NCT04713254

Brief Summary

The purpose of this study is to evaluate the effect of repeated doses of the drug Lu AG06466 on the exposure of metoprolol, midazolam and bupropion

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Dec 2020

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

December 8, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 14, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 19, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2021

Completed
Last Updated

April 20, 2021

Status Verified

April 1, 2021

Enrollment Period

4 months

First QC Date

January 14, 2021

Last Update Submit

April 19, 2021

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

  • AUC 0-inf for midazolam

    Area under the midazolam plasma concentration-time curve from zero to infinity

    Day 1 and Day 15

  • AUC 0-inf for metoprolol

    Area under the metoprolol plasma concentration-time curve from zero to infinity

    Day 1 and Day 15

  • AUC 0-inf for bupropion

    Area under the bupropion plasma concentration-time curve from zero to infinity

    Day 3 and Day 17

  • Cmax for midazolam

    Maximum observed plasma concentration for midazolam

    Day 1 and Day 15

  • Cmax for metoprolol

    Maximum observed plasma concentration for metoprolol

    Day 1 and Day 15

  • Cmax for bupropion

    Maximum observed plasma concentration for bupropion

    Day 3 and Day 17

Study Arms (1)

Lu AG06466

EXPERIMENTAL
Drug: Lu AG06466Other: MidazolamOther: MetoprololOther: Bupropion

Interventions

Lu AG06466DRUG

10, 20, 30 mg/day oral capsules on Day 5-18

Lu AG06466
MidazolamOTHER

4 mg syrup, oral single dose on Day 1 and Day 15

Lu AG06466
MetoprololOTHER

100 mg tablets, oral single dose on Day 1 and Day 15

Lu AG06466
BupropionOTHER

100 mg tablets, oral single dose on Day 3 and Day 17

Lu AG06466

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index (BMI) of 18.5 to 30 kg/m2 (inclusive) at the Screening and Baseline Visits

You may not qualify if:

  • The subject has any concurrent disorder that may affect the pharmacological target or absorption, distribution, or elimination of the investigational medicinal product.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance Dallas CRU

Dallas, Texas, 75247, United States

Location

MeSH Terms

Interventions

MidazolamMetoprololBupropion

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesPropiophenonesKetones

Study Officials

  • Email contact via H. Lundbeck A/S

    LundbeckClinicalTrials@Lundbeck.com

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

January 14, 2021

First Posted

January 19, 2021

Study Start

December 8, 2020

Primary Completion

April 9, 2021

Study Completion

April 9, 2021

Last Updated

April 20, 2021

Record last verified: 2021-04

Locations

US(1)