Hepatic ImpairmentPhase 1NCT03189615
Study Investigating the Pharmacokinetic Properties of the Drug Lu AF35700 in Subjects With Liver Impairment and in Healthy Subjects
A Phase 1 study testing Lu AF35700 in people with Hepatic 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 a single oral dose of Lu AF35700 Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- 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
- 24 participants
- Where
- 1 siteGermany
- Study dates
- 14 May 2017to 23 Apr 2018
- 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
- Subjects with hepatic impairment disease stage Child-Pugh's Criteria A (mild) or Child-Pugh's Criteria B (moderate) and healthy subjects with normal hepatic function
- Subjects have a body mass index between 18.5 and 34 kg/m2 (inclusive)
Who cannot join
- Subjects previously been dosed with Lu AF35700
- Other protocol defined inclusion and exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventional, Open-label, Three-group, Single-dose Study Investigating the Pharmacokinetic Properties of Lu AF35700 in Subjects With Hepatic Impairment (Mild or 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 a single oral dose of Lu AF35700
- Conditions
- Hepatic Impairment
- Being tested
- Lu AF35700
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AF35700Drug
Single oral dose of 10 mg Lu AF35700
| Study group | Role | What they receive |
|---|---|---|
| Patients with mild hepatic impairment (Group1) | Experimental | Not described Receives: Drug: Lu AF35700 |
| Patients with moderate hepatic impairment (Group 2) | Experimental | Not described Receives: Drug: Lu AF35700 |
| Healthy subjects (Group 3) | Experimental | Not described Receives: Drug: Lu AF35700 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the Lu AF35700 plasma concentration-time curve from zero to infinity (AUC0-inf)
Area under the Lu AF35700 plasma concentration-time curve from zero to infinity (AUC0-inf)
Measured: Predose to day 57 postdose
Maximum observed plasma concentration (Cmax) of Lu AF35700
Maximum observed plasma concentration (Cmax) 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 posted16 Jun 2017
- Study start14 May 2017
- Primary completion28 Feb 2018
- Study completion23 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic 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
- NCT03189615
- Sponsor's protocol ID
- 17256A
- Other IDs
- 2016-004139-20, 2016
- Status last verified
- May 2018
- First submitted
- 14 Jun 2017
- Last updated
- 4 May 2018
- 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 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Open-label, Three-group, Single-dose Study Investigating the Pharmacokinetic Properties of Lu AF35700 in Subjects With Hepatic Impairment (Mild or Moderate) and in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03189615
- Acronym / sponsor ID
- 17256A
- Conditions
- 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
- 14 May 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 23 Apr 2018 (actual)
- First posted
- 16 Jun 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.
The purpose of this study is to assess the impact of mild to moderate hepatic impairment on the pharmacokinetics of a single oral dose of Lu AF35700
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 AF35700 |
| Patients with moderate hepatic impairment (Group 2) | Experimental | Drug: Lu AF35700 |
| Healthy subjects (Group 3) | 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 (2 listed)
- Subjects with hepatic impairment disease stage Child-Pugh's Criteria A (mild) or Child-Pugh's Criteria B (moderate) and healthy subjects with normal hepatic function
- Subjects have a body mass index between 18.5 and 34 kg/m2 (inclusive)
Key exclusion criteria (2 listed)
- Subjects previously been dosed with Lu AF35700
- Other protocol defined 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 |
|---|---|---|
| Lu AF35700Single oral dose of 10 mg Lu AF35700 | Drug | Healthy subjects (Group 3), Patients with mild hepatic impairment (Group1), Patients with moderate hepatic impairment (Group 2) |
Primary outcome
Area under the Lu AF35700 plasma concentration-time curve from zero to infinity (AUC0-inf)
Time frame: Predose to day 57 postdose
Area under the Lu AF35700 plasma concentration-time curve from zero to infinity (AUC0-inf)
Maximum observed plasma concentration (Cmax) of Lu AF35700
Time frame: Predose to day 57 postdose
Maximum observed plasma concentration (Cmax) of Lu AF35700
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 4 May 2018.
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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 Hepatic 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 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 4 May 2018. 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 AF35700 plasma concentration-time curve from zero to infinity (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 4 May 2018.