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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04275115
• Other study ID #: 18337A
• Status: Completed
• Phase: Phase 1
• Start date: February 10, 2020
• Est. completion date: April 3, 2020

Study information

• Verified date: April 2020
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 3, 2020
• Est. primary completion date: April 3, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Drug Cocktail
Single oral dose of the cocktail probe substrates (caffeine 200 mg, montelukast 10 mg, midazolam 4 mg)
• Foliglurax
Foliglurax
• midazolam iv
Single intravenous (iv) dose of midazolam 0.025 mg/kg

Locations

Country	Name	City	State
France	Biotrial	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 1 and 11 for midazolam iv and Day 2,12 and 20 for oral cocktail probe substrates
Primary	Cmax	Maximum observed plasma concentration of midazolam after iv administration and for all oral cocktail probe substrates	Day 1 and 11 for midazolam iv and Day 2,12 and 20 for oral cocktail probe substrates