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

Lundbeck

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Drug Cocktail

Drug: midazolam iv

Drug: Foliglurax

Study type

Interventional

Funder types

Industry

Identifiers

NCT04275115

18337A

Details and patient eligibility

About

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

Full 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.

Enrollment

20 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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