Effects of Repeated Doses of Foliglurax on Drug Metaboliz... | NCT04275115

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

NCT04275115

Sponsor

H. Lundbeck A/S

Status

Completed

Last Update Posted

Apr 24, 2020Actual

Enrollment

20Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Drug Cocktail
Foliglurax
midazolam iv

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 10, 2020Actual

Primary Completion Date

Apr 3, 2020Actual

Completion Date

Apr 3, 2020Actual

First Submitted Date

Feb 17, 2020

First Submission Date that Met QC Criteria

Feb 17, 2020

First Posted Date

Feb 19, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2020

Last Update Posted Date

Apr 24, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Foliglurax	Experimental	Foliglurax, iv midazolam and cocktail of CYP450 probe substrates	Drug: Drug Cocktail Drug: Foliglurax Drug: midazolam iv

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Drug Cocktail	Drug	Single oral dose of the cocktail probe substrates (caffeine 200 mg, montelukast 10 mg, midazolam 4 mg)	Foliglurax

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Email contact via H. Lundbeck A/S	LundbeckClinicalTrials@Lundbeck.com	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Biotrial		Rennes		35000	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000730045	foliglurax

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided