Renal ImpairmentPhase 1NCT01934166
Pharmacokinetic Properties of Nalmefene in Subjects With Renal Impairment and in Healthy Subjects
A Phase 1 study testing Nalmefene 18 mg in people with Renal Impairment, run by H. Lundbeck A/S at 1 site in Germany.
Trial summary
To investigate if renal impairment will have an impact on the pharmacokinetics of nalmefene Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment
- What is being tested?
- Nalmefene 18 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2013to Aug 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy young subjects and subjects with renal impairment with a Glomerular Filtration Rate (GFR) of 50-80 ml/min/1.73m2, 30-<50 ml/min/1.73m2, <30 ml/min/1.73m2 will be included in the study.
- The subjects must have a BMI between 19 and 32 kg/m2.
Who cannot join
- The subject has a history of renal transplant or is undergoing dialyse treatment.
- The subject is, in the opinion of the investigator, unlikely to comply with the protocol or is unsuitable for any reason.
- Other inclusion and exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Interventional, Single-site, Open-label, Four-group, Single-dose Study Investigating the Pharmacokinetic Properties of Nalmefene in Subjects With Renal Impairment (Mild, Moderate, or Severe) and in Healthy Subjects
To investigate if renal impairment will have an impact on the pharmacokinetics of nalmefene
- Conditions
- Renal Impairment
- Being tested
- Nalmefene 18 mg
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nalmefene 18 mgDrug
Also called Selincro®
One single oral dose of 18 mg
| Study group | Role | What they receive |
|---|---|---|
| Nalmefene 18 mg | Experimental | 18 mg nalmefene corresponds to 20 mg nalmefene hydrochloride Receives: Drug: Nalmefene 18 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
For nalmefene and the metabolite nalmefene 3-O-glucuronide: area under the plasma concentration-time curve from zero to infinity (AUC0-inf)
Measured: Up to 120 hours post-dose
For nalmefene and the metabolite nalmefene 3-O-glucuronide: area under the plasma concentration-time curve from zero to time t (t being the time for last quantifiable concentration) (AUC0-t)
Measured: Up to 120 hours post-dose
For nalmefene and the metabolite nalmefene 3-O-glucuronide: maximum observed concentration (Cmax)
Measured: Up to 120 hours post-dose
For nalmefene and the metabolite nalmefene 3-O-glucuronide: nominal time corresponding to the occurrence of Cmax (tmax)
Measured: Up to 120 hours post-dose
For nalmefene and the metabolite nalmefene 3-O-glucuronide: apparent elimination half life in plasma (t½)
Measured: Up to 120 hours post-dose
For nalmefene and the metabolite nalmefene 3-O-glucuronide: renal Clearance (CLR)
Measured: Up to 120 hours post-dose
For nalmefene: oral clearance for nalmefene defined as dose/AUC0-inf (CL/F)
Measured: Up to 120 hours post-dose
For nalmefene: apparent volume of distribution for nalmefene (Vz /F)
Measured: Up to 120 hours post-dose
For the metabolite nalmefene 3-O-glucuronide: metabolic ratio (MR) defined as AUC0-inf,metabolite/AUC0-inf,parent
Measured: Up to 120 hours post-dose
Secondary outcomes (1)
Safety and tolerability
Number of adverse events
Measured: Up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2013 (estimated)
- Study startJul 2013
- Primary completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ImpairmentStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 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
- NCT01934166
- Sponsor's protocol ID
- 15084A
- Other IDs
- 2012-005711-53
- Status last verified
- Nov 2016
- First submitted
- 22 Aug 2013
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interventional, Single-site, Open-label, Four-group, Single-dose Study Investigating the Pharmacokinetic Properties of Nalmefene in Subjects With Renal Impairment (Mild, Moderate, or Severe) and in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01934166
- Acronym / sponsor ID
- 15084A
- Conditions
- Renal Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Aug 2014 (actual)
- First posted
- 4 Sep 2013 (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 if renal impairment will have an impact on the pharmacokinetics of nalmefene
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nalmefene 18 mg | Experimental | Drug: Nalmefene 18 mg18 mg nalmefene corresponds to 20 mg nalmefene hydrochloride |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy young subjects and subjects with renal impairment with a Glomerular Filtration Rate (GFR) of 50-80 ml/min/1.73m2, 30-<50 ml/min/1.73m2, <30 ml/min/1.73m2 will be included in the study.
- The subjects must have a BMI between 19 and 32 kg/m2.
Key exclusion criteria (3 listed)
- The subject has a history of renal transplant or is undergoing dialyse treatment.
- The subject is, in the opinion of the investigator, unlikely to comply with the protocol or is unsuitable for any reason.
- 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 |
|---|---|---|
| Nalmefene 18 mgAlso: Selincro®One single oral dose of 18 mg | Drug | Nalmefene 18 mg |
Primary outcome
For nalmefene and the metabolite nalmefene 3-O-glucuronide: area under the plasma concentration-time curve from zero to infinity (AUC0-inf)
Time frame: Up to 120 hours post-dose
For nalmefene and the metabolite nalmefene 3-O-glucuronide: area under the plasma concentration-time curve from zero to time t (t being the time for last quantifiable concentration) (AUC0-t)
Time frame: Up to 120 hours post-dose
For nalmefene and the metabolite nalmefene 3-O-glucuronide: maximum observed concentration (Cmax)
Time frame: Up to 120 hours post-dose
For nalmefene and the metabolite nalmefene 3-O-glucuronide: nominal time corresponding to the occurrence of Cmax (tmax)
Time frame: Up to 120 hours post-dose
For nalmefene and the metabolite nalmefene 3-O-glucuronide: apparent elimination half life in plasma (t½)
Time frame: Up to 120 hours post-dose
For nalmefene and the metabolite nalmefene 3-O-glucuronide: renal Clearance (CLR)
Time frame: Up to 120 hours post-dose
For nalmefene: oral clearance for nalmefene defined as dose/AUC0-inf (CL/F)
Time frame: Up to 120 hours post-dose
For nalmefene: apparent volume of distribution for nalmefene (Vz /F)
Time frame: Up to 120 hours post-dose
For the metabolite nalmefene 3-O-glucuronide: metabolic ratio (MR) defined as AUC0-inf,metabolite/AUC0-inf,parent
Time frame: Up to 120 hours post-dose
1 secondary outcome
Safety and tolerability
Time frame: Up to 10 days
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 8 Nov 2016.
Related trials for Renal Impairment
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
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 Nalmefene 18 mg in people with Renal Impairment, 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 2 inclusion and 3 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 8 Nov 2016. 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?
For nalmefene and the metabolite nalmefene 3-O-glucuronide: area under the plasma concentration-time curve from zero to infinity (AUC0-inf) (time frame: Up to 120 hours post-dose). The study lists 9 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 8 Nov 2016.