HealthyPhase 1NCT05028673
A Study to Evaluate a New Tablet Formulation of Lu AG06466 in Healthy Participants
A Phase 1 study testing Lu AG06466 Capsule, Lu AG06466 Tablet and Antacid in people with Healthy, run by H. Lundbeck A/S at 1 site in United Kingdom.
Trial summary
The main goal of this trial is to learn how a new tablet formulation of Lu AG06466 behaves in the body. Researchers will compare the new tablet formulation to the capsule formulation that is currently being tested in other clinical trials. 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 Capsule, Lu AG06466 Tablet and Antacid
- 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 Kingdom
- Study dates
- 23 Aug 2021to 29 Dec 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The participant has a body mass index (BMI) ≥18.5 and ≤30 kg/m^2 at the Screening Visit and at the Baseline Visit.
- The participant is, in the opinion of the investigator, generally healthy based on medical history; a physical examination; vital signs; an electrocardiogram (ECG); and the results of the clinical chemistry, hematology, urinalysis, serology, and other laboratory tests at the Screening Visit and/or the Baseline Visit.
Who cannot join
- The participant has a personal history of a clinically significant psychiatric disorder (including severe affective disorder, severe anxiety disorder, psychotic tendencies, and drug-induced psychoses).
- The participant has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, hematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder.
- Other inclusion and exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventional, Randomized, Open-Label, Crossover, Single-Dose, Relative Bioavailability Study Comparing Two Pharmaceutical Formulations of Lu AG06466 and Investigating the Food Effect on Lu AG06466 in Healthy Subjects
The main goal of this trial is to learn how a new tablet formulation of Lu AG06466 behaves in the body. Researchers will compare the new tablet formulation to the capsule formulation that is currently being tested in other clinical trials. They will measure the levels of the drug in the bloodstream for up to 3 days after participants take either the tablet or the capsule formulation. They will also look at whether the tablet formulation behaves differently when it is taken with and without food.
Read the detailed description
This study will consist of 6 sequences with 4 periods (3 days/period) in each sequence. The first 3 periods will be randomized. Each Lu AG06466 dose administration will be separated by a washout period of at least 72 hours.
- Conditions
- Healthy
- Being tested
- Lu AG06466 Capsule, Lu AG06466 Tablet, Antacid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AG06466 CapsuleDrug
Hard capsule
Lu AG06466 TabletDrug
Film-coated tablet
AntacidDrug
Also called Maalox, Aluminum hydroxide and magnesium hydroxide
Oral suspension
| Study group | Role | What they receive |
|---|---|---|
| Lu AG06466 Capsule, Fasted State | Experimental | Participants will receive 1 capsule of Lu AG06466 in a fasted state. Receives: Drug: Lu AG06466 Capsule |
| Lu AG06466 Tablet, Fasted State | Experimental | Participants will receive 1 tablet of Lu AG06466 in a fasted state. Receives: Drug: Lu AG06466 Tablet |
| Lu AG06466 Tablet, Fed State | Experimental | Participants will receive 1 tablet of Lu AG06466 in a fed state (high-fat meal). Receives: Drug: Lu AG06466 Tablet |
| Lu AG06466 Tablet + Antacid, Fasted State | Experimental | Participants will receive 1 tablet of Lu AG06466 dosed in combination with antacid in a fasted state. Receives: Drug: Lu AG06466 Tablet; Drug: Antacid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity AUC(0-inf) of Lu AG06466
AUC(0-inf) is defined as AUC0-tlast + Clast * t1/2 / ln2 (where Clast is the last quantifiable concentration and t1/2 is the apparent elimination half-life).
Measured: 0 (predose) up to 72 hours postdose on Day 1 to Day 12
AUC(0-inf) of Metabolite Lu AG06988
AUC(0-inf) is defined as AUC0-tlast + Clast * t1/2 / ln2 (where Clast is the last quantifiable concentration and t1/2 is the apparent elimination half-life).
Measured: 0 (predose) up to 72 hours postdose on Day 1 to Day 12
Area Under Plasma Concentration-Time Curve from Zero to Last Quantifiable Concentration (AUC0-tlast) of Lu AG06466
Measured: 0 (predose) up to 72 hours postdose on Day 1 to Day 12
AUC0-tlast of Metabolite Lu AG06988
Measured: 0 (predose) up to 72 hours postdose on Day 1 to Day 12
Maximum Observed Plasma Concentration (Cmax) of Lu AG06466
Measured: 0 (predose) up to 72 hours postdose on Day 1 to Day 12
Cmax of Metabolite Lu AG06988
Measured: 0 (predose) up to 72 hours postdose on Day 1 to Day 12
Time to Reach Cmax (Tmax) of Lu AG06466
Measured: 0 (predose) up to 72 hours postdose on Day 1 to Day 12
Tmax of Metabolite Lu AG06988
Measured: 0 (predose) up to 72 hours postdose on Day 1 to Day 12
Apparent Oral Clearance (CL/F) of Lu AG06466
CL/F is defined as dose / AUC0-inf.
Measured: 0 (predose) up to 72 hours postdose on Day 1 to Day 12
Apparent Volume of Distribution (Vz/F) of Lu AG06466
Vz/F is defined as CL/F * t1/2 / ln2.
Measured: 0 (predose) up to 72 hours postdose on Day 1 to Day 12
Apparent Elimination Half-life (t1/2) of Lu AG06466
Measured: 0 (predose) up to 72 hours postdose on Day 1 to Day 12
t1/2 of Metabolite Lu AG06988
Measured: 0 (predose) up to 72 hours postdose on Day 1 to Day 12
Metabolic Ratio (MR)
MR is defined as AUC0-inf, Lu AG06988 / AUC0-inf, Lu AG06466.
Measured: 0 (predose) up to 72 hours postdose on Day 1 to Day 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start23 Aug 2021
- Primary completion29 Dec 2021
- Study completion29 Dec 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
- Randomised
- Intervention model
- Crossover
- Model description
- The first 3 periods will be randomized.
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05028673
- Sponsor's protocol ID
- 19270A
- Status last verified
- Jan 2022
- First submitted
- 25 Aug 2021
- Last updated
- 21 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Randomized, Open-Label, Crossover, Single-Dose, Relative Bioavailability Study Comparing Two Pharmaceutical Formulations of Lu AG06466 and Investigating the Food Effect on Lu AG06466 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05028673
- Acronym / sponsor ID
- 19270A
- 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
- 23 Aug 2021 (actual)
- Primary completion
- 29 Dec 2021 (actual)
- Study completion
- 29 Dec 2021 (actual)
- First posted
- 31 Aug 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 main goal of this trial is to learn how a new tablet formulation of Lu AG06466 behaves in the body. Researchers will compare the new tablet formulation to the capsule formulation that is currently being tested in other clinical trials. They will measure the levels of the drug in the bloodstream for up to 3 days after participants take either the tablet or the capsule formulation. They will also look at whether the tablet formulation behaves differently when it is taken with and without food.
Detailed description
This study will consist of 6 sequences with 4 periods (3 days/period) in each sequence. The first 3 periods will be randomized. Each Lu AG06466 dose administration will be separated by a washout period of at least 72 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The first 3 periods will be randomized.
| Arm | Type | Receives |
|---|---|---|
| Lu AG06466 Capsule, Fasted State | Experimental | Drug: Lu AG06466 CapsuleParticipants will receive 1 capsule of Lu AG06466 in a fasted state. |
| Lu AG06466 Tablet, Fasted State | Experimental | Drug: Lu AG06466 TabletParticipants will receive 1 tablet of Lu AG06466 in a fasted state. |
| Lu AG06466 Tablet, Fed State | Experimental | Drug: Lu AG06466 TabletParticipants will receive 1 tablet of Lu AG06466 in a fed state (high-fat meal). |
| Lu AG06466 Tablet + Antacid, Fasted State | Experimental | Drug: Lu AG06466 Tablet, Drug: AntacidParticipants will receive 1 tablet of Lu AG06466 dosed in combination with antacid in a fasted state. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- The participant has a body mass index (BMI) ≥18.5 and ≤30 kg/m^2 at the Screening Visit and at the Baseline Visit.
- The participant is, in the opinion of the investigator, generally healthy based on medical history; a physical examination; vital signs; an electrocardiogram (ECG); and the results of the clinical chemistry, hematology, urinalysis, serology, and other laboratory tests at the Screening Visit and/or the Baseline Visit.
Key exclusion criteria (3 listed)
- The participant has a personal history of a clinically significant psychiatric disorder (including severe affective disorder, severe anxiety disorder, psychotic tendencies, and drug-induced psychoses).
- The participant has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, hematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder.
- Other inclusion 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 AG06466 CapsuleHard capsule | Drug | Lu AG06466 Capsule, Fasted State |
| Lu AG06466 TabletFilm-coated tablet | Drug | Lu AG06466 Tablet + Antacid, Fasted State, Lu AG06466 Tablet, Fasted State, Lu AG06466 Tablet, Fed State |
| AntacidAlso: Maalox, Aluminum hydroxide and magnesium hydroxideOral suspension | Drug | Lu AG06466 Tablet + Antacid, Fasted State |
Primary outcome
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity AUC(0-inf) of Lu AG06466
Time frame: 0 (predose) up to 72 hours postdose on Day 1 to Day 12
AUC(0-inf) is defined as AUC0-tlast + Clast * t1/2 / ln2 (where Clast is the last quantifiable concentration and t1/2 is the apparent elimination half-life).
AUC(0-inf) of Metabolite Lu AG06988
Time frame: 0 (predose) up to 72 hours postdose on Day 1 to Day 12
AUC(0-inf) is defined as AUC0-tlast + Clast * t1/2 / ln2 (where Clast is the last quantifiable concentration and t1/2 is the apparent elimination half-life).
Area Under Plasma Concentration-Time Curve from Zero to Last Quantifiable Concentration (AUC0-tlast) of Lu AG06466
Time frame: 0 (predose) up to 72 hours postdose on Day 1 to Day 12
AUC0-tlast of Metabolite Lu AG06988
Time frame: 0 (predose) up to 72 hours postdose on Day 1 to Day 12
Maximum Observed Plasma Concentration (Cmax) of Lu AG06466
Time frame: 0 (predose) up to 72 hours postdose on Day 1 to Day 12
Cmax of Metabolite Lu AG06988
Time frame: 0 (predose) up to 72 hours postdose on Day 1 to Day 12
Time to Reach Cmax (Tmax) of Lu AG06466
Time frame: 0 (predose) up to 72 hours postdose on Day 1 to Day 12
Tmax of Metabolite Lu AG06988
Time frame: 0 (predose) up to 72 hours postdose on Day 1 to Day 12
Apparent Oral Clearance (CL/F) of Lu AG06466
Time frame: 0 (predose) up to 72 hours postdose on Day 1 to Day 12
CL/F is defined as dose / AUC0-inf.
Apparent Volume of Distribution (Vz/F) of Lu AG06466
Time frame: 0 (predose) up to 72 hours postdose on Day 1 to Day 12
Vz/F is defined as CL/F * t1/2 / ln2.
Apparent Elimination Half-life (t1/2) of Lu AG06466
Time frame: 0 (predose) up to 72 hours postdose on Day 1 to Day 12
t1/2 of Metabolite Lu AG06988
Time frame: 0 (predose) up to 72 hours postdose on Day 1 to Day 12
Metabolic Ratio (MR)
Time frame: 0 (predose) up to 72 hours postdose on Day 1 to Day 12
MR is defined as AUC0-inf, Lu AG06988 / AUC0-inf, Lu AG06466.
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 21 Jan 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Capsule, Lu AG06466 Tablet and Antacid in people with Healthy, run by H. Lundbeck A/S at 1 site in United Kingdom.
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 2 inclusion and 3 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 21 Jan 2022. 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 Kingdom. 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?
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity AUC(0-inf) of Lu AG06466 (time frame: 0 (predose) up to 72 hours postdose on Day 1 to Day 12). The study lists 13 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 21 Jan 2022; AzTrials last refreshed its copy on 1 Nov 2026.