HealthyPhase 1NCT04473651
Safety and Tolerability of Lu AG06479 in Healthy Young Men
A Phase 1 study testing Lu AG06479 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 AG06479 and what the body does to Lu AG06479 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 AG06479
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2020to 10 Nov 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, young, non-smoking men, weight ≥60 kg, and a body mass index (BMI) ≥18.5 kg/m2 and ≤30 kg/m2 at the Screening Visit.
- Other in- and exclusion criteria may apply
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventional, Randomized, Double-blind, Placebo-controlled, Sequential-group, Single-ascending Oral Dose Study Investigating the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Properties of Lu AG06479 and Open-label Cross-over Study to Investigate Intra-subject Variability and Effect of Food in Healthy Young Men
The purpose of this study is to investigate the safety and tolerability of Lu AG06479 and what the body does to Lu AG06479 after swallowing single doses of the drug.
Read the detailed description
Part A: randomized, sequential
Part B: open-label, cross-over
- Conditions
- Healthy
- Being tested
- Lu AG06479, Placebos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AG06479Drug
Also called ABX-1762
capsules, orally (Part A and B)
PlacebosDrug
Placebo - capsules, orally (Part A only)
| Study group | Role | What they receive |
|---|---|---|
| Part A: Single dose of Lu AG06479 or Placebo | Experimental | Not described Receives: Drug: Lu AG06479; Drug: Placebos |
| Part B: Repeated dose of Lu AG06479 and Food interaction | Experimental | Sequence B1: Fed - Fasting - Fasting
Sequence B2: Fasting- Fed - Fasting
Sequence B3: Fasting- Fasting - Fed Receives: Drug: Lu AG06479 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment emergent adverse events (Safety and Tolerability)
Based on the safety assessments (e.g. clinical safety laboratory tests, vital signs, weight and ECG parameters)
Measured: From baseline to Day 9 (Part A and B)
Secondary outcomes (3)
AUC (0-inf) of Lu AG06479
Area under the Lu AG06479 concentration-time curve from time zero to infinity (AUC0-inf)
Measured: From pre-dose to Day 5 (Part A and B)
CL/F Lu AG06479
Oral clearance of Lu AG06479
Measured: From pre-dose to Day 5 (Part A and B)
Cmax Lu AG06479
Maximum observed plasma concentration for Lu AG06479
Measured: From pre-dose to Day 5 (Part A and B)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start9 Jul 2020
- Primary completion10 Nov 2021
- Study completion10 Nov 2021
Why it stopped: The study was terminated for strategic reasons.
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 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
- NCT04473651
- Sponsor's protocol ID
- 18452A
- Status last verified
- Nov 2021
- First submitted
- 13 Jul 2020
- Last updated
- 14 Dec 2021
- 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 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Randomized, Double-blind, Placebo-controlled, Sequential-group, Single-ascending Oral Dose Study Investigating the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Properties of Lu AG06479 and Open-label Cross-over Study to Investigate Intra-subject Variability and Effect of Food in Healthy Young Men
- ClinicalTrials.gov ID
- NCT04473651
- Acronym / sponsor ID
- 18452A
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated for strategic reasons.
- Enrolment
- 46 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- 10 Nov 2021 (actual)
- Study completion
- 10 Nov 2021 (actual)
- First posted
- 16 Jul 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.
The purpose of this study is to investigate the safety and tolerability of Lu AG06479 and what the body does to Lu AG06479 after swallowing single doses of the drug.
Detailed description
Part A: randomized, sequential
Part B: open-label, cross-over
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: Single dose of Lu AG06479 or Placebo | Experimental | Drug: Lu AG06479, Drug: Placebos |
| Part B: Repeated dose of Lu AG06479 and Food interaction | Experimental | Drug: Lu AG06479Sequence 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)
- Healthy, young, non-smoking men, weight ≥60 kg, and a body mass index (BMI) ≥18.5 kg/m2 and ≤30 kg/m2 at the Screening Visit.
- Other in- and exclusion criteria may apply
Key exclusion criteria (0 listed)
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 AG06479Also: ABX-1762capsules, orally (Part A and B) | Drug | Part A: Single dose of Lu AG06479 or Placebo, Part B: Repeated dose of Lu AG06479 and Food interaction |
| PlacebosPlacebo - capsules, orally (Part A only) | Drug | Part A: Single dose of Lu AG06479 or Placebo |
Primary outcome
Number of participants with treatment emergent adverse events (Safety and Tolerability)
Time frame: From baseline to Day 9 (Part A and B)
Based on the safety assessments (e.g. clinical safety laboratory tests, vital signs, weight and ECG parameters)
3 secondary outcomes
AUC (0-inf) of Lu AG06479
Time frame: From pre-dose to Day 5 (Part A and B)
CL/F Lu AG06479
Time frame: From pre-dose to Day 5 (Part A and B)
Cmax Lu AG06479
Time frame: From pre-dose to Day 5 (Part A and B)
Results and safety
The study was stopped early (reason given: The study was terminated for strategic reasons.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
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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 AG06479 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 0 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 14 Dec 2021. 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: 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?
Number of participants with treatment emergent adverse events (Safety and Tolerability) (time frame: From baseline to Day 9 (Part A and B)). 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 Dec 2021.