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Healthy VolunteersPhase 1NCT05177029

Safety and Tolerability Study of Lu AG06466 in Healthy Young Japanese and Caucasian Participants

A Phase 1 study testing Lu AG06466 in people with Healthy Volunteers, run by H. Lundbeck A/S at 1 site in Japan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The main goal of this study is to evaluate the effect of Lu AG06466 on the body and what the body does to Lu AG06466 after single and multiple doses to healthy Japanese and Caucasian participants. Read more about this study

Who is it for?
Ages 20 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
Lu AG06466
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteJapan
Study dates
26 Nov 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 20 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • The participant has a BMI ≥18.5 and ≤25 kilograms (kg)/square meter (m^2) or ≤30 kg/m^2 for Japanese and Caucasian participants, respectively, and a body weight ≥50 kilograms (kg) 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, a neurological examination, vital signs, electrocardiograms (ECG), and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.

Who cannot join

  • The participant has taken disallowed medication <1 week prior to the first dose of study drug or <5 half-lives of the disallowed medication as concomitant use prior to the screening visit.
  • 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.
  • The participant has had a clinically significant illness <4 weeks prior to the first dose of study drug.
  • The participant has received a SARS-CoV-2 (COVID-19) vaccination <30 days prior to the first dose of study drug.
  • Note: Other inclusion and exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • P-One Clinic, Keikokai Medical Corporation

    Yokamachi Hachioji City, Tokyo, 192-0071

Other trials in Japan

About this study

Official title: Interventional, Randomized, Double-Blind, Sequential-Part, Placebo-Controlled, Single- and Multiple-Dose Study Investigating Safety, Tolerability, and Pharmacokinetic Properties of Lu AG06466 in Healthy Young Japanese and Caucasian Subjects

The main goal of this study is to evaluate the effect of Lu AG06466 on the body and what the body does to Lu AG06466 after single and multiple doses to healthy Japanese and Caucasian participants.

Read the detailed description

This sequential study will be divided in two parts, Part A and Part B.

Part A will consist of 3 cohorts (Cohorts A1, A2, and A3) in which participants will be randomized to receive a single dose of Lu AG046466 or a matching placebo orally. After completing the safety review of data from Cohort A1, the study will proceed in Cohorts A2 and A3, with an increased dose of Lu AG046466 or matching placebo being administered to Japanese and Caucasian participants.

Part B dosing will only be initiated after completion of Part A. Part B will consist of 1 cohort (Cohort B1), to which multiple dose of Lu AG046466 or matching placebo will be administered after dose titration.

Being tested
Lu AG06466, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lu AG06466Drug

    Lu AG06466 will be administered per schedule specified in the arm.

  • PlaceboDrug

    Placebo matching to Lu AG06466 will be administered per schedule specified in the arm.

Study groups in NCT05177029
Study groupRoleWhat they receive
Part A: Lu AG06466 or PlaceboExperimentalParticipants will receive single dose of Lu AG06466 capsule or matching placebo orally on Day 1.
Receives: Drug: Lu AG06466; Drug: Placebo
Part B: Lu AG06466 or PlaceboExperimentalParticipants will receive starting dose of Lu AG06466 capsule or matching placebo orally once daily from Day 1 to Day 4 followed by Lu AG06466 capsule or matching placebo at a titrated treatment dose orally once daily from Day 5 until Day 8. Participants will then receive LuAG06466 capsule or matching placebo at a higher assigned dose orally once daily from Day 9 to Day 15.
Receives: Drug: Lu AG06466; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Number of Participants With Adverse Events

    Measured: Baseline up to Day 12

  2. Part B: Number of Participants With Adverse Events

    Measured: Baseline up to Day 26

  3. Part A: Area Under the Plasma Concentration-Time Curve of Lu AG06466 and Metabolite Lu AG06988 From Zero to Infinity (AUC0-inf)

    Measured: 0 (pre-dose) up to 48 hours post-dose on Day 1 to Day 3

  4. Part B: Area Under the Plasma Concentration-Time Curve of Lu AG06466 and Metabolite Lu AG06988 in a Dosing Interval (AUC0-τ)

    Measured: 0 (pre-dose) up to 24 hours post-dose on Day 15

  5. Part A: Maximum Observed Plasma Concentration (Cmax) of Lu AG06466 and Metabolite Lu AG06988

    Measured: 0 (pre-dose) up to 48 hours post-dose on Day 1 to Day 3

  6. Part B: Cmax of Lu AG06466 and Metabolite Lu AG06988

    Measured: 0 (pre-dose) up to 24 hours post-dose on Day 1 and Day 15

  7. Part A: Nominal Time Corresponding to the Occurrence of Cmax (Tmax) of Lu AG06466 and Metabolite Lu AG06988

    Measured: 0 (pre-dose) up to 48 hours post-dose on Day 1 to Day 3

  8. Part B: Tmax of Lu AG06466 and Metabolite Lu AG06988

    Measured: 0 (pre-dose) up to 24 hours post-dose on Day 1 and Day 15

  9. Part A: Apparent Elimination Half-Life (t1/2) of Lu AG06466 and Metabolite Lu AG06988

    Measured: 0 (pre-dose) up to 48 hours post-dose on Day 1 to Day 3

  10. Part B: t1/2 of Lu AG06466 and Metabolite Lu AG06988

    Measured: 0 (pre-dose) up to 48 hours post-dose on Day 1 to Day 17

  11. Part A: Metabolic Ratio of AUC0-inf (MRAUC0-inf): AUC0-inf, Lu AG06988/AUC0-inf, Lu AG06466

    Measured: 0 (pre-dose) up to 48 hours post-dose on Day 1 to Day 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2022
  2. Study start26 Nov 2021
  3. Primary completion29 Dec 2021
  4. Study completion29 Dec 2021

Why it stopped: The study was terminated for strategic reasons.

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05177029
Sponsor's protocol ID
19891A
Status last verified
Jul 2022
First submitted
15 Dec 2021
Last updated
12 Jul 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lu AG06466 in people with Healthy Volunteers, run by H. Lundbeck A/S at 1 site in Japan.

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 5 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 12 Jul 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 Japan. 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: The study was terminated 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?

Part A: Number of Participants With Adverse Events (time frame: Baseline up to Day 12). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05177029.

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 12 Jul 2022.

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