Healthy MenPhase 1NCT02093169
D2 Dopamine Receptor Occupancy After Oral Dosing of Lu AF35700 in Healthy Men Using [11C]-PHNO as Tracer Compound
A Phase 1 study testing Part A: Lu AF35700 and Part B: Lu AF35700 in people with Healthy Men, run by H. Lundbeck A/S at 1 site in United Kingdom.
Trial summary
To investigate the relationship between the combined Lu AF35700 and Lu AF36152 plasma concentration and D2 dopamine receptor occupancy up to 172 hours after oral dosing of Lu AF35700 Read more about this study
- Who is it for?
- Ages 25 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Men
- What is being tested?
- Part A: Lu AF35700 and Part B: Lu AF35700
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2014to Jun 2014
- 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 25 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy young men >=25 and <=45 years of age with a Body Mass Index (BMI) >=18.5 kg/m2 and <=30 kg/m2.
- Other protocol-defined Inclusion 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, Positron Emission Tomography (PET) Study Investigating D2 Dopamine Receptor Occupancy After Oral Dosing of Lu AF35700 in Healthy Men Using [11C]-PHNO as Tracer Compound
To investigate the relationship between the combined Lu AF35700 and Lu AF36152 plasma concentration and D2 dopamine receptor occupancy up to 172 hours after oral dosing of Lu AF35700
- Conditions
- Healthy Men
- Being tested
- Part A: Lu AF35700, Part B: Lu AF35700
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Part A: Lu AF35700Drug
One 30 mg single dose for one day; orally
Part B: Lu AF35700Drug
Daily dosing: 10 mg for 3 days, 20 mg for 3 days, 45 mg on Day 7; orally
| Study group | Role | What they receive |
|---|---|---|
| Part A: Lu AF35700 | Experimental | Not described Receives: Drug: Part A: Lu AF35700 |
| Part B: Lu AF35700 | Experimental | Not described Receives: Drug: Part B: Lu AF35700 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between plasma concentrations and pharmacodynamic (PD) measures specified as binding potential at each scanning time point
Measured: Up to 172 hours after dosing
Relationship between plasma concentrations and PD measures specified as plasma concentrations of Lu AF35700, Lu AF36152 and Lu AF35700 + Lu AF36152 at each scanning time point
Measured: Up to 172 hours after dosing
Relationship between plasma concentrations and PD measures specified as occupancy in relation to plasma concentrations of Lu AF35700, Lu AF36152 and Lu AF35700 + Lu AF36152, respectively
Measured: Up to 172 hours after dosing
Secondary outcomes (3)
Adverse events
Measured: Up to Week 12
Columbia Suicide Severity Rating Scale (C-SSRS) (Part B only)
Measured: Up to Week 12
Area under the curve (AUC), maximum observed concentration (Cmax), oral clearance (CL/F), and apparent elimination half-life (t½)
Measured: Up to 168 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy MenStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT02093169
- Sponsor's protocol ID
- 15868A
- Other IDs
- 2013-004283-61
- Status last verified
- Sep 2014
- First submitted
- 19 Mar 2014
- Last updated
- 23 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Open-label, Positron Emission Tomography (PET) Study Investigating D2 Dopamine Receptor Occupancy After Oral Dosing of Lu AF35700 in Healthy Men Using [11C]-PHNO as Tracer Compound
- ClinicalTrials.gov ID
- NCT02093169
- Acronym / sponsor ID
- 15868A
- Conditions
- Healthy Men
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Jun 2014 (actual)
- First posted
- 20 Mar 2014 (estimated)
- 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.
To investigate the relationship between the combined Lu AF35700 and Lu AF36152 plasma concentration and D2 dopamine receptor occupancy up to 172 hours after oral dosing of Lu AF35700
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: Lu AF35700 | Experimental | Drug: Part A: Lu AF35700 |
| Part B: Lu AF35700 | Experimental | Drug: Part B: Lu AF35700 |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy young men >=25 and <=45 years of age with a Body Mass Index (BMI) >=18.5 kg/m2 and <=30 kg/m2.
- Other protocol-defined Inclusion 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 |
|---|---|---|
| Part A: Lu AF35700One 30 mg single dose for one day; orally | Drug | Part A: Lu AF35700 |
| Part B: Lu AF35700Daily dosing: 10 mg for 3 days, 20 mg for 3 days, 45 mg on Day 7; orally | Drug | Part B: Lu AF35700 |
Primary outcome
Relationship between plasma concentrations and pharmacodynamic (PD) measures specified as binding potential at each scanning time point
Time frame: Up to 172 hours after dosing
Relationship between plasma concentrations and PD measures specified as plasma concentrations of Lu AF35700, Lu AF36152 and Lu AF35700 + Lu AF36152 at each scanning time point
Time frame: Up to 172 hours after dosing
Relationship between plasma concentrations and PD measures specified as occupancy in relation to plasma concentrations of Lu AF35700, Lu AF36152 and Lu AF35700 + Lu AF36152, respectively
Time frame: Up to 172 hours after dosing
3 secondary outcomes
Adverse events
Time frame: Up to Week 12
Columbia Suicide Severity Rating Scale (C-SSRS) (Part B only)
Time frame: Up to Week 12
Area under the curve (AUC), maximum observed concentration (Cmax), oral clearance (CL/F), and apparent elimination half-life (t½)
Time frame: Up to 168 hours after dosing
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 23 Sep 2014.
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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 Part A: Lu AF35700 and Part B: Lu AF35700 in people with Healthy Men, 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 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 23 Sep 2014. 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?
Relationship between plasma concentrations and pharmacodynamic (PD) measures specified as binding potential at each scanning time point (time frame: Up to 172 hours after dosing). 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 23 Sep 2014.