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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Lu AG06466; Other: Midazolam; Other: Metoprolol; Other: 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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75247
      • Covance Dallas CRU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2020
• Primary Completion (Actual): April 9, 2021
• Study Completion (Actual): April 9, 2021

Study Registration Dates

• First Submitted: January 14, 2021
• First Submitted That Met QC Criteria: January 14, 2021
• First Posted (Actual): January 19, 2021

Study Record Updates

• Last Update Posted (Actual): April 20, 2021
• Last Update Submitted That Met QC Criteria: April 19, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Dopamine Uptake Inhibitors; Sympatholytics; Adrenergic beta-1 Receptor Antagonists; Midazolam; Bupropion; Metoprolol
• Other Study ID Numbers: 19353A

Drug and device information, study documents

• 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