Drug Drug Interaction Study With Lu AG06466 in Young Healthy Men

• Sponsor: H. Lundbeck A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04713254
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Actual Duration (Months): 4
• Patients Per Site Per Month: 3.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Lu AG06466; Other: Midazolam; Other: Metoprolol; Other: Bupropion	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Dec 8, 2020
• Actual Primary Completion Date: Apr 9, 2021
• Actual Study Completion Date: Apr 9, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lu AG06466	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

Outcome Measures

Primary Outcome Measures

1. AUC 0-inf for midazolam [Day 1 and Day 15]

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

2. AUC 0-inf for metoprolol [Day 1 and Day 15]

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

3. AUC 0-inf for bupropion [Day 3 and Day 17]

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

4. Cmax for midazolam [Day 1 and Day 15]

   Maximum observed plasma concentration for midazolam

5. Cmax for metoprolol [Day 1 and Day 15]

   Maximum observed plasma concentration for metoprolol

6. Cmax for bupropion [Day 3 and Day 17]

   Maximum observed plasma concentration for bupropion

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Covance Dallas CRU	Dallas	Texas	United States	75247

Sponsors and Collaborators

• H. Lundbeck A/S

Investigators

• Study Director: Email contact via H. Lundbeck A/S, [e-mail]

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: H. Lundbeck A/S
• ClinicalTrials.gov Identifier: NCT04713254
• Other Study ID Numbers: 19353A
• First Posted: Jan 19, 2021
• Last Update Posted: Apr 20, 2021
• Last Verified: Apr 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Metoprolol; Midazolam; Bupropion

Study Results

No Results Posted as of Apr 20, 2021