Hepatic ImpairmentPhase 1NCT01984736
EVP-6124 Hepatic Impairment Study
A Phase 1 study testing Experimental: EVP-6124 in people with Hepatic Impairment, run by FORUM Pharmaceuticals Inc at 3 sites in 3 countries.
Trial summary
The purpose of this study is to assess the pharmacokinetics of EVP-6124 and metabolites after a single oral dose in subjects with mild, moderate and severe hepatic impairment compared with subjects with normal hepatic function. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- Experimental: EVP-6124
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jun 2013to Dec 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult male or female subjects age 18 to 65 years (both inclusive).
- Able to understand and willing to sign the Informed Consent Form and able to comply with the study restrictions.
- Females may enroll if they are:
- documented to be surgically sterile or postmenopausal (amenorrhoea greater than 1 year and follicle stimulating hormone,FSH, greater than or equal to 30 mU/mL), or
- practicing true abstinence and having a negative urine pregnancy test at Screening and Day -1, or
- using double barrier contraception protection, out of which one should be a physical barrier method, such as adequate hormonal method (eg, contraceptive implants, injectables, oral contraceptives) and/or non-hormonal methods (eg, intrauterine device, condom, diaphragm or spermicides) from Screening or at least 2 weeks prior to study drug administration (whichever is earlier) until 30 days after intake of study medication and having a negative urine pregnancy test at Screening and Day -1.
Show all 12Show fewer
- Males with partners of childbearing potential may be enrolled if they are:
- documented to be surgically sterile (vasectomy), or
- practicing true abstinence, or
- using adequate double barrier contraception method, out of which one should be a physical barrier for 90 days after the drug intake.
- BMI 18.0 - 35.0 kg/m2, inclusive, where BMI (kg/m2) = body weight (kg) / height2 (m2).
- Patients with diabetes mellitus can be included provided that the disease is controlled (as judged by the PI).
Who cannot join
- Clinically relevant abnormal history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests at the pre-trial screening assessment that the Investigator judges as likely to interfere with the objectives of the trial or the safety of the volunteer except for conditions associated with hepatic impairment in subjects with liver cirrhosis (Groups 1 and 2).
- Surgery (eg stomach bypass) or medical condition that might significantly affect absorption of medicines (as judged by the PI).
- Uncontrolled treated/untreated hypertension (defined as a mean of 3 repeated measurements for systolic blood pressure greater than or equal to 160 mmHg and/or diastolic blood pressure greater than or equal to 105 mmHg); current or documented history of repeated clinically significant hypotension or severe episodes of orthostatic hypotension (systolic blood pressure <90 mmHg and/or diastolic blood pressure less than 50 mmHg).
- History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
- Participation in another investigational drug trial within 30 days prior to dosing (or 5 times the half-life of the drug, whichever is longer) or exposure to more than three new investigational agents within 12 months prior to enrolment.
- Acute illness within 14 days prior to dosing unless mild in severity and approved by the Investigator and Sponsor's medical representative.
Show all 17Show fewer
- Presence of active infection requiring antibiotics.
- History of cancer (judged not to be in full remission) or presence of cancer (except basal cell skin cancer or squamous cell skin cancer) as judged by the Investigator.
- Positive urine drug screen (if not due to concomitant medication) or alcohol breath test at Screening and/or Day -1.
- History of drug abuse within the last 2 years.
- Ingestion of alcohol and caffeine within 24 hours prior to dosing and during confinement. Regular alcohol consumption must not exceed 21 units for males and 14 units for females per week (1 unit equals 340 mL of beer, 115 mL of wine or 43 mL of spirits).
- Smoking of more than 10 cigarettes or equivalent per day.
- Concomitant use of medications known to be strong cytochrome (CYP) P450 inducers or inhibitors within 21 days prior to study drug administration.
- Consumption of grapefruit, grapefruit juice, pomelo, or Seville oranges within 7 days prior to study drug administration and during the study conduct.
- Positive serology for anti-Human immunodeficiency virus subtype 1 or 2.
- Loss of more than 450 mL blood during the 3 months before the trial (eg, as a blood donor).
- Female subjects who are pregnant, nursing, or planning to become pregnant during the study.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: A Multi-Center, Open-Label Phase I Study to Investigate the Effect of Different Degrees of Hepatic Impairment on the Single-Dose Pharmacokinetics of EVP-6124 in Patients With Hepatic Impairment Compared to Subjects With Normal Hepatic Function
The purpose of this study is to assess the pharmacokinetics of EVP-6124 and metabolites after a single oral dose in subjects with mild, moderate and severe hepatic impairment compared with subjects with normal hepatic function.
- Conditions
- Hepatic Impairment
- Being tested
- Experimental: EVP-6124
- Keywords
- Pharmacokinetic, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: EVP-6124Drug
| Study group | Role | What they receive |
|---|---|---|
| EVP-6124, single dose | Experimental | Single dose, Tablet, single administration, Day 1 Receives: Drug: Experimental: EVP-6124 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of EVP-6124 and metabolites after a single oral dose in subjects with mild, moderate and severe hepatic impairment compared with subjects with normal hepatic function.
Measured: Oral clearance of EVP-6124, Maximum plasma concentration, Terminal elimination half life, and Total area under the plasma concentration time curve from time t to time infinity [Time Frame 0-288 hours postdose]
Secondary outcomes (1)
Safety and tolerability of oral EVP-6124 in subjects with mild, moderate and severe hepatic impairment and in subjects with normal hepatic function.
Adverse events, serious adverse events, and concomitant medications will be continuously monitored starting after the time of informed consent through the safety follow-up visit. Assessments will be made via recording of adverse events, concomitant medications, laboratory safety tests, vital signs, 12-lead ECGs and physical examinations.
Measured: Day 1 to Day 13 or Early Termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2014
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- FORUM Pharmaceuticals Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01984736
- Sponsor's protocol ID
- EVP-6124-020
- Other IDs
- 2012-004467-53
- Status last verified
- Jan 2015
- First submitted
- 21 Oct 2013
- Last updated
- 15 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Open-Label Phase I Study to Investigate the Effect of Different Degrees of Hepatic Impairment on the Single-Dose Pharmacokinetics of EVP-6124 in Patients With Hepatic Impairment Compared to Subjects With Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT01984736
- Acronym / sponsor ID
- EVP-6124-020
- Conditions
- Hepatic Impairment
- Keywords
- Pharmacokinetic, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- FORUM Pharmaceuticals IncIndustry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Study start
- Jun 2013
- Primary completion
- Dec 2014 (actual)
- First posted
- 15 Nov 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.
The purpose of this study is to assess the pharmacokinetics of EVP-6124 and metabolites after a single oral dose in subjects with mild, moderate and severe hepatic impairment compared with subjects with normal hepatic function.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EVP-6124, single dose | Experimental | Drug: Experimental: EVP-6124Single dose, Tablet, single administration, Day 1 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Adult male or female subjects age 18 to 65 years (both inclusive).
- Able to understand and willing to sign the Informed Consent Form and able to comply with the study restrictions.
- Females may enroll if they are:
- Males with partners of childbearing potential may be enrolled if they are:
- BMI 18.0 - 35.0 kg/m2, inclusive, where BMI (kg/m2) = body weight (kg) / height2 (m2).
Key exclusion criteria (17 listed)
- Clinically relevant abnormal history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests at the pre-trial screening assessment that the Investigator judges as likely to interfere with the objectives of the trial or the safety of the volunteer except for conditions associated with hepatic impairment in subjects with liver cirrhosis (Groups 1 and 2).
- Surgery (eg stomach bypass) or medical condition that might significantly affect absorption of medicines (as judged by the PI).
- Uncontrolled treated/untreated hypertension (defined as a mean of 3 repeated measurements for systolic blood pressure greater than or equal to 160 mmHg and/or diastolic blood pressure greater than or equal to 105 mmHg); current or documented history of repeated clinically significant hypotension or severe episodes of orthostatic hypotension (systolic blood pressure <90 mmHg and/or diastolic blood pressure less than 50 mmHg).
- History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
- Participation in another investigational drug trial within 30 days prior to dosing (or 5 times the half-life of the drug, whichever is longer) or exposure to more than three new investigational agents within 12 months prior to enrolment.
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 |
|---|---|---|
| Experimental: EVP-6124 | Drug | EVP-6124, single dose |
Primary outcome
Pharmacokinetics of EVP-6124 and metabolites after a single oral dose in subjects with mild, moderate and severe hepatic impairment compared with subjects with normal hepatic function.
Time frame: Oral clearance of EVP-6124, Maximum plasma concentration, Terminal elimination half life, and Total area under the plasma concentration time curve from time t to time infinity [Time Frame 0-288 hours postdose]
1 secondary outcome
Safety and tolerability of oral EVP-6124 in subjects with mild, moderate and severe hepatic impairment and in subjects with normal hepatic function.
Time frame: Day 1 to Day 13 or Early Termination
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 15 Jan 2015.
Related trials for Hepatic Impairment
RecruitingPhase 1
A Study to Evaluate the Pharmacokinetics (PK) and Safety of a Single Dose of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Normal Hepatic Function and Participants With Hepatic Impairment
Hepatic Impairment
RecruitingPhase 1
A Phase I Study to Investigate the Effect of Hepatic Impairment of AZD9550 and AZD6234
Hepatic Impairment
Not yet recruitingPhase 1
Aleniglipron Hepatic Impairment Study
Hepatic Impairment
Not yet recruitingPhase 1
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Sonrotoclax in Participants With Severe Hepatic Impairment
Hepatic Impairment, Healthy Adult Participants
Not yet recruitingPhase 1
A Study to Assess the Safety, Tolerability and Pharmacokinetics of ABI-6250 in Participants With Mild Hepatic Impairment Compared With Participants With Normal Hepatic Function
Mild Hepatic Imparement
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.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Experimental: EVP-6124 in people with Hepatic Impairment, run by FORUM Pharmaceuticals Inc at 3 sites in 3 countries.
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 12 inclusion and 17 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 15 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Czechia, Poland, Slovakia. 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?
Pharmacokinetics of EVP-6124 and metabolites after a single oral dose in subjects with mild, moderate and severe hepatic impairment compared with subjects with normal hepatic function. (time frame: Oral clearance of EVP-6124, Maximum plasma concentration, Terminal elimination half life, and Total area under the plasma concentration time curve from time t to time infinity [Time Frame 0-288 hours postdose]). 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 15 Jan 2015.