Dallas, Texas 75247

  • Healthy

Purpose:

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 summary:

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.


Criteria:

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 is Available At:


Original ID:

19353A


NCT ID:

NCT04713254


Secondary ID:


Study Acronym:


Brief Title:

Drug Drug Interaction Study With Lu AG06466 in Young Healthy Men


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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

45 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

H. Lundbeck A/S


Oversight Authority:

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Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

15


Enrollment Type:

Actual


Overall Contact Information

Official Name:Email contact via H. Lundbeck A/S
Study Director
LundbeckClinicalTrials@Lundbeck.com

Study Dates

Start Date:December 8, 2020
Completion Date:April 9, 2021
Completion Type:Actual
Primary Completion Date:April 9, 2021
Primary Completion Type:Actual
Verification Date:April 2021
Last Changed Date:April 19, 2021
First Received Date:January 14, 2021

Study Outcomes

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

Study Interventions

Intervention Type:Other
Name:Bupropion
Description:100 mg tablets, oral single dose on Day 3 and Day 17
Arm Name:Lu AG06466
Intervention Type:Other
Name:Metoprolol
Description:100 mg tablets, oral single dose on Day 1 and Day 15
Arm Name:Lu AG06466
Intervention Type:Other
Name:Midazolam
Description:4 mg syrup, oral single dose on Day 1 and Day 15
Arm Name:Lu AG06466
Intervention Type:Drug
Name:Lu AG06466
Description:10, 20, 30 mg/day oral capsules on Day 5-18
Arm Name:Lu AG06466

Study Arms

Study Arm Type:Experimental
Arm Name:Lu AG06466

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:H. Lundbeck A/S

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 27, 2021

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