Healthy ParticipantsPhase 1NCT05943327
A Study Investigating Lu AG06474 in Healthy Young Participants
A Phase 1 study testing Lu AG06474 in people with Healthy Participants, run by H. Lundbeck A/S at 1 site in United States.
Trial summary
The purpose of this study is to investigate the safety of multiple oral doses of Lu AG06474, how well the doses are tolerated, and what the body does to the drug after administering it to healthy young participants. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Lu AG06474
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2023to 19 Jul 2024
- 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
- The participant has a body mass index (BMI) ≥18.5 and ≤30 kilograms per meter squared (kg/m^2) at the Screening Visit and at the Baseline Visit.
- The participant has a resting supine pulse ≥50 and ≤100 beats per minute (bpm) at the Screening Visit and at the Baseline Visit. For physically/athletically well-trained participants, the lower limit is ≥45 bpm.
- The participant has a resting supine systolic blood pressure ≥91 and ≤140 millimeters of mercury (mmHg) and a resting supine diastolic blood pressure ≥51 and ≤85 mmHg at the Screening Visit and at the Baseline Visit.
Who cannot join
- The participant has previously been dosed with Lu AG06474.
- The participant has participated in a clinical trial <30 days prior to the Screening Visit.
- The participant has taken any investigational medicinal product ≥30 days or <5 half-lives of that product, whichever is longer, prior to the first dose of IMP.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventional, Randomized, Double-blind, Sequential Cohort, Placebo-controlled, Multiple-dose Trial Investigating the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Properties of Lu AG06474 in Healthy Young Men and Women, With an Open-label, Cross-over, Single-dose Part Investigating the Relative Bioavailability of a Capsule Formulation
The purpose of this study is to investigate the safety of multiple oral doses of Lu AG06474, how well the doses are tolerated, and what the body does to the drug after administering it to healthy young participants. This study also aims to compare how the body absorbs and uses Lu AG06474 when it is given in capsule form versus when it is given as an oral solution.
Read the detailed description
The study has 2 parts: Part A and Part B.
Part A consists of up to 7 sequential cohorts (Cohorts A1 to A7), with 8 participants per cohort randomized to receive multiple doses of either Lu AG06474 or placebo: 6 will receive Lu AG06474 oral solution and 2 will receive placebo.
Part B consists of 1 cohort (Cohort B1), with 12 participants: all participants will receive 2 single doses of Lu AG06474 (one as an oral solution and one in capsule form), taken 3 days apart.
- Conditions
- Healthy Participants
- Being tested
- Lu AG06474, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AG06474Drug
Oral Solution
PlaceboDrug
Oral Solution
Lu AG06474Drug
Capsule
| Study group | Role | What they receive |
|---|---|---|
| Part A: Multiple Doses of Lu AG06474 or Placebo | Experimental | Participants will receive multiple oral doses of Lu AG06474 or placebo. Receives: Drug: Lu AG06474; Drug: Placebo |
| Part B: Single Doses of Lu AG06474 | Experimental | Participants will receive single oral doses of Lu AG06474. Receives: Drug: Lu AG06474 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parts A and B: Number of Participants with Treatment Emergent Adverse Events (AEs)
Measured: Up to Day 10
Part A: Electrocardiogram (ECG) Parameter (delta QTcF) on Day 5
Measured: Day 5
Part A: AUC0-τ: Area Under the Lu AG06474 Plasma Concentration Curve During Dosing Interval
Measured: Predose to Day 7
Parts A and B: Cmax: Maximum Observed Plasma Concentration of Lu AG06474
Measured: Predose to Day 6
Parts A and B: Tmax: Nominal Time Corresponding to the Occurrence of Cmax
Measured: Predose to Day 6
Parts A and B: t½: Apparent Elimination Half-life of Lu AG06474
Measured: Predose to Day 6
Part B: AUC0-infinity: Area Under the Lu AG06474 Plasma Concentration Curve From Zero to Infinity
Measured: Predose to Day 6
Part A: Accumulation Index
Measured: Predose to Day 7
Part B: Frel: Relative Bioavailability
Measured: Predose to Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start28 Jun 2023
- Primary completion19 Jul 2024
- Study completion19 Jul 2024
Why it stopped: For strategic reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 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
- NCT05943327
- Sponsor's protocol ID
- 20065A
- Status last verified
- Nov 2024
- First submitted
- 16 Jun 2023
- Last updated
- 18 Nov 2024
- 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 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Randomized, Double-blind, Sequential Cohort, Placebo-controlled, Multiple-dose Trial Investigating the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Properties of Lu AG06474 in Healthy Young Men and Women, With an Open-label, Cross-over, Single-dose Part Investigating the Relative Bioavailability of a Capsule Formulation
- ClinicalTrials.gov ID
- NCT05943327
- Acronym / sponsor ID
- 20065A
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: For strategic reasons
- Enrolment
- 56 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2023 (actual)
- Primary completion
- 19 Jul 2024 (actual)
- Study completion
- 19 Jul 2024 (actual)
- First posted
- 13 Jul 2023 (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 investigate the safety of multiple oral doses of Lu AG06474, how well the doses are tolerated, and what the body does to the drug after administering it to healthy young participants. This study also aims to compare how the body absorbs and uses Lu AG06474 when it is given in capsule form versus when it is given as an oral solution.
Detailed description
The study has 2 parts: Part A and Part B.
Part A consists of up to 7 sequential cohorts (Cohorts A1 to A7), with 8 participants per cohort randomized to receive multiple doses of either Lu AG06474 or placebo: 6 will receive Lu AG06474 oral solution and 2 will receive placebo.
Part B consists of 1 cohort (Cohort B1), with 12 participants: all participants will receive 2 single doses of Lu AG06474 (one as an oral solution and one in capsule form), taken 3 days apart.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: Multiple Doses of Lu AG06474 or Placebo | Experimental | Drug: Lu AG06474, Drug: PlaceboParticipants will receive multiple oral doses of Lu AG06474 or placebo. |
| Part B: Single Doses of Lu AG06474 | Experimental | Drug: Lu AG06474Participants will receive single oral doses of Lu AG06474. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- The participant has a body mass index (BMI) ≥18.5 and ≤30 kilograms per meter squared (kg/m^2) at the Screening Visit and at the Baseline Visit.
- The participant has a resting supine pulse ≥50 and ≤100 beats per minute (bpm) at the Screening Visit and at the Baseline Visit. For physically/athletically well-trained participants, the lower limit is ≥45 bpm.
- The participant has a resting supine systolic blood pressure ≥91 and ≤140 millimeters of mercury (mmHg) and a resting supine diastolic blood pressure ≥51 and ≤85 mmHg at the Screening Visit and at the Baseline Visit.
Key exclusion criteria (3 listed)
- The participant has previously been dosed with Lu AG06474.
- The participant has participated in a clinical trial <30 days prior to the Screening Visit.
- The participant has taken any investigational medicinal product ≥30 days or <5 half-lives of that product, whichever is longer, prior to the first dose of IMP.
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 AG06474Oral Solution | Drug | Part A: Multiple Doses of Lu AG06474 or Placebo, Part B: Single Doses of Lu AG06474 |
| PlaceboOral Solution | Drug | Part A: Multiple Doses of Lu AG06474 or Placebo |
| Lu AG06474Capsule | Drug | Part B: Single Doses of Lu AG06474 |
Primary outcome
Parts A and B: Number of Participants with Treatment Emergent Adverse Events (AEs)
Time frame: Up to Day 10
Part A: Electrocardiogram (ECG) Parameter (delta QTcF) on Day 5
Time frame: Day 5
Part A: AUC0-τ: Area Under the Lu AG06474 Plasma Concentration Curve During Dosing Interval
Time frame: Predose to Day 7
Parts A and B: Cmax: Maximum Observed Plasma Concentration of Lu AG06474
Time frame: Predose to Day 6
Parts A and B: Tmax: Nominal Time Corresponding to the Occurrence of Cmax
Time frame: Predose to Day 6
Parts A and B: t½: Apparent Elimination Half-life of Lu AG06474
Time frame: Predose to Day 6
Part B: AUC0-infinity: Area Under the Lu AG06474 Plasma Concentration Curve From Zero to Infinity
Time frame: Predose to Day 6
Part A: Accumulation Index
Time frame: Predose to Day 7
Part B: Frel: Relative Bioavailability
Time frame: Predose to Day 6
Results and safety
The study was stopped early (reason given: For strategic reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
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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 AG06474 in people with Healthy Participants, 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 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: stopped early, as of the sponsor's last update on 18 Nov 2024. 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 was stopped early (reason given: For strategic reasons). Results are not available in the source record.
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?
Parts A and B: Number of Participants with Treatment Emergent Adverse Events (AEs) (time frame: Up to Day 10). The study lists 9 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 18 Nov 2024.