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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
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04713254
Enrollment
15
Registered
2021-01-19
Start date
2020-12-08
Completion date
2021-04-09
Last updated
2021-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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

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.

Interventions

DRUGLu AG06466

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

OTHERMidazolam

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

OTHERMetoprolol

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

OTHERBupropion

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

Sponsors

H. Lundbeck A/S
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
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

Design outcomes

Primary

MeasureTime frameDescription
AUC 0-inf for midazolamDay 1 and Day 15Area under the midazolam plasma concentration-time curve from zero to infinity
AUC 0-inf for metoprololDay 1 and Day 15Area under the metoprolol plasma concentration-time curve from zero to infinity
AUC 0-inf for bupropionDay 3 and Day 17Area under the bupropion plasma concentration-time curve from zero to infinity
Cmax for midazolamDay 1 and Day 15Maximum observed plasma concentration for midazolam
Cmax for metoprololDay 1 and Day 15Maximum observed plasma concentration for metoprolol
Cmax for bupropionDay 3 and Day 17Maximum observed plasma concentration for bupropion

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026