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

H. Lundbeck A/S20 enrolled

Overview

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

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 Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Drug CocktailDRUG

Single oral dose of the cocktail probe substrates (caffeine 200 mg, montelukast 10 mg, midazolam 4 mg)

FoligluraxDRUG

Foliglurax

midazolam ivDRUG

Single intravenous (iv) dose of midazolam 0.025 mg/kg

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * 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

Locations (1)

Biotrial

Rennes, France

Outcomes

Primary Outcomes

AUC0-inf

Area under the plasma concentration-time curve from zero to infinity for midazolam after iv administration and for all oral cocktail probe substrates

Time frame: Day 1 and 11 for midazolam iv and Day 2,12 and 20 for oral cocktail probe substrates

Cmax

Maximum observed plasma concentration of midazolam after iv administration and for all oral cocktail probe substrates

Time frame: Day 1 and 11 for midazolam iv and Day 2,12 and 20 for oral cocktail probe substrates

Data from ClinicalTrials.gov

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