HealthyPhase 1NCT03531229
Single Ascending Dose Study of Lu AF76432 in Healthy Young Men
A Phase 1 study testing Lu AF76432 in people with Healthy, run by H. Lundbeck A/S at 1 site in United Kingdom.
Trial summary
The purpose of this study is to investigate safety, tolerability and pharmacokinetics of the drug Lu AF76432 given as single oral ascending doses to healthy young men 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 AF76432
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Apr 2018to 22 Feb 2019
- 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 ≥18 years of age and ≤45 years of age at the Screening Visit and a body mass index (BMI) ≥18.5kg/m2 and ≤30kg/m2 at the Screening Visit.
Who cannot join
- The subject has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder or the subject is, in the opinion of the investigator, unlikely to comply with the protocol or is unsuitable for any reason
- The subject has taken any investigational medicinal product <3 months prior to the first dose of IMP
- 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 AF76432 in Healthy Young Men
The purpose of this study is to investigate safety, tolerability and pharmacokinetics of the drug Lu AF76432 given as single oral ascending doses to healthy young men
- Conditions
- Healthy
- Being tested
- Placebo, Lu AF76432
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo to Lu AF76432 oral solution
Lu AF76432Drug
Lu AF76432 oral solution 2.5 mg/ml. Starting dose will be 3,5 mg, actual doses for following cohorts will be defined based on results from preceding dosing group(s).
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo to Lu AF76432 Receives: Drug: Placebo |
| Lu AF76432 | Experimental | Lu AF76432 Receives: Drug: Lu AF76432 |
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 (clinical safety laboratory tests, vital signs, weight, ECG parameters and physical examination)
Measured: From dosing to 12 days
Secondary outcomes (4)
AUC0-t
Area under the plasma concentration-time curve from zero to time t
Measured: From dosing to 72 hours post dose
Cmax
Maximum observed concentration
Measured: From dosing to 72 hours post dose
AUC0-inf
Area under the plasma concentration-time curve from zero to infinity
Measured: From dosing to 72 hours post dose
CL/F
Oral clearance
Measured: From dosing to 72 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start17 Apr 2018
- Primary completion22 Feb 2019
- Study completion22 Feb 2019
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
- 36 Subjects are planned for enrolment, with 6 subjects per cohort. The subjects will be randomized to Lu AF76432 or placebo in a 4:2 ratio per cohort. A maximum of 2 additional cohorts of young healthy men will be permitted thereby allowing investigation of a maximum of 48 subjects
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 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
- NCT03531229
- Sponsor's protocol ID
- 17479A
- Status last verified
- Apr 2019
- First submitted
- 20 Apr 2018
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. 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 AF76432 in Healthy Young Men
- ClinicalTrials.gov ID
- NCT03531229
- Acronym / sponsor ID
- 17479A
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2018 (actual)
- Primary completion
- 22 Feb 2019 (actual)
- Study completion
- 22 Feb 2019 (actual)
- First posted
- 21 May 2018 (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 safety, tolerability and pharmacokinetics of the drug Lu AF76432 given as single oral ascending doses to healthy young men
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 36 Subjects are planned for enrolment, with 6 subjects per cohort. The subjects will be randomized to Lu AF76432 or placebo in a 4:2 ratio per cohort. A maximum of 2 additional cohorts of young healthy men will be permitted thereby allowing investigation of a maximum of 48 subjects
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo to Lu AF76432 |
| Lu AF76432 | Experimental | Drug: Lu AF76432Lu AF76432 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -Healthy young non-smoking men ≥18 years of age and ≤45 years of age at the Screening Visit and a body mass index (BMI) ≥18.5kg/m2 and ≤30kg/m2 at the Screening Visit.
Key exclusion criteria (3 listed)
- The subject has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder or the subject is, in the opinion of the investigator, unlikely to comply with the protocol or is unsuitable for any reason
- The subject has taken any investigational medicinal product <3 months prior to the first dose of IMP
- 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 |
|---|---|---|
| PlaceboPlacebo to Lu AF76432 oral solution | Drug | Placebo |
| Lu AF76432Lu AF76432 oral solution 2.5 mg/ml. Starting dose will be 3,5 mg, actual doses for following cohorts will be defined based on results from preceding dosing group(s). | Drug | Lu AF76432 |
Primary outcome
Number of participants with Treatment-Emergent Adverse Events
Time frame: From dosing to 12 days
Safety and Tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, ECG parameters and physical examination)
4 secondary outcomes
AUC0-t
Time frame: From dosing to 72 hours post dose
Cmax
Time frame: From dosing to 72 hours post dose
AUC0-inf
Time frame: From dosing to 72 hours post dose
CL/F
Time frame: From dosing to 72 hours post dose
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 12 Apr 2019.
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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 AF76432 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 1 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 12 Apr 2019. 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. Some participants in this study may receive a placebo. 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?
Number of participants with Treatment-Emergent Adverse Events (time frame: From dosing to 12 days). 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 12 Apr 2019.