HealthyPhase 1NCT03565094
Single Dose of Lu AF28996 to Healthy Young Men
A Phase 1 study testing Lu AF28996 solution and Lu AF28996 capsule in people with Healthy, run by H. Lundbeck A/S at 1 site in Netherlands.
Trial summary
This study evaluates how increasing doses of Lu AF28996 enters, moves through and exits the body when given by mouth 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 AF28996 solution and Lu AF28996 capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteNetherlands
- Study dates
- 29 May 2018to 21 Aug 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 aged ≥18 and ≤45 years and with a body mass index (BMI) ≥18.5kg/m2 and ≤30kg/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, Open-label, Single- and Sequential-ascending-dose Study Investigating the Safety, Tolerability and Pharmacokinetic Profile of Lu AF28996 in Healthy Young Men
This study evaluates how increasing doses of Lu AF28996 enters, moves through and exits the body when given by mouth to healthy young men.
Read the detailed description
Part A of the study consists of 6 groups (Cohorts 1 to 6) with 3 subjects in each, with the possibility of 4 additional cohorts. In cohort 1, the subjects will receive a single dose of Lu AF28996 by mouth. Following evaluation of data from the first dose, the subjects in the following cohorts are planned to receive two single increasing doses by mouth of Lu AF28996 on 2 separate days with a wash out (day or days without dosing) in between.
Part B is an open-label three-period crossover study in healthy young men to compare the PK of an oral capsule formulation with that of an oral solution formulation and to evaluate food effect following oral capsule administration of Lu AF28996.The subjects will be randomised to one of the four treatment sequences
- Conditions
- Healthy
- Being tested
- Lu AF28996 solution, Lu AF28996 capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AF28996 solutionDrug
Oral solution (0.1-0.2 mg/mL)
Following each cohort, a dosing conference will be held where tolerability, safety and preliminary PK results from the previous cohorts will be reviewed before deciding on the next doses
Lu AF28996 capsuleDrug
hard capsule orally QD: one dose lower than the highest dose level in part A
| Study group | Role | What they receive |
|---|---|---|
| Lu AF28996 | Experimental | Lu AF28996 solution, cohort depending dose
Part A:
Cohort 1: single oral dose of Lu AF28996
Cohorts 2-6: two single ascending oral doses of Lu AF28996 with a washout in between
Possibility of 4 additional cohorts (Cohorts 7 to 10), allowing for the investigation of a potential 13 additional subjects
Part B: 8 subjects (randomised to one of four treatment sequences) Receives: Drug: Lu AF28996 solution; Drug: Lu AF28996 capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC 0-inf
area under the plasma concentration-time curve of Lu AF28996
Measured: From dosing to day 12 postdose
Cmax
maximum observed plasma concentration of Lu AF28996
Measured: From dosing to day 12 postdose
CL/F
Oral clearance of Lu AF28996
Measured: From dosing to day 12 postdose
Secondary outcomes (1)
Number of participants with Treatment-Emergent Adverse Events
Safety and Tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight and ECG parameters)
Measured: From dosing to day 12 postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start29 May 2018
- Primary completion17 Aug 2019
- Study completion21 Aug 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 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
- NCT03565094
- Sponsor's protocol ID
- 17695A
- Status last verified
- Sep 2019
- First submitted
- 8 Jun 2018
- Last updated
- 26 Sep 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 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Open-label, Single- and Sequential-ascending-dose Study Investigating the Safety, Tolerability and Pharmacokinetic Profile of Lu AF28996 in Healthy Young Men
- ClinicalTrials.gov ID
- NCT03565094
- Acronym / sponsor ID
- 17695A
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 29 May 2018 (actual)
- Primary completion
- 17 Aug 2019 (actual)
- Study completion
- 21 Aug 2019 (actual)
- First posted
- 21 Jun 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.
This study evaluates how increasing doses of Lu AF28996 enters, moves through and exits the body when given by mouth to healthy young men.
Detailed description
Part A of the study consists of 6 groups (Cohorts 1 to 6) with 3 subjects in each, with the possibility of 4 additional cohorts. In cohort 1, the subjects will receive a single dose of Lu AF28996 by mouth. Following evaluation of data from the first dose, the subjects in the following cohorts are planned to receive two single increasing doses by mouth of Lu AF28996 on 2 separate days with a wash out (day or days without dosing) in between.
Part B is an open-label three-period crossover study in healthy young men to compare the PK of an oral capsule formulation with that of an oral solution formulation and to evaluate food effect following oral capsule administration of Lu AF28996.The subjects will be randomised to one of the four treatment sequences
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lu AF28996 | Experimental | Drug: Lu AF28996 solution, Drug: Lu AF28996 capsuleLu AF28996 solution, cohort depending dose Part A: Cohort 1: single oral dose of Lu AF28996 Cohorts 2-6: two single ascending oral doses of Lu AF28996 with a washout in between Possibility of 4 additional cohorts (Cohorts 7 to 10), allowing for the investigation of a potential 13 additional subjects Part B: 8 subjects (randomised to one of four treatment sequences) |
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 aged ≥18 and ≤45 years and with a body mass index (BMI) ≥18.5kg/m2 and ≤30kg/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 AF28996 solutionOral solution (0.1-0.2 mg/mL) Following each cohort, a dosing conference will be held where tolerability, safety and preliminary PK results from the previous cohorts will be reviewed before deciding on the next doses | Drug | Lu AF28996 |
| Lu AF28996 capsulehard capsule orally QD: one dose lower than the highest dose level in part A | Drug | Lu AF28996 |
Primary outcome
AUC 0-inf
Time frame: From dosing to day 12 postdose
area under the plasma concentration-time curve of Lu AF28996
Cmax
Time frame: From dosing to day 12 postdose
maximum observed plasma concentration of Lu AF28996
CL/F
Time frame: From dosing to day 12 postdose
Oral clearance of Lu AF28996
1 secondary outcome
Number of participants with Treatment-Emergent Adverse Events
Time frame: From dosing to day 12 postdose
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 26 Sep 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 AF28996 solution and Lu AF28996 capsule in people with Healthy, run by H. Lundbeck A/S at 1 site in Netherlands.
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: finished, as of the sponsor's last update on 26 Sep 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 Netherlands. 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?
AUC 0-inf (time frame: From dosing to day 12 postdose). The study lists 3 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 26 Sep 2019; AzTrials last refreshed its copy on 8 Nov 2026.