HealthyPhase 1NCT03670082
Study With Lu AF35700 in Healthy Men and Women in Fasting and Fed State
A Phase 1 study testing Lu AF35700 and Lu AF35700 iv 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 AF35700 enters the bloodstream following pill intake and the influence of food on the 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 AF35700 and Lu AF35700 iv
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Sep 2018to 13 Jan 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women aged ≥18 and ≤55 years
- Body Mass Index (BMI) of ≥18.5 and ≤30 kg/m2
- Subject must be in good general health as assessed using medical history, clinical laboratory tests, and physical examination
Who cannot join
- The subject must not be of childbearing potential (if a woman) or should use contraception, be surgically sterilized or not be sexually active (both sexes). Women must not be pregnant or lactating
- The subject must not be a CYP2D6 or a CYP2C19 poor metabolizer
- Other inclusion and exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventional, Open-label, Two-way Crossover, Single-dose Study Investigating the Absolute Bioavailability and Food Effect on the Pharmacokinetics of Lu AF35700 in Healthy Subjects
The purpose of this study is to investigate the extent to which Lu AF35700 enters the bloodstream following pill intake and the influence of food on the uptake in healthy men and women
Read the detailed description
Each subject will receive a single oral dose of Lu AF35700 on Day 1 in each Period. Subjects in Group 1 will be in fasting condition in Period I and in a fed condition in Period II. Subjects in Group 2 will be in fed condition in Period I and in fasting condition in Period II.
For Group 1, period 1 only, a single intravenous micro-dose of Lu AF35700 will be given 4 hours after oral dosing.
All subjects will be confined to the clinic from one day prior to the first dosing until Day 6 (120 hours post dose) for each dosing period. Periods I and II will be separated by a period of 6 weeks.
- Conditions
- Healthy
- Being tested
- Lu AF35700, Lu AF35700 iv
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AF35700Drug
20 mg Lu AF35700 single oral dose
Lu AF35700 ivDrug
100 μg [14C]-Lu AF35700 (4.7 μCi/174 kBq) single intravenous micro-dose
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Fasting condition in Period I | Experimental | Subjects will be in fasting condition in Period I and in a fed condition in Period II. Receives: Drug: Lu AF35700; Drug: Lu AF35700 iv |
| Group 2: Fed condition in Period I | Experimental | Subjects will be in fed condition in Period I and in fasting condition in Period II. Receives: Drug: Lu AF35700 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute bioavailability Fabs
Fabs= 100*(AUC0-72h, po*Div) / (AUC0-72h, iv*Dpo) (where D is the dose)
Measured: 0 to 120 hours
Secondary outcomes (3)
AUC0-inf: area under the Lu AF35700 plasma concentration-time curve from zero to 72 hours
Area under the plasma concentration-time curve from zero to 72 hours for Lu AF35700
Measured: 0 to 120 hours
Cmax: maximum observed plasma concentration
Maximum observed plasma concentration of Lu AF35700
Measured: 0 to 120 hours
tmax: time at maximum observed plasma concentration
Time at which maximum observed plasma concentration of Lu AF35700 occurred
Measured: 0 to 120 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start5 Sep 2018
- Primary completion21 Dec 2018
- Study completion13 Jan 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT03670082
- Sponsor's protocol ID
- 17482A
- Status last verified
- Oct 2019
- First submitted
- 12 Sep 2018
- Last updated
- 1 Nov 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 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Open-label, Two-way Crossover, Single-dose Study Investigating the Absolute Bioavailability and Food Effect on the Pharmacokinetics of Lu AF35700 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03670082
- Acronym / sponsor ID
- 17482A
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2018 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 13 Jan 2019 (actual)
- First posted
- 13 Sep 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 the extent to which Lu AF35700 enters the bloodstream following pill intake and the influence of food on the uptake in healthy men and women
Detailed description
Each subject will receive a single oral dose of Lu AF35700 on Day 1 in each Period. Subjects in Group 1 will be in fasting condition in Period I and in a fed condition in Period II. Subjects in Group 2 will be in fed condition in Period I and in fasting condition in Period II.
For Group 1, period 1 only, a single intravenous micro-dose of Lu AF35700 will be given 4 hours after oral dosing.
All subjects will be confined to the clinic from one day prior to the first dosing until Day 6 (120 hours post dose) for each dosing period. Periods I and II will be separated by a period of 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Fasting condition in Period I | Experimental | Drug: Lu AF35700, Drug: Lu AF35700 ivSubjects will be in fasting condition in Period I and in a fed condition in Period II. |
| Group 2: Fed condition in Period I | Experimental | Drug: Lu AF35700Subjects will be in fed condition in Period I and in fasting condition in Period II. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy men and women aged ≥18 and ≤55 years
- Body Mass Index (BMI) of ≥18.5 and ≤30 kg/m2
- Subject must be in good general health as assessed using medical history, clinical laboratory tests, and physical examination
Key exclusion criteria (3 listed)
- The subject must not be of childbearing potential (if a woman) or should use contraception, be surgically sterilized or not be sexually active (both sexes). Women must not be pregnant or lactating
- The subject must not be a CYP2D6 or a CYP2C19 poor metabolizer
- 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 |
|---|---|---|
| Lu AF3570020 mg Lu AF35700 single oral dose | Drug | Group 1: Fasting condition in Period I, Group 2: Fed condition in Period I |
| Lu AF35700 iv100 μg [14C]-Lu AF35700 (4.7 μCi/174 kBq) single intravenous micro-dose | Drug | Group 1: Fasting condition in Period I |
Primary outcome
Absolute bioavailability Fabs
Time frame: 0 to 120 hours
Fabs= 100*(AUC0-72h, po*Div) / (AUC0-72h, iv*Dpo) (where D is the dose)
3 secondary outcomes
AUC0-inf: area under the Lu AF35700 plasma concentration-time curve from zero to 72 hours
Time frame: 0 to 120 hours
Cmax: maximum observed plasma concentration
Time frame: 0 to 120 hours
tmax: time at maximum observed plasma concentration
Time frame: 0 to 120 hours
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 1 Nov 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 AF35700 and Lu AF35700 iv 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 3 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 1 Nov 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. 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?
Absolute bioavailability Fabs (time frame: 0 to 120 hours). 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 1 Nov 2019.