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Completed

NCT Number: NCT04713254

Drug Drug Interaction Study With Lu AG06466 in Young Healthy Men

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

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Dallas CRU

Dallas, Texas, 75247, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lu AG06466

Drug

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

Midazolam

Other

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

Metoprolol

Other

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

Bupropion

Other

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

Primary outcomes

  1. AUC 0-inf for midazolam

    Time frame: Day 1 and Day 15

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

  2. AUC 0-inf for metoprolol

    Time frame: Day 1 and Day 15

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

  3. AUC 0-inf for bupropion

    Time frame: Day 3 and Day 17

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

  4. Cmax for midazolam

    Time frame: Day 1 and Day 15

    Maximum observed plasma concentration for midazolam

  5. Cmax for metoprolol

    Time frame: Day 1 and Day 15

    Maximum observed plasma concentration for metoprolol

  6. Cmax for bupropion

    Time frame: Day 3 and Day 17

    Maximum observed plasma concentration for bupropion

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 19, 2021
Registry last updated
Apr 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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