NCT04275115

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Feb 2020

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 19, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2020

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

2 months

First QC Date

February 17, 2020

Last Update Submit

April 22, 2020

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

Foliglurax

EXPERIMENTAL

Foliglurax, iv midazolam and cocktail of CYP450 probe substrates

Drug: Drug CocktailDrug: FoligluraxDrug: midazolam iv

Interventions

Drug CocktailDRUG

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

Foliglurax
FoligluraxDRUG

Foliglurax

Foliglurax
midazolam ivDRUG

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

Foliglurax

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biotrial

Rennes, 35000, France

Location

MeSH Terms

Interventions

foliglurax

Study Officials

  • Email contact via H. Lundbeck A/S

    LundbeckClinicalTrials@Lundbeck.com

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2020

First Posted

February 19, 2020

Study Start

February 10, 2020

Primary Completion

April 3, 2020

Study Completion

April 3, 2020

Last Updated

April 24, 2020

Record last verified: 2020-04

Locations

FR(1)