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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04275115

Enrollment

Registered

2020-02-19

Start date

2020-02-10

Completion date

2020-04-03

Last updated

2020-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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: 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.

Interventions

DRUGDrug Cocktail

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

DRUGFoliglurax

Foliglurax

DRUGmidazolam iv

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

Study design

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
AUC0-inf	Day 1 and 11 for midazolam iv and Day 2,12 and 20 for oral cocktail probe substrates	Area under the plasma concentration-time curve from zero to infinity for midazolam after iv administration and for all oral cocktail probe substrates
Cmax	Day 1 and 11 for midazolam iv and Day 2,12 and 20 for oral cocktail probe substrates	Maximum observed plasma concentration of midazolam after iv administration and for all oral cocktail probe substrates

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026