Heptic ImpairmentPhase 1NCT02231450
Pharmacokinetics Properties of Single Oral Dosing of Lu AE58054 in Subjects With Hepatic Impairment (Mild and Moderate) and in Healthy Subjects
A Phase 1 study testing Lu AE58054 encapsulated film-coated tablets in people with Heptic Impairment, run by H. Lundbeck A/S at 1 site in Germany.
Trial summary
The purpose of this study is to assess the impact of mild to moderate hepatic impairment on the pharmacokinetics of Lu AE58054 following a single oral dose of Lu AE58054 Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Heptic Impairment
- What is being tested?
- Lu AE58054 encapsulated film-coated tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2014to Mar 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged between 40 and 65 years (inclusive) with a body mass index between 19 and 32 kg/m2 (inclusive).
- Group 1: Patients with mild hepatic impairment (Child-Pugh's Criteria A, score 5-6)
- Group 2: Patients with moderate hepatic impairment (Child-Pugh's Criteria B, score 7-9)
- Group 3: Healthy subjects with normal hepatic function
- Other pre-defined inclusion and exclusion criteria may apply.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventional, Open-label, Three-group Study to Determine the Pharmacokinetic Properties of Single Oral Dosing of Lu AE58054 in Patients With Hepatic Impairment (Mild and Moderate) and in Healthy Subjects
The purpose of this study is to assess the impact of mild to moderate hepatic impairment on the pharmacokinetics of Lu AE58054 following a single oral dose of Lu AE58054
- Conditions
- Heptic Impairment
- Being tested
- Lu AE58054 encapsulated film-coated tablets
- Keywords
- AE58054, Hepatic impairment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AE58054 encapsulated film-coated tabletsDrug
| Study group | Role | What they receive |
|---|---|---|
| Patients with mild hepatic impairment (Group1) | Experimental | 8 patients with mild hepatic impairment will be administered a single oral dose of 60 mg Lu AE58054 Receives: Drug: Lu AE58054 encapsulated film-coated tablets |
| Patients with moderate hepatic impairment (Group 2) | Experimental | 8 patients with moderate hepatic impairment will be administered a single oral dose of 60 mg Lu AE58054. Receives: Drug: Lu AE58054 encapsulated film-coated tablets |
| Healthy subjects (Group 3) | Experimental | 8 healthy subjects will be administered a single oral dose of 60 mg Lu AE58054. Receives: Drug: Lu AE58054 encapsulated film-coated tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the Lu AE58054 plasma concentration-time curve from time zero to infinity (AUC0-inf)
Measured: 0 to 96 hours
Maximum observed plasma concentration (Cmax) of Lu AE58054
Measured: 0 to 96 hours
Secondary outcomes (1)
Absolute values and changes from baseline in safety variables (Adverse events, clinical safety laboratory tests, vital signs, weight, and ECG)
Measured: Screening to day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2014 (estimated)
- Study startJul 2014
- Primary completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heptic 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT02231450
- Sponsor's protocol ID
- 15877A
- Other IDs
- 2013-004449-18
- Status last verified
- Mar 2015
- First submitted
- 1 Sep 2014
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Open-label, Three-group Study to Determine the Pharmacokinetic Properties of Single Oral Dosing of Lu AE58054 in Patients With Hepatic Impairment (Mild and Moderate) and in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02231450
- Acronym / sponsor ID
- 15877A
- Conditions
- Heptic Impairment
- Keywords
- AE58054, Hepatic impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Mar 2015 (actual)
- First posted
- 4 Sep 2014 (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 assess the impact of mild to moderate hepatic impairment on the pharmacokinetics of Lu AE58054 following a single oral dose of Lu AE58054
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with mild hepatic impairment (Group1) | Experimental | Drug: Lu AE58054 encapsulated film-coated tablets8 patients with mild hepatic impairment will be administered a single oral dose of 60 mg Lu AE58054 |
| Patients with moderate hepatic impairment (Group 2) | Experimental | Drug: Lu AE58054 encapsulated film-coated tablets8 patients with moderate hepatic impairment will be administered a single oral dose of 60 mg Lu AE58054. |
| Healthy subjects (Group 3) | Experimental | Drug: Lu AE58054 encapsulated film-coated tablets8 healthy subjects will be administered a single oral dose of 60 mg Lu AE58054. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women aged between 40 and 65 years (inclusive) with a body mass index between 19 and 32 kg/m2 (inclusive).
- Group 1: Patients with mild hepatic impairment (Child-Pugh's Criteria A, score 5-6)
- Group 2: Patients with moderate hepatic impairment (Child-Pugh's Criteria B, score 7-9)
- Group 3: Healthy subjects with normal hepatic function
- Other pre-defined inclusion and exclusion criteria may apply.
Key exclusion criteria (0 listed)
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 AE58054 encapsulated film-coated tablets | Drug | Healthy subjects (Group 3), Patients with mild hepatic impairment (Group1), Patients with moderate hepatic impairment (Group 2) |
Primary outcome
Area under the Lu AE58054 plasma concentration-time curve from time zero to infinity (AUC0-inf)
Time frame: 0 to 96 hours
Maximum observed plasma concentration (Cmax) of Lu AE58054
Time frame: 0 to 96 hours
1 secondary outcome
Absolute values and changes from baseline in safety variables (Adverse events, clinical safety laboratory tests, vital signs, weight, and ECG)
Time frame: Screening to day 11
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 18 Mar 2015.
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 AE58054 encapsulated film-coated tablets in people with Heptic 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 5 inclusion and 0 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 18 Mar 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 Lu AE58054 plasma concentration-time curve from time zero to infinity (AUC0-inf) (time frame: 0 to 96 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 18 Mar 2015.