HealthyPhase 1NCT02415907
Investigating the Absorption, Metabolism and Excretion (AME) of Idalopirdine
A Phase 1 study testing [ethyl-1-14C]-idalopirdine and [benzyl-7-14C]-idalopirdine 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 investigating the absorption, metabolism and excretion of radio labelled single doses of idalopirdine in healthy men. Read more about this study
- Who is it for?
- Ages 40 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- [ethyl-1-14C]-idalopirdine and [benzyl-7-14C]-idalopirdine
- 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
- Apr 2015to Jun 2015
- 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 40 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men
- aged between 40-60 years (inclusive)
- BMI in the range 19 and 30 kg/m2 (minimum weight 60 kg)
Who cannot join
- The subject has previously been dosed with idalopirdine.
- Other protocol defined inclusion and exclusion criteria do apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventional, Open-label, Two Single Dose, Fixed-sequence Study Investigating the Absorption, Metabolism and Excretion (AME) of Idalopirdine Following a Single Oral Dose of Lu AF67708 ([Ethyl-1-14C]-Idalopirdine) and Lu AF67709 ([Benzyl-7-14C]-Idalopirdine) in Healthy Men
The purpose of this study is to investigating the absorption, metabolism and excretion of radio labelled single doses of idalopirdine in healthy men.
- Conditions
- Healthy
- Being tested
- [ethyl-1-14C]-idalopirdine, [benzyl-7-14C]-idalopirdine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[ethyl-1-14C]-idalopirdineDrug
Also called Lu AF67708
120 mg/2.40 MBq Lu AF67708 ([ethyl-1-14C]-idalopirdine) in one capsule for oral administration, single dose
[benzyl-7-14C]-idalopirdineDrug
Also called Lu AF67709
120 mg/2.40 MBq Lu AF67709 ([benzyl-7-14C]-idalopirdine) in one capsule for oral administration, single dose
| Study group | Role | What they receive |
|---|---|---|
| Idalopirdine | Experimental | Period I: Initial administration of Lu AF67709 single dose at baseline.
Period II: Administration of Lu AF67708 single dose (week 4) Receives: Drug: [ethyl-1-14C]-idalopirdine; Drug: [benzyl-7-14C]-idalopirdine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative amounts of radioactivity excreted in urine and faeces (% of dose)
Measured: 0 to 168 hours
Pharmacokinetic (PK) of idalopirdine and radioactivity in plasma (Cmax, tmax, AUC, t1/2, oral clearance and apparant volume of distribution. (composite outcome measure)
PK parameter:
Measured: 0 to 168 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionJun 2015
- Study completionJun 2015
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, Study director, LuncbeckClinicalTrials@Lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02415907
- Sponsor's protocol ID
- 15836A
- Other IDs
- 2013-004001-28
- Status last verified
- Jul 2015
- First submitted
- 7 Apr 2015
- Last updated
- 20 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Open-label, Two Single Dose, Fixed-sequence Study Investigating the Absorption, Metabolism and Excretion (AME) of Idalopirdine Following a Single Oral Dose of Lu AF67708 ([Ethyl-1-14C]-Idalopirdine) and Lu AF67709 ([Benzyl-7-14C]-Idalopirdine) in Healthy Men
- ClinicalTrials.gov ID
- NCT02415907
- Acronym / sponsor ID
- 15836A
- 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
- Apr 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 14 Apr 2015 (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.
The purpose of this study is to investigating the absorption, metabolism and excretion of radio labelled single doses of idalopirdine in healthy men.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Idalopirdine | Experimental | Drug: [ethyl-1-14C]-idalopirdine, Drug: [benzyl-7-14C]-idalopirdinePeriod I: Initial administration of Lu AF67709 single dose at baseline. Period II: Administration of Lu AF67708 single dose (week 4) |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy men
- aged between 40-60 years (inclusive)
- BMI in the range 19 and 30 kg/m2 (minimum weight 60 kg)
Key exclusion criteria (2 listed)
- The subject has previously been dosed with idalopirdine.
- Other protocol defined inclusion and exclusion criteria do 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 |
|---|---|---|
| [ethyl-1-14C]-idalopirdineAlso: Lu AF67708120 mg/2.40 MBq Lu AF67708 ([ethyl-1-14C]-idalopirdine) in one capsule for oral administration, single dose | Drug | Idalopirdine |
| [benzyl-7-14C]-idalopirdineAlso: Lu AF67709120 mg/2.40 MBq Lu AF67709 ([benzyl-7-14C]-idalopirdine) in one capsule for oral administration, single dose | Drug | Idalopirdine |
Primary outcome
Cumulative amounts of radioactivity excreted in urine and faeces (% of dose)
Time frame: 0 to 168 hours
Pharmacokinetic (PK) of idalopirdine and radioactivity in plasma (Cmax, tmax, AUC, t1/2, oral clearance and apparant volume of distribution. (composite outcome measure)
Time frame: 0 to 168 hours
PK parameter:
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 20 Jul 2015.
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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 study director
LuncbeckClinicalTrials@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 [ethyl-1-14C]-idalopirdine and [benzyl-7-14C]-idalopirdine 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 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 20 Jul 2015. 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?
Cumulative amounts of radioactivity excreted in urine and faeces (% of dose) (time frame: 0 to 168 hours). The study lists 2 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 20 Jul 2015.