HealthyPhase 1NCT04405323
Study That Evaluates the Effect of CYP3A4 Inhibition on Lu AG06466 in Healthy Men and Women
A Phase 1 study testing Lu AG06466 and Itraconazole in people with Healthy, run by H. Lundbeck A/S at 1 site in United States.
Trial summary
A study to learn how a drug (itraconazole) that is known to inhibit a certain enzym in the liver, impacts the body's ability to breakdown Lu AG06466 into breakdown products in healthy men and women. The main breakdown product is Lu AG06988. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lu AG06466 and Itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2020to 28 Jul 2020
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject has a BMI ≥18.5 and ≤30 kg/m2
- The subject is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, a neurological examination, vital signs, an electrocardiogram (ECG), and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.
- The subject must not be of childbearing potential (if a woman) or should use contraception (both sexes). If women, the subject must not be pregnant or breastfeeding.
Who cannot join
- The subject is a poor metabolizer (PM) of CYP2C9 and/or CYP2C19.
- Other in- and exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventional, Open-label, Randomized, Two-sequence Study Evaluating the Effect of CYP3A4 Inhibition on the Pharmacokinetics, Safety and Tolerability of Lu AG06466 in Healthy Men and Women
A study to learn how a drug (itraconazole) that is known to inhibit a certain enzym in the liver, impacts the body's ability to breakdown Lu AG06466 into breakdown products in healthy men and women. The main breakdown product is Lu AG06988.
Read the detailed description
Two sequence study where Lu AG06466 will be dosed with and without food, Sequence 1 and Sequence 2. Each subject will receive single oral doses of Lu AG06466. Subject will be randomized to one of two sequences.
For inhibition of CYP3A4, each subject will receive a once daily dosage of itraconazole from Day 5 to Day 11.
- Conditions
- Healthy
- Being tested
- Lu AG06466, Itraconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AG06466Drug
hard capsules, orally, single doses
ItraconazoleDrug
200 and 300 mg, capsules, orally
| Study group | Role | What they receive |
|---|---|---|
| Lu AG06466 - Sequence 1 | Experimental | Dosing on Days 1 and 8 will be following an overnight fast, and dosing on Days 3 and 10 will be following a standard high-fat breakfast. Receives: Drug: Lu AG06466; Drug: Itraconazole |
| Lu AG06466 - Sequence 2 | Experimental | Dosing on Days 1 and 8 will be following, a standard high-fat breakfast and dosing on Days 3 and 10 will be following an overnight fast. Receives: Drug: Lu AG06466; Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC(0-inf) Lu AG06466
Area under the Lu AG06466 plasma concentration-time curve from time zero to infinity
Measured: From 0 to 48 hours post-dose on Day 1, 3, 8 and 10
AUC(0-inf) Lu AG06988
Area under the Lu AG06988 plasma concentration-time curve from time zero to infinity
Measured: From 0 to 48 hours post-dose on Day 1, 3, 8 and 10
Cmax Lu AG06466
Maximum observed plasma concentration (Cmax) of Lu AG06466
Measured: From 0 to 48 hours post-dose on Day 1, 3, 8 and 10
Cmax Lu AG06988
Maximum observed plasma concentration (Cmax) of Lu AG06988
Measured: From 0 to 48 hours post-dose on Day 1, 3, 8 and 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start20 May 2020
- Primary completion28 Jul 2020
- Study completion28 Jul 2020
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
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT04405323
- Sponsor's protocol ID
- 18453A
- Status last verified
- Aug 2020
- First submitted
- 22 May 2020
- Last updated
- 14 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Open-label, Randomized, Two-sequence Study Evaluating the Effect of CYP3A4 Inhibition on the Pharmacokinetics, Safety and Tolerability of Lu AG06466 in Healthy Men and Women
- ClinicalTrials.gov ID
- NCT04405323
- Acronym / sponsor ID
- 18453A
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 20 May 2020 (actual)
- Primary completion
- 28 Jul 2020 (actual)
- Study completion
- 28 Jul 2020 (actual)
- First posted
- 28 May 2020 (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.
A study to learn how a drug (itraconazole) that is known to inhibit a certain enzym in the liver, impacts the body's ability to breakdown Lu AG06466 into breakdown products in healthy men and women. The main breakdown product is Lu AG06988.
Detailed description
Two sequence study where Lu AG06466 will be dosed with and without food, Sequence 1 and Sequence 2. Each subject will receive single oral doses of Lu AG06466. Subject will be randomized to one of two sequences.
For inhibition of CYP3A4, each subject will receive a once daily dosage of itraconazole from Day 5 to Day 11.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lu AG06466 - Sequence 1 | Experimental | Drug: Lu AG06466, Drug: ItraconazoleDosing on Days 1 and 8 will be following an overnight fast, and dosing on Days 3 and 10 will be following a standard high-fat breakfast. |
| Lu AG06466 - Sequence 2 | Experimental | Drug: Lu AG06466, Drug: ItraconazoleDosing on Days 1 and 8 will be following, a standard high-fat breakfast and dosing on Days 3 and 10 will be following an overnight fast. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- The subject has a BMI ≥18.5 and ≤30 kg/m2
- The subject is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, a neurological examination, vital signs, an electrocardiogram (ECG), and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.
- The subject must not be of childbearing potential (if a woman) or should use contraception (both sexes). If women, the subject must not be pregnant or breastfeeding.
Key exclusion criteria (2 listed)
- The subject is a poor metabolizer (PM) of CYP2C9 and/or CYP2C19.
- 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 AG06466hard capsules, orally, single doses | Drug | Lu AG06466 - Sequence 1, Lu AG06466 - Sequence 2 |
| Itraconazole200 and 300 mg, capsules, orally | Drug | Lu AG06466 - Sequence 1, Lu AG06466 - Sequence 2 |
Primary outcome
AUC(0-inf) Lu AG06466
Time frame: From 0 to 48 hours post-dose on Day 1, 3, 8 and 10
Area under the Lu AG06466 plasma concentration-time curve from time zero to infinity
AUC(0-inf) Lu AG06988
Time frame: From 0 to 48 hours post-dose on Day 1, 3, 8 and 10
Area under the Lu AG06988 plasma concentration-time curve from time zero to infinity
Cmax Lu AG06466
Time frame: From 0 to 48 hours post-dose on Day 1, 3, 8 and 10
Maximum observed plasma concentration (Cmax) of Lu AG06466
Cmax Lu AG06988
Time frame: From 0 to 48 hours post-dose on Day 1, 3, 8 and 10
Maximum observed plasma concentration (Cmax) of Lu AG06988
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 14 Aug 2020.
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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 and Itraconazole 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 3 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 14 Aug 2020. 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) Lu AG06466 (time frame: From 0 to 48 hours post-dose on Day 1, 3, 8 and 10). The study lists 4 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 14 Aug 2020.