HealthyPhase 1NCT05003687
Safety and Tolerability of Lu AG06474 in Healthy Young Men
A Phase 1 study testing Lu AG06474 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 investigate the safety and tolerability of Lu AG06474 and what the body does to Lu AG06474 after swallowing single doses of the drug. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- 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
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2021to 22 Dec 2022
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The participant has a body mass index (BMI) ≥18.5 and ≤30 kilograms (kg)/square meter (m^2) at the Screening Visit and at the Safety Baseline/Baseline Visit.
- The participant is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, vital signs, a safety 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 prior to the Screening Visit for any medication taken.
- The participant has orthostatic hypotension, defined as a decrease in systolic blood pressure ≥20 millimeters of mercury (mmHg) and/or a decrease in diastolic blood pressure ≥10 mmHg from supine to standing, at the Screening Visit or at the Safety Baseline/Baseline Visit.
- The participant has a QTcF interval >450 milliseconds (ms) at the Screening Visit or at the Safety Baseline/Baseline Visit, as calculated by the ECG equipment and evaluated by the investigator.
- The participant has taken any investigational medicinal product <3 months prior to the first dose of study drug.
- The participant has received an injection of COVID-19 vaccination less than 30 days prior to the first dose of study drug.
- Other inclusion and exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventional, Randomized, Double-Blind, Sequential-Group, Placebo-Controlled, Single-Ascending Oral Dose Study Investigating the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of Lu AG06474 and Open-Label, Cross-Over Study to Investigate Intra-Subject Variability and the Effect of Food in Healthy Young Men
The purpose of this study is to investigate the safety and tolerability of Lu AG06474 and what the body does to Lu AG06474 after swallowing single doses of the drug.
Read the detailed description
Part A: randomized, double-blind, sequential. Part B: randomized, open-label, cross-over.
- Conditions
- Healthy
- 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
solution, orally (Parts A and B)
PlaceboDrug
solution, orally (Part A only)
| Study group | Role | What they receive |
|---|---|---|
| Part A: Single Dose of Lu AG06474 or Placebo | Experimental | Participants will receive single oral dose of Lu AG06474 or placebo. Receives: Drug: Lu AG06474; Drug: Placebo |
| Part B: Repeated Dose of Lu AG06474 and Food Interaction | Experimental | Participants will receive a single oral dose of Lu AG06474 in each dosing period (Period 1, 2, and 3) in the following sequence:
Sequence B1: Fed - Fasting- Fasting
Sequence B2: Fasting- Fed - Fasting
Sequence B3: Fasting- Fasting - Fed 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
Measured: From Baseline to Day 8
Part A: Electrocardiogram (ECG) Parameter (Delta QTcF) at 24 Hours on Day 1
Measured: Day 1
Part A: Change From Pre-Dose Baseline in ECG Parameter (Delta QTcF) at 24 Hours on Day 1
Measured: Pre-dose Baseline (Day -1), Day 1
Part A: Bond-Lader VAS Dimension Scores at Day 4
Measured: Day 4
Part A: Change From Pre-Dose Baseline in the Bond-Lader VAS Dimension Scores at Day 4
Measured: Pre-dose Baseline (Day -1), Day 4
Part A: Percentage of Peripheral Blood Mononuclear Cells (PBMC)-Mediated Hydrolysis of 2-arachidonolylglycerol (2-AG) Ex Vivo (% of Pre-Dose Measurement of Arachidonic Acid [AA])
Measured: From pre-dose to Day 4
Parts A and B: AUC0-inf of Lu AG06474
Area under the Lu AG06474 concentration-time curve from time zero to infinity (AUC0-inf)
Measured: From pre-dose to Day 4
Parts A and B: Cmax of Lu AG06474
Maximum observed plasma concentration for Lu AG06474
Measured: From pre-dose to Day 4
Parts A and B: Tmax of Lu AG06474
Nominal time corresponding to the occurrence of Cmax of Lu AG06474
Measured: From pre-dose to Day 4
Part A: t1/2 of Lu AG06474
Apparent elimination half-life of Lu AG06474
Measured: From pre-dose to Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start4 Aug 2021
- Primary completion22 Dec 2022
- Study completion22 Dec 2022
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
- Model description
- Part A: randomized, double-blind, sequential. Part B: randomized, open-label, cross-over.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 79 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, H. Lundbeck A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05003687
- Sponsor's protocol ID
- 19702A
- Status last verified
- Jan 2023
- First submitted
- 6 Aug 2021
- Last updated
- 9 Jan 2023
- 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 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Randomized, Double-Blind, Sequential-Group, Placebo-Controlled, Single-Ascending Oral Dose Study Investigating the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of Lu AG06474 and Open-Label, Cross-Over Study to Investigate Intra-Subject Variability and the Effect of Food in Healthy Young Men
- ClinicalTrials.gov ID
- NCT05003687
- Acronym / sponsor ID
- 19702A
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2021 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 12 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 purpose of this study is to investigate the safety and tolerability of Lu AG06474 and what the body does to Lu AG06474 after swallowing single doses of the drug.
Detailed description
Part A: randomized, double-blind, sequential. Part B: randomized, open-label, cross-over.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Part A: randomized, double-blind, sequential. Part B: randomized, open-label, cross-over.
| Arm | Type | Receives |
|---|---|---|
| Part A: Single Dose of Lu AG06474 or Placebo | Experimental | Drug: Lu AG06474, Drug: PlaceboParticipants will receive single oral dose of Lu AG06474 or placebo. |
| Part B: Repeated Dose of Lu AG06474 and Food Interaction | Experimental | Drug: Lu AG06474Participants will receive a single oral dose of Lu AG06474 in each dosing period (Period 1, 2, and 3) in the following sequence: Sequence B1: Fed - Fasting- Fasting Sequence B2: Fasting- Fed - Fasting Sequence B3: Fasting- Fasting - Fed |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- The participant has a body mass index (BMI) ≥18.5 and ≤30 kilograms (kg)/square meter (m^2) at the Screening Visit and at the Safety Baseline/Baseline Visit.
- The participant is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, vital signs, a safety ECG, and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.
Key exclusion criteria (6 listed)
- The participant has taken disallowed medication <1 week prior to the first dose of study drug or <5 half-lives prior to the Screening Visit for any medication taken.
- The participant has orthostatic hypotension, defined as a decrease in systolic blood pressure ≥20 millimeters of mercury (mmHg) and/or a decrease in diastolic blood pressure ≥10 mmHg from supine to standing, at the Screening Visit or at the Safety Baseline/Baseline Visit.
- The participant has a QTcF interval >450 milliseconds (ms) at the Screening Visit or at the Safety Baseline/Baseline Visit, as calculated by the ECG equipment and evaluated by the investigator.
- The participant has taken any investigational medicinal product <3 months prior to the first dose of study drug.
- The participant has received an injection of COVID-19 vaccination less than 30 days prior to the first dose of study drug.
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 AG06474solution, orally (Parts A and B) | Drug | Part A: Single Dose of Lu AG06474 or Placebo, Part B: Repeated Dose of Lu AG06474 and Food Interaction |
| Placebosolution, orally (Part A only) | Drug | Part A: Single Dose of Lu AG06474 or Placebo |
Primary outcome
Parts A and B: Number of participants With Treatment-Emergent Adverse Events
Time frame: From Baseline to Day 8
Part A: Electrocardiogram (ECG) Parameter (Delta QTcF) at 24 Hours on Day 1
Time frame: Day 1
Part A: Change From Pre-Dose Baseline in ECG Parameter (Delta QTcF) at 24 Hours on Day 1
Time frame: Pre-dose Baseline (Day -1), Day 1
Part A: Bond-Lader VAS Dimension Scores at Day 4
Time frame: Day 4
Part A: Change From Pre-Dose Baseline in the Bond-Lader VAS Dimension Scores at Day 4
Time frame: Pre-dose Baseline (Day -1), Day 4
Part A: Percentage of Peripheral Blood Mononuclear Cells (PBMC)-Mediated Hydrolysis of 2-arachidonolylglycerol (2-AG) Ex Vivo (% of Pre-Dose Measurement of Arachidonic Acid [AA])
Time frame: From pre-dose to Day 4
Parts A and B: AUC0-inf of Lu AG06474
Time frame: From pre-dose to Day 4
Area under the Lu AG06474 concentration-time curve from time zero to infinity (AUC0-inf)
Parts A and B: Cmax of Lu AG06474
Time frame: From pre-dose to Day 4
Maximum observed plasma concentration for Lu AG06474
Parts A and B: Tmax of Lu AG06474
Time frame: From pre-dose to Day 4
Nominal time corresponding to the occurrence of Cmax of Lu AG06474
Part A: t1/2 of Lu AG06474
Time frame: From pre-dose to Day 4
Apparent elimination half-life of Lu AG06474
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 9 Jan 2023.
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
H. Lundbeck A/S
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, 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 2 inclusion and 6 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 9 Jan 2023. 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?
Parts A and B: Number of participants With Treatment-Emergent Adverse Events (time frame: From Baseline to Day 8). The study lists 10 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 9 Jan 2023.