HealthyPhase 1NCT04713254
Drug Drug Interaction Study With Lu AG06466 in Young Healthy Men
A Phase 1 study testing Lu AG06466, Midazolam and Metoprolol in people with Healthy, run by H. Lundbeck A/S at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lu AG06466, Midazolam and Metoprolol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2020to 9 Apr 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) of 18.5 to 30 kg/m2 (inclusive) at the Screening and Baseline Visits
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AG06466Drug
10, 20, 30 mg/day oral capsules on Day 5-18
MidazolamOther
4 mg syrup, oral single dose on Day 1 and Day 15
MetoprololOther
100 mg tablets, oral single dose on Day 1 and Day 15
BupropionOther
100 mg tablets, oral single dose on Day 3 and Day 17
| Study group | Role | What they receive |
|---|---|---|
| Lu AG06466 | Experimental | Not described Receives: Drug: Lu AG06466; Other: Midazolam; Other: Metoprolol; Other: Bupropion |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC 0-inf for midazolam
Area under the midazolam plasma concentration-time curve from zero to infinity
Measured: Day 1 and Day 15
AUC 0-inf for metoprolol
Area under the metoprolol plasma concentration-time curve from zero to infinity
Measured: Day 1 and Day 15
AUC 0-inf for bupropion
Area under the bupropion plasma concentration-time curve from zero to infinity
Measured: Day 3 and Day 17
Cmax for midazolam
Maximum observed plasma concentration for midazolam
Measured: Day 1 and Day 15
Cmax for metoprolol
Maximum observed plasma concentration for metoprolol
Measured: Day 1 and Day 15
Cmax for bupropion
Maximum observed plasma concentration for bupropion
Measured: Day 3 and Day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start8 Dec 2020
- Primary completion9 Apr 2021
- Study completion9 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@Lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713254
- Sponsor's protocol ID
- 19353A
- Status last verified
- Apr 2021
- First submitted
- 14 Jan 2021
- Last updated
- 20 Apr 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04713254
- Acronym / sponsor ID
- 19353A
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 9 Apr 2021 (actual)
- Study completion
- 9 Apr 2021 (actual)
- First posted
- 19 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lu AG06466 | Experimental | Drug: Lu AG06466, Other: Midazolam, Other: Metoprolol, Other: Bupropion |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body mass index (BMI) of 18.5 to 30 kg/m2 (inclusive) at the Screening and Baseline Visits
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lu AG0646610, 20, 30 mg/day oral capsules on Day 5-18 | Drug | Lu AG06466 |
| Midazolam4 mg syrup, oral single dose on Day 1 and Day 15 | Other | Lu AG06466 |
| Metoprolol100 mg tablets, oral single dose on Day 1 and Day 15 | Other | Lu AG06466 |
| Bupropion100 mg tablets, oral single dose on Day 3 and Day 17 | Other | Lu AG06466 |
Primary outcome
AUC 0-inf for midazolam
Time frame: Day 1 and Day 15
Area under the midazolam plasma concentration-time curve from zero to infinity
AUC 0-inf for metoprolol
Time frame: Day 1 and Day 15
Area under the metoprolol plasma concentration-time curve from zero to infinity
AUC 0-inf for bupropion
Time frame: Day 3 and Day 17
Area under the bupropion plasma concentration-time curve from zero to infinity
Cmax for midazolam
Time frame: Day 1 and Day 15
Maximum observed plasma concentration for midazolam
Cmax for metoprolol
Time frame: Day 1 and Day 15
Maximum observed plasma concentration for metoprolol
Cmax for bupropion
Time frame: Day 3 and Day 17
Maximum observed plasma concentration for bupropion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Email contact via H. Lundbeck A/S study director
LundbeckClinicalTrials@Lundbeck.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lu AG06466, Midazolam and Metoprolol in people with Healthy, run by H. Lundbeck A/S at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC 0-inf for midazolam (time frame: Day 1 and Day 15). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2021.