Renal FailurePhase 1NCT03241147
Pharmacokinetics of Lu AF35700 in Subjects With Renal Impairment
A Phase 1 study testing Lu AF35700 in people with Renal Failure, run by H. Lundbeck A/S at 1 site in Germany.
Trial summary
This study will evaluate the pharmacokinetics of Lu AF35700 after a single dose tablet to subjects with renal impairment (kidney insufficiency) and compare that with healthy subjects Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Failure
- What is being tested?
- Lu AF35700
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteGermany
- Study dates
- 25 Jul 2017to 24 Jul 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -Healthy subjects: The subject has a Glomerular Filtration Rate as based on creatinine clearance (CLCr) ≥90 mL/min (estimated by the Cockcroft-Gault method)
- -Subjects with renal impairment: The subject has any form of renal dysfunction which includes polycystic kidney disease
- The subject is classified as having renal impairment at Screening according to Cockroft-Gault method for estimating creatinine clearance:
- Severe: CLCr ≤ 29 mL/min Moderate: 30 mL/min ≤ CLCr ≤ 59 mL/min Mild: 60 mL/min ≤ CLCr ≤ 89 mL/min
Who cannot join
- -The subject has previously been dosed with Lu AF35700
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventional, Open Label, Reduced/Staged, Single Dose Study Investigating the Pharmacokinetic Properties of Lu AF35700 in Subjects With Renal Impairment and in Healthy Subjects
This study will evaluate the pharmacokinetics of Lu AF35700 after a single dose tablet to subjects with renal impairment (kidney insufficiency) and compare that with healthy subjects
Read the detailed description
If the initial data shows a substantial effect in subjects with severe renal impairment, the study will be expanded to include subjects with intermediate level (mild and moderate) of renal impairment.
- Conditions
- Renal Failure
- Being tested
- Lu AF35700
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AF35700Drug
Single dose, 10 mg film coated tablet
| Study group | Role | What they receive |
|---|---|---|
| Subjects with severe renal impairment (Group A) | Experimental | Not described Receives: Drug: Lu AF35700 |
| Healthy subjects (Group B) | Experimental | Not described Receives: Drug: Lu AF35700 |
| Subjects with moderate renal impairment (Group C) | Experimental | Not described Receives: Drug: Lu AF35700 |
| Subjects with mild renal impairment (Group D) | Experimental | Not described Receives: Drug: Lu AF35700 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-inf
Area under the Lu AF35700 plasma concentration-time curve from zero to infinity
Measured: Predose to day 57 postdose
Cmax
Maximum observed plasma concentration of Lu AF35700
Measured: Predose to day 57 postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start25 Jul 2017
- Primary completion17 Jul 2019
- Study completion24 Jul 2019
Why it stopped: New data; the study was terminated based on new efficacy data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies 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
- 23 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
- NCT03241147
- Sponsor's protocol ID
- 17278A
- Status last verified
- Sep 2019
- First submitted
- 2 Aug 2017
- Last updated
- 30 Sep 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 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Open Label, Reduced/Staged, Single Dose Study Investigating the Pharmacokinetic Properties of Lu AF35700 in Subjects With Renal Impairment and in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03241147
- Acronym / sponsor ID
- 17278A
- Conditions
- Renal Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: New data; the study was terminated based on new efficacy data
- Enrolment
- 23 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 25 Jul 2017 (actual)
- Primary completion
- 17 Jul 2019 (actual)
- Study completion
- 24 Jul 2019 (actual)
- First posted
- 7 Aug 2017 (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 will evaluate the pharmacokinetics of Lu AF35700 after a single dose tablet to subjects with renal impairment (kidney insufficiency) and compare that with healthy subjects
Detailed description
If the initial data shows a substantial effect in subjects with severe renal impairment, the study will be expanded to include subjects with intermediate level (mild and moderate) of renal impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Subjects with severe renal impairment (Group A) | Experimental | Drug: Lu AF35700 |
| Healthy subjects (Group B) | Experimental | Drug: Lu AF35700 |
| Subjects with moderate renal impairment (Group C) | Experimental | Drug: Lu AF35700 |
| Subjects with mild renal impairment (Group D) | Experimental | Drug: Lu AF35700 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- -Healthy subjects: The subject has a Glomerular Filtration Rate as based on creatinine clearance (CLCr) ≥90 mL/min (estimated by the Cockcroft-Gault method)
- -Subjects with renal impairment: The subject has any form of renal dysfunction which includes polycystic kidney disease
- The subject is classified as having renal impairment at Screening according to Cockroft-Gault method for estimating creatinine clearance:
- Severe: CLCr ≤ 29 mL/min Moderate: 30 mL/min ≤ CLCr ≤ 59 mL/min Mild: 60 mL/min ≤ CLCr ≤ 89 mL/min
Key exclusion criteria (1 listed)
- -The subject has previously been dosed with Lu AF35700
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 AF35700Single dose, 10 mg film coated tablet | Drug | Healthy subjects (Group B), Subjects with mild renal impairment (Group D), Subjects with moderate renal impairment (Group C), Subjects with severe renal impairment (Group A) |
Primary outcome
AUC0-inf
Time frame: Predose to day 57 postdose
Area under the Lu AF35700 plasma concentration-time curve from zero to infinity
Cmax
Time frame: Predose to day 57 postdose
Maximum observed plasma concentration of Lu AF35700
Results and safety
The study was stopped early (reason given: New data; the study was terminated based on new efficacy data). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 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 in people with Renal Failure, 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 4 inclusion and 1 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: stopped early, as of the sponsor's last update on 30 Sep 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 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 was stopped early (reason given: New data; the study was terminated based on new efficacy data). Results are not available in the source record.
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?
AUC0-inf (time frame: Predose to day 57 postdose). 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 30 Sep 2019.