HealthyPhase 1FoligluraxNCT04002895
What the Body Does to Foliglurax in Healthy Volunteers
A Phase 1 study testing Foliglurax in people with Healthy, run by H. Lundbeck A/S at 1 site in United Kingdom.
Trial summary
This study evaluates how the body takes up and gets rid of foliglurax after swallowing a liquid dose. Read more about this study
- Who is it for?
- Ages 45 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Foliglurax
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Jun 2019to 8 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 45 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men with a body mass index (BMI) of 19-30 kg/m2 (inclusive), and with a body weight of minimum 60 kg 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.
- Other inclusion and exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventional, Open-label, Single-dose Study Investigating the Absorption, Metabolism and Excretion (AME) of Foliglurax (Lu AF99757) Following Oral Dosing of 14C-foliglurax to Healthy Men
This study evaluates how the body takes up and gets rid of foliglurax after swallowing a liquid dose.
Read the detailed description
Six healthy men will swallow a liquid dose of 80 mg that is labelled with a small dose of radioactive tracer. Blood, urine and faeces will be collected to measure how much of the radioactivity gets into the blood stream and ends up in the urine and faeces. It is also measured how the body gets rid of the radioactivity and how quickly.
- Conditions
- Healthy
- Being tested
- Foliglurax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FoligluraxDrug
Single oral dose of 80 mg [14C]-foliglurax(93µCi/3.44 MBq), 1mg/mL oral solution (prepared from [14C]-foliglurax powder for oral solution)
| Study group | Role | What they receive |
|---|---|---|
| Foliglurax | Experimental | Not described Receives: Drug: Foliglurax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount of radioactivity excreted
Cumulative amount of radioactivity excreted in urine and faeces
Measured: Before dosing until day 11
AUC(0-inf) foliglurax
Area under the plasma concentration time curve from zero to infinity
Measured: From day 1 until day 11
Cmax foliglurax
Maximum observed plasma concentration
Measured: From day 1 until day 11
CL/F foliglurax
Oral clearance for foliglurax in plasma
Measured: From Day 1 until Day 11
Total recovery of the administered dose
% of dose in urine and faeces
Measured: Before dosing until day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start27 Jun 2019
- Primary completion1 Aug 2019
- Study completion8 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
- 6 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
- NCT04002895
- Sponsor's protocol ID
- 18154A
- Acronym
- Foliglurax
- Status last verified
- Nov 2019
- First submitted
- 27 Jun 2019
- Last updated
- 4 Nov 2019
- 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 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Open-label, Single-dose Study Investigating the Absorption, Metabolism and Excretion (AME) of Foliglurax (Lu AF99757) Following Oral Dosing of 14C-foliglurax to Healthy Men
- ClinicalTrials.gov ID
- NCT04002895
- Acronym / sponsor ID
- Foliglurax / 18154A
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2019 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 8 Aug 2019 (actual)
- First posted
- 1 Jul 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.
This study evaluates how the body takes up and gets rid of foliglurax after swallowing a liquid dose.
Detailed description
Six healthy men will swallow a liquid dose of 80 mg that is labelled with a small dose of radioactive tracer. Blood, urine and faeces will be collected to measure how much of the radioactivity gets into the blood stream and ends up in the urine and faeces. It is also measured how the body gets rid of the radioactivity and how quickly.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Foliglurax | Experimental | Drug: Foliglurax |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy men with a body mass index (BMI) of 19-30 kg/m2 (inclusive), and with a body weight of minimum 60 kg at the Screening Visit.
Key exclusion criteria (2 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.
- 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 |
|---|---|---|
| FoligluraxSingle oral dose of 80 mg [14C]-foliglurax(93µCi/3.44 MBq), 1mg/mL oral solution (prepared from [14C]-foliglurax powder for oral solution) | Drug | Foliglurax |
Primary outcome
Total amount of radioactivity excreted
Time frame: Before dosing until day 11
Cumulative amount of radioactivity excreted in urine and faeces
AUC(0-inf) foliglurax
Time frame: From day 1 until day 11
Area under the plasma concentration time curve from zero to infinity
Cmax foliglurax
Time frame: From day 1 until day 11
Maximum observed plasma concentration
CL/F foliglurax
Time frame: From Day 1 until Day 11
Oral clearance for foliglurax in plasma
Total recovery of the administered dose
Time frame: Before dosing until day 11
% of dose in urine and faeces
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 4 Nov 2019.
- Individual participant dataSharing planned: Undecided
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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 Foliglurax 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 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 4 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?
Total amount of radioactivity excreted (time frame: Before dosing until day 11). The study lists 5 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 4 Nov 2019.