Alzheimer DiseasePhase 1NCT02340195
Pharmacokinetic Properties of Idalopirdine (Lu AE58054) in Subjects With and Without Impaired Kidney Function
A Phase 1 study testing Idalopirdine (Lu AE58054) 60 mg in people with Alzheimer Disease, run by H. Lundbeck A/S at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics properties of idalopirdine following multiple dosing in patients with renal impairment and compare to those in healthy subjects Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Idalopirdine (Lu AE58054) 60 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2015to Sep 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or women aged between 50 and 75 years (inclusive)
- BMI ≥18.5 kg/m2 and ≤32 kg/m2 at the Screening Visit.
- Group A: Patients with severe renal impairment renal impairment (creatinine clearance (ClCr) ≤29 mL/min)
- Group B: Healthy subjects with normal kidney function (creatinine clearance (ClCr) ≥90 mL/min, inclusive)
- Group C: Patients with moderate renal impairment ((creatinine clearance between 30 - 59 mL/min, inclusive)
- Group D: Patients with mild renal impairment (Creatinine clearance between 60 - 89 mL/min, inclusive)
Who cannot join
- •The subject has taken disallowed medication <1 week prior to the first dose of IMP or <5 half-lives prior to the first dose of IMP for any disallowed medication taken, whichever is longer)
- Other protocol defined inclusion and exclusion criteria do apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventional, Single-site, Open-label, Reduced/Staged, Multiple-dose Study Investigating the Pharmacokinetic Properties of Idalopirdine (Lu AE58054) in Patients With Renal Impairment and in Healthy Subjects
The purpose of this study is to evaluate the pharmacokinetics properties of idalopirdine following multiple dosing in patients with renal impairment and compare to those in healthy subjects
- Conditions
- Alzheimer Disease
- Being tested
- Idalopirdine (Lu AE58054) 60 mg
- Keywords
- Kidney impairment
- Medical subject headings
- Alzheimer Disease, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Idalopirdine (Lu AE58054) 60 mgDrug
encapsulated film-coated tablets for oral use once daily for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Idalopirdine (Lu AE58054) 60 mg (Group A) | Experimental | 8 patients with severe renal impairment and not on dialysis Receives: Drug: Idalopirdine (Lu AE58054) 60 mg |
| Idalopirdine (Lu AE58054) 60 mg (Group B) | Experimental | 8 healthy subjects Receives: Drug: Idalopirdine (Lu AE58054) 60 mg |
| Idalopirdine (Lu AE58054) 60 mg (Group C) | Experimental | Group C will not be tested, if severe renal impairment does not alter the pharmacokinetics to a clinically relevant extent, based on results from group A and B
8 patients with moderate renal impairment Receives: Drug: Idalopirdine (Lu AE58054) 60 mg |
| Idalopirdine (Lu AE58054) 60 mg (Group D) | Experimental | Group D will not be tested, if severe renal impairment does not alter the pharmacokinetics to a clinically relevant extent, based on results from group A and B
8 patients with mild renal impairment Receives: Drug: Idalopirdine (Lu AE58054) 60 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the LuAE58054 plasma concentration-time curve from time zero to 24h(AUC0-24)
Measured: Day 10
Maximum observed concentration (Cmax) of Lu AE58054
Measured: 0-12 hours day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02340195
- Sponsor's protocol ID
- 14916A
- Other IDs
- 2012-005647-25
- Status last verified
- Nov 2015
- First submitted
- 13 Jan 2015
- Last updated
- 9 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Single-site, Open-label, Reduced/Staged, Multiple-dose Study Investigating the Pharmacokinetic Properties of Idalopirdine (Lu AE58054) in Patients With Renal Impairment and in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02340195
- Acronym / sponsor ID
- 14916A
- Conditions
- Alzheimer Disease
- Keywords
- Kidney impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Sep 2015 (actual)
- First posted
- 16 Jan 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 evaluate the pharmacokinetics properties of idalopirdine following multiple dosing in patients with renal impairment and compare to those in healthy subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Idalopirdine (Lu AE58054) 60 mg (Group A) | Experimental | Drug: Idalopirdine (Lu AE58054) 60 mg8 patients with severe renal impairment and not on dialysis |
| Idalopirdine (Lu AE58054) 60 mg (Group B) | Experimental | Drug: Idalopirdine (Lu AE58054) 60 mg8 healthy subjects |
| Idalopirdine (Lu AE58054) 60 mg (Group C) | Experimental | Drug: Idalopirdine (Lu AE58054) 60 mgGroup C will not be tested, if severe renal impairment does not alter the pharmacokinetics to a clinically relevant extent, based on results from group A and B 8 patients with moderate renal impairment |
| Idalopirdine (Lu AE58054) 60 mg (Group D) | Experimental | Drug: Idalopirdine (Lu AE58054) 60 mgGroup D will not be tested, if severe renal impairment does not alter the pharmacokinetics to a clinically relevant extent, based on results from group A and B 8 patients with mild renal impairment |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men or women aged between 50 and 75 years (inclusive)
- BMI ≥18.5 kg/m2 and ≤32 kg/m2 at the Screening Visit.
- Group A: Patients with severe renal impairment renal impairment (creatinine clearance (ClCr) ≤29 mL/min)
- Group B: Healthy subjects with normal kidney function (creatinine clearance (ClCr) ≥90 mL/min, inclusive)
- Group C: Patients with moderate renal impairment ((creatinine clearance between 30 - 59 mL/min, inclusive)
Key exclusion criteria (2 listed)
- •The subject has taken disallowed medication <1 week prior to the first dose of IMP or <5 half-lives prior to the first dose of IMP for any disallowed medication taken, whichever is longer)
- 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 |
|---|---|---|
| Idalopirdine (Lu AE58054) 60 mgencapsulated film-coated tablets for oral use once daily for 10 days | Drug | Idalopirdine (Lu AE58054) 60 mg (Group A), Idalopirdine (Lu AE58054) 60 mg (Group B), Idalopirdine (Lu AE58054) 60 mg (Group C), Idalopirdine (Lu AE58054) 60 mg (Group D) |
Primary outcome
Area under the LuAE58054 plasma concentration-time curve from time zero to 24h(AUC0-24)
Time frame: Day 10
Maximum observed concentration (Cmax) of Lu AE58054
Time frame: 0-12 hours day 10
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 9 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Idalopirdine (Lu AE58054) 60 mg in people with Alzheimer Disease, run by H. Lundbeck A/S at 1 site in Germany.
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 6 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 9 Nov 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 Germany. 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?
Area under the LuAE58054 plasma concentration-time curve from time zero to 24h(AUC0-24) (time frame: Day 10). 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 9 Nov 2015.