Liver InsufficiencyPhase 1NCT02120547
Phase 1 Study of Multiple-Dose Pharmacokinetics of Cenicriviroc in Subjects With Mild and Moderate Hepatic Impairment
A Phase 1 study testing Cenicriviroc in mild liver impaired and Cenicriviroc in moderate liver impaired in people with Liver Insufficiency, run by Tobira Therapeutics, Inc. at 1 site in United States.
Trial summary
To determine whether CVC exposures are altered in subjects with impaired hepatic function, compared to subjects with normal hepatic function. The results will help guide the clinical use of CVC in patients with hepatic impairment, determine the extent of PK changes, if any, and identify the potential need for dose… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Insufficiency
- What is being tested?
- Cenicriviroc in mild liver impaired and Cenicriviroc in moderate liver impaired
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and non-pregnant, non-lactating females aged 18-65
- Weight ≥ 50.0 kg
- BMI 18.0 - 40.0 kg/m2
- Able to participate, and willing to give written informed consent and to comply with the study restrictions
- Subjects with hepatic impairment will have stable liver disease (Child Pugh A or Child Pugh B)
Who cannot join
- Pregnant or lactating women and male partners of women who are pregnant or lactating
- Uncontrolled treated or untreated hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 105 mmHg)
- QTcF > 450 msec for males and > 470 msec for females at Screening or Day -1
- Donation or loss of blood over 350 mL within 60 days prior to screening
- Any evidence of progressive liver disease within the last 4 weeks for subjects with hepatic impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Pharmacology of Miami, Inc.
Fort Lauderdale, Florida, 33014
About this study
Official title: An Open Label, Phase 1 Study to Evaluate the Effect of Mile and Moderate Hepatic Impairment on the Multiple-Dose Pharmacokinetics of Cenicriviroc (CVC)
To determine whether CVC exposures are altered in subjects with impaired hepatic function, compared to subjects with normal hepatic function. The results will help guide the clinical use of CVC in patients with hepatic impairment, determine the extent of PK changes, if any, and identify the potential need for dose adjustments of CVC in this population.
- Conditions
- Liver Insufficiency
- Being tested
- Cenicriviroc in mild liver impaired, Cenicriviroc in moderate liver impaired
- Keywords
- Liver Insufficiency, Hepatic impairment
- Medical subject headings
- Hepatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cenicriviroc in mild liver impairedDrug
Also called CVC
Subjects with mild hepatic impairment will receive CVC, 1 tablet once daily, for 14 days. Matching healthy subjects will receive CVC, 1 tablet once daily, for 14 days.
Cenicriviroc in moderate liver impairedDrug
Also called CVC
Subjects with moderate hepatic impairment will receive CVC, 1 tablet once daily, for 14 days. Matching healthy subjects will receive CVC, 1 tablet once daily, for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Cenicriviroc in mild liver impaired | Experimental | Subjects with mild liver impaired will receive cenicriviroc, 1 tablet once daily, for 14 days. Matching healthy subjects will receive Cenicriviroc, 1 tablet once daily, for 14 days. Receives: Drug: Cenicriviroc in mild liver impaired |
| Cenicriviroc in moderate liver impaired | Experimental | Subjects with moderate liver impaired will receive cenicriviroc, 1 tablet once daily, for 14 days. Matching healthy subjects will receive Cenicriviroc, 1 tablet once daily, for 14 days. Receives: Drug: Cenicriviroc in moderate liver impaired |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiple-dose pharmacokinetics of CVC
Intensive PK on Days 1 and 14. Trough PK on Days 3-13. Additional free (unbound) CVC will be assessed 2 hours and 24 hours postdose on Day 14.
Measured: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours postdose on Days 1 and 14
Secondary outcomes (1)
Safety and tolerability
Adverse events, concomitant medications, vital signs, 12-lead triplicate ECGs, clinical laboratory tests (chemistry, hematology, urinalysis) and physical examinations will be assessed.
Measured: Days 1 through 35 for hepatic impaired subjects and Days 1-28 for healthy matching subjects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionJul 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver InsufficiencyStudies 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tobira Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenneth C Lasseter, MD, Principal investigator, Clinical Pharmacology of Miami, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02120547
- Sponsor's protocol ID
- TBR 652-1-121
- Status last verified
- Aug 2014
- First submitted
- 18 Apr 2014
- Last updated
- 21 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Phase 1 Study to Evaluate the Effect of Mile and Moderate Hepatic Impairment on the Multiple-Dose Pharmacokinetics of Cenicriviroc (CVC)
- ClinicalTrials.gov ID
- NCT02120547
- Acronym / sponsor ID
- TBR 652-1-121
- Conditions
- Liver Insufficiency
- Keywords
- Liver Insufficiency, Hepatic impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Tobira Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 22 Apr 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.
To determine whether CVC exposures are altered in subjects with impaired hepatic function, compared to subjects with normal hepatic function. The results will help guide the clinical use of CVC in patients with hepatic impairment, determine the extent of PK changes, if any, and identify the potential need for dose adjustments of CVC in this population.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cenicriviroc in mild liver impaired | Experimental | Drug: Cenicriviroc in mild liver impairedSubjects with mild liver impaired will receive cenicriviroc, 1 tablet once daily, for 14 days. Matching healthy subjects will receive Cenicriviroc, 1 tablet once daily, for 14 days. |
| Cenicriviroc in moderate liver impaired | Experimental | Drug: Cenicriviroc in moderate liver impairedSubjects with moderate liver impaired will receive cenicriviroc, 1 tablet once daily, for 14 days. Matching healthy subjects will receive Cenicriviroc, 1 tablet once daily, for 14 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and non-pregnant, non-lactating females aged 18-65
- Weight ≥ 50.0 kg
- BMI 18.0 - 40.0 kg/m2
- Able to participate, and willing to give written informed consent and to comply with the study restrictions
- Subjects with hepatic impairment will have stable liver disease (Child Pugh A or Child Pugh B)
Key exclusion criteria (5 listed)
- Pregnant or lactating women and male partners of women who are pregnant or lactating
- Uncontrolled treated or untreated hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 105 mmHg)
- QTcF > 450 msec for males and > 470 msec for females at Screening or Day -1
- Donation or loss of blood over 350 mL within 60 days prior to screening
- Any evidence of progressive liver disease within the last 4 weeks for subjects with hepatic impairment
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 |
|---|---|---|
| Cenicriviroc in mild liver impairedAlso: CVCSubjects with mild hepatic impairment will receive CVC, 1 tablet once daily, for 14 days. Matching healthy subjects will receive CVC, 1 tablet once daily, for 14 days. | Drug | Cenicriviroc in mild liver impaired |
| Cenicriviroc in moderate liver impairedAlso: CVCSubjects with moderate hepatic impairment will receive CVC, 1 tablet once daily, for 14 days. Matching healthy subjects will receive CVC, 1 tablet once daily, for 14 days. | Drug | Cenicriviroc in moderate liver impaired |
Primary outcome
Multiple-dose pharmacokinetics of CVC
Time frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours postdose on Days 1 and 14
Intensive PK on Days 1 and 14. Trough PK on Days 3-13. Additional free (unbound) CVC will be assessed 2 hours and 24 hours postdose on Day 14.
1 secondary outcome
Safety and tolerability
Time frame: Days 1 through 35 for hepatic impaired subjects and Days 1-28 for healthy matching subjects
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 21 Aug 2014.
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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.
Kenneth C Lasseter, MD principal investigator
Clinical Pharmacology of Miami, Inc.
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 Cenicriviroc in mild liver impaired and Cenicriviroc in moderate liver impaired in people with Liver Insufficiency, run by Tobira Therapeutics, Inc. at 1 site in United States.
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 5 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 21 Aug 2014. 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 United States. 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?
Multiple-dose pharmacokinetics of CVC (time frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours postdose on Days 1 and 14). 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 21 Aug 2014.