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Completed

NCT Number: NCT04275115

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

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

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Biotrial

Rennes, 35000, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drug Cocktail

Drug

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

Foliglurax

Drug

Foliglurax

midazolam iv

Drug

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

Primary outcomes

  1. AUC0-inf

    Time frame: 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

  2. Cmax

    Time frame: 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

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 19, 2020
Registry last updated
Apr 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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