Hepatic ImpairmentPhase 1NCT03376841
Impact of Severe Hepatic Impairment on Pharmacokinetics of Cenicriviroc and Its Metabolites
A Phase 1 study testing Cenicriviroc in people with Hepatic Impairment, run by Allergan at 2 sites in United States.
Trial summary
The objective of this study is to assess the pharmacokinetics (PK), safety, and tolerability profiles of cenicriviroc (CVC) and its metabolites (M-I and M-II) in participants with severely impaired hepatic function compared with matched healthy participants following single-dose administration 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?
- Cenicriviroc
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Jun 2017to 17 Dec 2017
- 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
- Sign the ICF and have the mental capability to understand it
- If female, have a negative result from a serum pregnancy test at screening and a negative result from a serum or urine pregnancy test on Day -1
- If male, agree to use an effective method of contraception (ie, condom plus diaphragm with spermicide or condom plus spermicide) and not have their partners become pregnant for at least 30 days after dosing study treatment, or have been sterilized for at least 1 year
- If female of childbearing potential, agree to use an effective method of contraception (ie, condom plus diaphragm with spermicide, condom plus spermicide, or nonhormonal intrauterine device) and not become pregnant for at least 30 days after dosing study treatment. Females who are at least 2 years postmenopausal (with supporting documentation from an obstetrician/gynecologist) or who have had tubal ligation or hysterectomy (with supporting documentation from the physician who performed the surgery) will not be considered to be of childbearing potential
- Be nonsmoking (never smoked or have not smoked in the previous 2 years) or a light smoker (fewer than 10 cigarettes per day within 1 week prior to study treatment administration)
- Have a body mass index (BMI) ≥ 18 kg/m2 and ≤ 42 kg/m2
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- Inclusion Criteria for Participants with Severely Impaired Hepatic Function:
- Have chronic liver disease and/or cirrhosis documented by the presence of at least 1 of the following:
- Liver biopsy with histologic findings consistent with cirrhosis
- Computerized tomographic or ultrasonographic evidence of liver disease with or without portal hypertension
- Physical examination and clinical and laboratory evidence of chronic liver disease
- Colloid shift on a liver-spleen scan
Who cannot join
- Known hypersensitivity to cenicriviroc and other chemokine receptor 2 and/or 5 (CCR2 and/or CCR5) antagonists such as maraviroc (CCR5 antagonist)
- History of substance abuse within the previous 2 years
- Dosing in any other clinical investigation using an experimental drug requiring repeated blood or plasma draws within 30 days of study treatment administration
- Participation in a blood or plasma donation program within 60 or 30 days, respectively, of study treatment administration
- Consumption of caffeine within 48 hours prior to dosing; consumption of grapefruit containing products, vegetables from the mustard green family (eg, kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, mustard), foods containing poppy seeds, and charbroiled meats within 14 days prior to dosing; or consumption of alcohol within 72 hours prior to dosing before study treatment administration
- Employee, or immediate relative of an employee, of the sponsor, any of its affiliates or partners, or the study center
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- Previously taken cenicriviroc or previously participated in an investigational study of cenicriviroc
- Pregnant or breastfeeding (female participants)
- Exclusion Criteria for Participants with Severely Impaired Hepatic Function:
- Have an acute exacerbation of liver disease as indicated by worsening clinical signs and/or laboratory tests within the 4 weeks before study treatment administration
- Have ascites that will require paracentesis within 1 week of dosing or during the study period
- Have gastrointestinal hemorrhage due to esophageal varices, peptic ulcers or Mallory Weiss Syndrome within 6 months before Day 1, unless banded and stable
- Have a Child-Pugh score of < 10
- Any clinical condition other than hepatic impairment or previous surgery that might affect the absorption, distribution, biotransformation, or excretion of cenicriviroc and its metabolites
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Clinical Pharmacology of Miami
Miami, Florida, 33014
Orlando Clinical Research Center
Orlando, Florida, 32809
About this study
Official title: An Open-Label Study to Evaluate the Effect of Severe Hepatic Impairment on the Pharmacokinetics of Cenicriviroc and Its Metabolites Following Single Dose Administration
The objective of this study is to assess the pharmacokinetics (PK), safety, and tolerability profiles of cenicriviroc (CVC) and its metabolites (M-I and M-II) in participants with severely impaired hepatic function compared with matched healthy participants following single-dose administration
- Conditions
- Hepatic Impairment
- Being tested
- Cenicriviroc
- Keywords
- Liver insufficiency, Hepatic Impairment, Cenicriviroc, Pharmacokinetics
- Medical subject headings
- Hepatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CenicrivirocDrug
Also called CVC
1 tablet; single-dose oral administration
| Study group | Role | What they receive |
|---|---|---|
| Severe hepatic impairment | Experimental | Cenicriviroc tablet; single-dose oral administration Receives: Drug: Cenicriviroc |
| Normal Hepatic function | Experimental | Cenicriviroc tablet; single-dose oral administration Receives: Drug: Cenicriviroc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC) from time 0 to time t (AUC0-t)
Measured: 6 days (144 hours)
AUC from time 0 to infinity (AUC0-∞)
Measured: 6 days (144 hours)
Maximum plasma drug concentration (Cmax)
Measured: 6 days (144 hours)
Secondary outcomes (5)
Time of maximum plasma drug concentration (Tmax)
Measured: 6 days (144 hours)
Terminal elimination rate constant
Measured: 6 days (144 hours)
Terminal elimination half-life (T½)
Measured: 6 days (144 hours)
Total body clearance of drug from plasma (CL/F for CVC only)
Measured: 6 days (144 hours)
Volume of distribution during the terminal phase (Vz/F for CVC only)
Measured: 6 days (144 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start6 Jun 2017
- Primary completion24 Nov 2017
- Study completion17 Dec 2017
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Surya Ayalasomayajula, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03376841
- Sponsor's protocol ID
- 3152-102-002
- Status last verified
- Jan 2018
- First submitted
- 2 Aug 2017
- Last updated
- 11 Jan 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Evaluate the Effect of Severe Hepatic Impairment on the Pharmacokinetics of Cenicriviroc and Its Metabolites Following Single Dose Administration
- ClinicalTrials.gov ID
- NCT03376841
- Acronym / sponsor ID
- 3152-102-002
- Conditions
- Hepatic Impairment
- Keywords
- Liver insufficiency, Hepatic Impairment, Cenicriviroc, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 24 Nov 2017 (actual)
- Study completion
- 17 Dec 2017 (actual)
- First posted
- 19 Dec 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 objective of this study is to assess the pharmacokinetics (PK), safety, and tolerability profiles of cenicriviroc (CVC) and its metabolites (M-I and M-II) in participants with severely impaired hepatic function compared with matched healthy participants following single-dose administration
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Severe hepatic impairment | Experimental | Drug: CenicrivirocCenicriviroc tablet; single-dose oral administration |
| Normal Hepatic function | Experimental | Drug: CenicrivirocCenicriviroc tablet; single-dose oral administration |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Sign the ICF and have the mental capability to understand it
- If female, have a negative result from a serum pregnancy test at screening and a negative result from a serum or urine pregnancy test on Day -1
- If male, agree to use an effective method of contraception (ie, condom plus diaphragm with spermicide or condom plus spermicide) and not have their partners become pregnant for at least 30 days after dosing study treatment, or have been sterilized for at least 1 year
- If female of childbearing potential, agree to use an effective method of contraception (ie, condom plus diaphragm with spermicide, condom plus spermicide, or nonhormonal intrauterine device) and not become pregnant for at least 30 days after dosing study treatment. Females who are at least 2 years postmenopausal (with supporting documentation from an obstetrician/gynecologist) or who have had tubal ligation or hysterectomy (with supporting documentation from the physician who performed the surgery) will not be considered to be of childbearing potential
- Be nonsmoking (never smoked or have not smoked in the previous 2 years) or a light smoker (fewer than 10 cigarettes per day within 1 week prior to study treatment administration)
Key exclusion criteria (14 listed)
- Known hypersensitivity to cenicriviroc and other chemokine receptor 2 and/or 5 (CCR2 and/or CCR5) antagonists such as maraviroc (CCR5 antagonist)
- History of substance abuse within the previous 2 years
- Dosing in any other clinical investigation using an experimental drug requiring repeated blood or plasma draws within 30 days of study treatment administration
- Participation in a blood or plasma donation program within 60 or 30 days, respectively, of study treatment administration
- Consumption of caffeine within 48 hours prior to dosing; consumption of grapefruit containing products, vegetables from the mustard green family (eg, kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, mustard), foods containing poppy seeds, and charbroiled meats within 14 days prior to dosing; or consumption of alcohol within 72 hours prior to dosing before study treatment administration
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 |
|---|---|---|
| CenicrivirocAlso: CVC1 tablet; single-dose oral administration | Drug | Normal Hepatic function, Severe hepatic impairment |
Primary outcome
Area under the plasma concentration versus time curve (AUC) from time 0 to time t (AUC0-t)
Time frame: 6 days (144 hours)
AUC from time 0 to infinity (AUC0-∞)
Time frame: 6 days (144 hours)
Maximum plasma drug concentration (Cmax)
Time frame: 6 days (144 hours)
5 secondary outcomes
Time of maximum plasma drug concentration (Tmax)
Time frame: 6 days (144 hours)
Terminal elimination rate constant
Time frame: 6 days (144 hours)
Terminal elimination half-life (T½)
Time frame: 6 days (144 hours)
Total body clearance of drug from plasma (CL/F for CVC only)
Time frame: 6 days (144 hours)
Volume of distribution during the terminal phase (Vz/F for CVC only)
Time frame: 6 days (144 hours)
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 11 Jan 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.
Surya Ayalasomayajula study director
Allergan
2 sites 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 people with Hepatic Impairment, run by Allergan at 2 sites 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 12 inclusion and 14 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 11 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Area under the plasma concentration versus time curve (AUC) from time 0 to time t (AUC0-t) (time frame: 6 days (144 hours)). The study lists 3 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 11 Jan 2018.