HealthyPhase 1NCT04104503
A Study Investigating Tablet Formulations of Lu AF11167 in Healthy Subjects
A Phase 1 study testing Lu AF11167, [14C]-Lu AF11167 and Lu AF11167 MR tablet prototype formulation selected from part A or 1 mg modified release tablet (reference formulation) 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 the extent to which Lu AF11167 enters the bloodstream following tablet intake and the influence of food on uptake in healthy men and women Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lu AF11167, [14C]-Lu AF11167 and Lu AF11167 MR tablet prototype formulation selected from part A or 1 mg modified release tablet (reference formulation)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Sep 2019to 9 Apr 2020
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) of ≥18.5 and ≤30.0 kg/m2
- (Part B only) Women of child-bearing potential will have a confirmed non-pregnant and non-lactating status
Who cannot join
- The subject has any concurrent disorder that may affect the particular target or absorption, distribution, or elimination of the investigational medical product
- Other in- and exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventional, Open-label, Two-part, Partly-randomized Study Investigating the Pharmacokinetic Properties, Absolute Bioavailability, Food Effect, and Intra-subject Variability of up to 5 Prototype Modified-release Tablet Formulations of Lu AF11167 in Healthy Subjects
The purpose of this study is to investigate the extent to which Lu AF11167 enters the bloodstream following tablet intake and the influence of food on uptake in healthy men and women
Read the detailed description
This study will be split into Part A and Part B. Part A will happen first and will look at new tablet formulations of the test medicine compared to a previously known formulation (reference tablet). The results from Part A of the study will be used to decide which formulation will be tested in Part B of the study. Part B of the study will look at the food effect, variability between participants, and absolute bioavailability of the test medicine i.e. how much of the test medicine is taken up by the body when dosed by mouth compared to when dosed once by injection directly into the vein. Safety and tolerability will be assessed throughout the study.
- Conditions
- Healthy
- Being tested
- Lu AF11167, [14C]-Lu AF11167, Lu AF11167 MR tablet prototype formulation selected from part A or 1 mg modified release tablet (reference formulation)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AF11167Drug
Lu AF11167 - 2 mg modified release tablets (reference formulation), up to 5 prototype MR tablet formulations (test formulations)
[14C]-Lu AF11167Drug
single iv microdose administered as a 15 minutes infusion
Lu AF11167 MR tablet prototype formulation selected from part A or 1 mg modified release tablet (reference formulation)Drug
Single oral dose
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Not described Receives: Drug: Lu AF11167 |
| Part B group 1 | Experimental | Treatment period 1: Fasted + iv;
Treatment period 2: Fasted;
Treatment period 3: High-fat meal Receives: Drug: [14C]-Lu AF11167; Drug: Lu AF11167 MR tablet prototype formulation selected from part A or 1 mg modified release tablet (reference formulation) |
| Part B group 2 | Experimental | Treatment period 1: High-fat meal;
Treatment period 2: Fasted + iv;
Treatment period 3: Fasted Receives: Drug: [14C]-Lu AF11167; Drug: Lu AF11167 MR tablet prototype formulation selected from part A or 1 mg modified release tablet (reference formulation) |
| Part B group 3 | Experimental | Treatment period 1: Fasted;
Treatment period 2: High-fat meal;
Treatment period 3: Fasted + iv Receives: Drug: [14C]-Lu AF11167; Drug: Lu AF11167 MR tablet prototype formulation selected from part A or 1 mg modified release tablet (reference formulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of Lu AF11167
Maximum observed plasma concentration
Measured: From 0 to 48 hours
AUC(0-inf) of Lu AF11167
Area under the plasma concentration time curve from zero to infinity
Measured: From 0 to 48 hours
Relative bioavailability F(rel) of Lu AF11167
F(rel) is estimated as the dose normalized AUC(inf) for the test formulation relative to the reference formulation (part A only)
Measured: From 0 to 48 hours
Absolute bioavailability F(abs) of Lu AF11167
F(abs) is estimated as the dose normalized AUC(inf) for the test formulation relative to the intravenous reference formulation (part B only)
Measured: From 0 to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start17 Sep 2019
- Primary completion9 Apr 2020
- Study completion9 Apr 2020
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
- None (open label)
- Enrolment
- 33 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
- NCT04104503
- Sponsor's protocol ID
- 18153A
- Status last verified
- Apr 2020
- First submitted
- 24 Sep 2019
- Last updated
- 17 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Open-label, Two-part, Partly-randomized Study Investigating the Pharmacokinetic Properties, Absolute Bioavailability, Food Effect, and Intra-subject Variability of up to 5 Prototype Modified-release Tablet Formulations of Lu AF11167 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04104503
- Acronym / sponsor ID
- 18153A
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- 9 Apr 2020 (actual)
- Study completion
- 9 Apr 2020 (actual)
- First posted
- 26 Sep 2019 (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 extent to which Lu AF11167 enters the bloodstream following tablet intake and the influence of food on uptake in healthy men and women
Detailed description
This study will be split into Part A and Part B. Part A will happen first and will look at new tablet formulations of the test medicine compared to a previously known formulation (reference tablet). The results from Part A of the study will be used to decide which formulation will be tested in Part B of the study. Part B of the study will look at the food effect, variability between participants, and absolute bioavailability of the test medicine i.e. how much of the test medicine is taken up by the body when dosed by mouth compared to when dosed once by injection directly into the vein. Safety and tolerability will be assessed throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: Lu AF11167 |
| Part B group 1 | Experimental | Drug: [14C]-Lu AF11167, Drug: Lu AF11167 MR tablet prototype formulation selected from part A or 1 mg modified release tablet (reference formulation)Treatment period 1: Fasted + iv; Treatment period 2: Fasted; Treatment period 3: High-fat meal |
| Part B group 2 | Experimental | Drug: [14C]-Lu AF11167, Drug: Lu AF11167 MR tablet prototype formulation selected from part A or 1 mg modified release tablet (reference formulation)Treatment period 1: High-fat meal; Treatment period 2: Fasted + iv; Treatment period 3: Fasted |
| Part B group 3 | Experimental | Drug: [14C]-Lu AF11167, Drug: Lu AF11167 MR tablet prototype formulation selected from part A or 1 mg modified release tablet (reference formulation)Treatment period 1: Fasted; Treatment period 2: High-fat meal; Treatment period 3: Fasted + iv |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index (BMI) of ≥18.5 and ≤30.0 kg/m2
- (Part B only) Women of child-bearing potential will have a confirmed non-pregnant and non-lactating status
Key exclusion criteria (2 listed)
- The subject has any concurrent disorder that may affect the particular target or absorption, distribution, or elimination of the investigational medical product
- Other in- 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 |
|---|---|---|
| Lu AF11167Lu AF11167 - 2 mg modified release tablets (reference formulation), up to 5 prototype MR tablet formulations (test formulations) | Drug | Part A |
| [14C]-Lu AF11167single iv microdose administered as a 15 minutes infusion | Drug | Part B group 1, Part B group 2, Part B group 3 |
| Lu AF11167 MR tablet prototype formulation selected from part A or 1 mg modified release tablet (reference formulation)Single oral dose | Drug | Part B group 1, Part B group 2, Part B group 3 |
Primary outcome
Cmax of Lu AF11167
Time frame: From 0 to 48 hours
Maximum observed plasma concentration
AUC(0-inf) of Lu AF11167
Time frame: From 0 to 48 hours
Area under the plasma concentration time curve from zero to infinity
Relative bioavailability F(rel) of Lu AF11167
Time frame: From 0 to 48 hours
F(rel) is estimated as the dose normalized AUC(inf) for the test formulation relative to the reference formulation (part A only)
Absolute bioavailability F(abs) of Lu AF11167
Time frame: From 0 to 48 hours
F(abs) is estimated as the dose normalized AUC(inf) for the test formulation relative to the intravenous reference formulation (part B only)
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 17 Apr 2020.
- Individual participant dataSharing planned: Undecided
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
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 AF11167, [14C]-Lu AF11167 and Lu AF11167 MR tablet prototype formulation selected from part A or 1 mg modified release tablet (reference formulation) 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 2 inclusion and 2 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 17 Apr 2020. 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. 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?
Cmax of Lu AF11167 (time frame: From 0 to 48 hours). The study lists 4 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 17 Apr 2020.