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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Drug Cocktail; Drug: Foliglurax; Drug: midazolam iv

• Registration Number: NCT04275115
• Lead Sponsor: H. Lundbeck A/S

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.

Study Timeline

• Study Start: 2020-02-10
• Study First Submitted: 2020-02-17
• Study First Submitted QC: 2020-02-17
• Study First Posted: 2020-02-19
• Status Verified: 2020-04
• Primary Completion: 2020-04-03
• Study Completion: 2020-04-03
• Last Update Submitted: 2020-04-22
• Last Update Posted: 2020-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Foliglurax	midazolam iv	Foliglurax, iv midazolam and cocktail of CYP450 probe substrates
Foliglurax	Drug Cocktail	Foliglurax, iv midazolam and cocktail of CYP450 probe substrates
Foliglurax	Foliglurax	Foliglurax, iv midazolam and cocktail of CYP450 probe substrates

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Biotrial; 🇫🇷 Rennes, France