Drug Drug Interaction Study With Lu AG06466 in Young Healthy Men

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04713254
• Other study ID #: 19353A
• Status: Completed
• Phase: Phase 1
• Start date: December 8, 2020
• Est. completion date: April 9, 2021

Study information

• Verified date: April 2021
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 9, 2021
• Est. primary completion date: April 9, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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
• Metoprolol
100 mg tablets, oral single dose on Day 1 and Day 15
• Bupropion
100 mg tablets, oral single dose on Day 3 and Day 17

Locations

Country	Name	City	State
United States	Covance Dallas CRU	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC 0-inf for midazolam	Area under the midazolam plasma concentration-time curve from zero to infinity	Day 1 and Day 15
Primary	AUC 0-inf for metoprolol	Area under the metoprolol plasma concentration-time curve from zero to infinity	Day 1 and Day 15
Primary	AUC 0-inf for bupropion	Area under the bupropion plasma concentration-time curve from zero to infinity	Day 3 and Day 17
Primary	Cmax for midazolam	Maximum observed plasma concentration for midazolam	Day 1 and Day 15
Primary	Cmax for metoprolol	Maximum observed plasma concentration for metoprolol	Day 1 and Day 15
Primary	Cmax for bupropion	Maximum observed plasma concentration for bupropion	Day 3 and Day 17