start date February 10, 2020
Completion date April 3, 2020
View Details
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