NCT04275115

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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: 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Drug Cocktail	Single oral dose of the cocktail probe substrates (caffeine 200 mg, montelukast 10 mg, midazolam 4 mg)
DRUG	Foliglurax	Foliglurax
DRUG	midazolam iv	Single intravenous (iv) dose of midazolam 0.025 mg/kg

Timeline

• Start date: 2020-02-10
• Primary completion: 2020-04-03
• Completion: 2020-04-03
• First posted: 2020-02-19
• Last updated: 2020-04-24

Locations

1 site across 1 country: France