NCT04713254

Drug Drug Interaction Study With Lu AG06466 in Young Healthy Men

Interventional, Open-label, One-sequence Study to Investigate the Effects of Lu AG06466 on the Pharmacokinetics of the Cytochrome P450 Substrates Midazolam (CYP3A4), Bupropion (CYP2B6), and Metoprolol (CYP2D6) in Healthy Young Men and Women

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Lu AG06466	10, 20, 30 mg/day oral capsules on Day 5-18
OTHER	Midazolam	4 mg syrup, oral single dose on Day 1 and Day 15
OTHER	Metoprolol	100 mg tablets, oral single dose on Day 1 and Day 15
OTHER	Bupropion	100 mg tablets, oral single dose on Day 3 and Day 17

Timeline

• Start date: 2020-12-08
• Primary completion: 2021-04-09
• Completion: 2021-04-09
• First posted: 2021-01-19
• Last updated: 2021-04-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study