Drug Drug Interaction Study With Lu AG06466 in Young Healthy Men

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Other: Midazolam; Other: Bupropion; Drug: Lu AG06466; Other: Metoprolol

Study type: Interventional

Funder types: Industry

Identifiers

NCT04713254

19353A

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Lu AG06466

Experimental group

Treatment:

Other: Metoprolol

Other: Midazolam

Drug: Lu AG06466

Other: Bupropion