Drug Drug Interaction Study With Lu AG06466 in Young Healthy Men

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Lu AG06466; Other: Midazolam; Other: Metoprolol; Other: Bupropion

• Registration Number: NCT04713254
• Lead Sponsor: H. Lundbeck A/S

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

Detailed Description

On Day 1, midazolam and metoprolol will be dosed as an oral single-dose cocktail and PK sampling will be performed for 48 hours.

On Day 3, bupropion will be dosed as a single oral dose and PK sampling will be performed for 48 hours.

On Days 5-18, subjects will be dosed with Lu AG06466 once daily.

On Day 15, midazolam and metoprolol will be dosed as an oral single-dose cocktail and PK sampling will be performed for 48 hours.

On Day 17, bupropion will be dosed as a single oral dose and PK sampling will be performed for 48 hours.

Study Timeline

• Study Start: 2020-12-08
• Study First Submitted: 2021-01-14
• Study First Submitted QC: 2021-01-14
• Study First Posted: 2021-01-19
• Status Verified: 2021-04
• Primary Completion: 2021-04-09
• Study Completion: 2021-04-09
• Last Update Submitted: 2021-04-19
• Last Update Posted: 2021-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

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

Exclusion Criteria

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

Other in- and exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Lu AG06466	Metoprolol	-
Lu AG06466	Midazolam	-
Lu AG06466	Lu AG06466	-
Lu AG06466	Bupropion	-

Primary Outcome Measures

Name	Time	Method
Cmax for midazolam	Day 1 and Day 15	Maximum observed plasma concentration for midazolam
AUC 0-inf for bupropion	Day 3 and Day 17	Area under the bupropion plasma concentration-time curve from zero to infinity
AUC 0-inf for metoprolol	Day 1 and Day 15	Area under the metoprolol plasma concentration-time curve from zero to infinity
AUC 0-inf for midazolam	Day 1 and Day 15	Area under the midazolam plasma concentration-time curve from zero to infinity
Cmax for metoprolol	Day 1 and Day 15	Maximum observed plasma concentration for metoprolol
Cmax for bupropion	Day 3 and Day 17	Maximum observed plasma concentration for bupropion

Trial Locations

Locations (1)

Covance Dallas CRU; 🇺🇸 Dallas, Texas, United States