Hepatic ImpairmentPhase 1NCT05391724
Safety and Pharmacokinetics of CMX001 in Impaired Hepatic Function and Healthy Subjects
A Phase 1 study testing CMX001 in people with Hepatic Impairment, run by Jazz Pharmaceuticals at 3 sites in United States.
Trial summary
This is an open-label, non-randomized, multi-center, sequential group, safety, tolerance, and Pharmacokinetic study of a single dose of CMX001 administered at 2 mg/kg of ideal body weight rounded to the closest 20 mg in fasted healthy control subjects compared with that in fasted subjects with moderate and severe… 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?
- CMX001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2011to Sep 2011
- 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
- Able to comprehend and willing to sign an informed consent form (ICF);
- Male or female subjects, between 18 and 65 years of age, inclusive;
- Within body mass index (BMI) range 18 to 40 kg/m2, inclusive;
- Negative test for selected drugs of abuse at Screening (does not include alcohol) and at Check-in (does include alcohol); positive drug screens in the hepatically-impaired subjects may be allowed with the confirmation of use of the medication under supervision of a physician)
- Negative HIV antibody and hepatitis B surface antigen (HBsAg) screens;
- Female subjects will be non-pregnant, non-lactating, and either postmenopausal for at least 1 year (with follicle-stimulating hormone (FSH) levels ≥40 mIU/mL), surgically sterile (e.g., tubal ligation, hysterectomy) for at least 90 days, or agree to use from the time of signing the ICF until 30 days after Study Discharge one of the following forms of contraception: a non-hormonal intrauterine device (IUD) with spermicide; female condom with spermicide; contraceptive sponge with spermicide; a non-hormonal intravaginal system; diaphragm with spermicide; cervical cap with spermicide; a male sexual partner who agrees to use a male condom with spermicide; or a sterile sexual partner; for all female subjects, the pregnancy test result must be negative at Screening and Check-in;
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- Male subjects will either be sterile or agree to use from Check-in until 45 days following Study Discharge one of the following approved methods of contraception: a male condom with spermicide; a sterile sexual partner; or use by female sexual partner of an IUD with spermicide; a female condom with spermicide; contraceptive sponge with spermicide; an intravaginal system (e.g., NuvaRing®); a diaphragm with spermicide; a cervical cap with spermicide; or oral, implantable, transdermal, or injectable contraceptives.
- For healthy subjects with normal hepatic function:
- Normal hepatic function defined as alanine aminotransferase, aspartate aminotransferase, bilirubin, serum albumin, and gamma glutamyl transferase all within normal limits;
- The absence of clinically-relevant abnormalities identified by a detailed medical history, full physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests;
- Negative hepatitis panel (including HBsAg and hepatitis C virus antibody);
- No medical or surgical conditions that might significantly interfere with gastrointestinal absorption of CMX001.
- For subjects with impaired hepatic function:
- Otherwise healthy subjects as determined by a detailed medical history, complete physical examination, vital signs, 12-lead ECG, and clinical laboratory tests (abnormal findings that are related to the subject's underlying condition are acceptable);
- Satisfy the criteria for Class B or Class C of the modified Child-Turcotte-Pugh (CPT) classification (mild [CPT score of 5 to 6 points], moderate [CPT score of 7 to 9 points], and severe [CPT score of >9 to <12 points]);
- A diagnosis of chronic hepatic impairment due to cirrhosis or fibrosis, not secondary to other diseases, which is confirmed and documented by medical history, physical examination, and/or liver biopsy, hepatic ultrasound, computed tomography scan, or magnetic resonance imaging.
Who cannot join
- Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic (healthy control subjects only), renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the Investigator, Sponsor, and/or Sponsor's representative);
- Any non-hepatic disease or condition that could affect safety or data interpretation (as determined by the Investigator, Sponsor, and/or Sponsor's representative);
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, including cidofovir (CDV), food, or other substance, unless approved by the Investigator, Sponsor, and/or Sponsor's representative;
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs except that appendectomy and/or hernia repair will be allowed;
- History of any condition possibly affecting drug absorption (e.g., gastrectomy, active peptic ulcer) within the last 3 months;
- serum albumin <3 g/dL;
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- History or presence of an abnormal ECG, which, in the opinion of the Investigator, Sponsor, and/or Sponsor's representative, is clinically significant;
- History of alcoholism or drug addiction within 1 year prior to Check-in (healthy control subjects only);
- Use of any tobacco- or nicotine-containing products within 6 months prior to Check-in (healthy control subjects only);
- Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 30 days (or 5 half-lives, whichever is longer) prior to Check-in;
- Use of oral, implantable, injectable, or transdermal contraceptives within 14 days prior to Check-in (female subjects only);
- For healthy control subjects, use of any prescription medications/products within 14 days prior to Check-in, unless deemed acceptable by the Investigator and Sponsor;
- For healthy control subjects, use of any over-the-counter (OTC), non-prescription preparations (including vitamins, minerals, and phytotherapeutic/ herbal/plant-derived preparations) within 7 days prior to Check-in, unless deemed acceptable by the Investigator, Sponsor, and/or Sponsor's representative;
- Use of alcohol-, grapefruit-, or caffeine-containing foods or beverages within 72 hours prior to Check-in, unless deemed acceptable by the Investigator, Sponsor, and/or Sponsor's representative;
- Poor peripheral venous access;
- Donation of blood during the period of 30 days prior to Screening or donation of plasma during the period of 2 weeks prior to Screening;
- Receipt of blood products within 2 months prior to Check-in;
- Any acute or chronic non-hepatic condition that, in the opinion of the Investigator, Sponsor, and/or Sponsor's representative, would limit the subject's ability to complete and/or participate in this clinical study;
- History of liver transplant;
- History of febrile illness within 5 days prior to dosing.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Elite Research
Miami, Florida, 33169
DaVita Clinical Research
Minneapolis, Minnesota, 55404
Orlando Clinical Research Center
Orlando, Florida, 32809
About this study
Official title: An Open-Label Study to Determine the Safety and Pharmacokinetics of CMX001 in Subjects With Impaired Hepatic Function and Healthy Subjects With Normal Hepatic Function
This is an open-label, non-randomized, multi-center, sequential group, safety, tolerance, and Pharmacokinetic study of a single dose of CMX001 administered at 2 mg/kg of ideal body weight rounded to the closest 20 mg in fasted healthy control subjects compared with that in fasted subjects with moderate and severe hepatic impairment.
Read the detailed description
A maximum of 24 subjects will be studied at multiple sites in the Unites States. Eight subjects with normal hepatic function and 8 subjects with moderate hepatic impairment will be enrolled on Cohort 1 and an additional 8 subjects with severe hepatic impairment may be enrolled in Cohort 2. The severity of hepatic impairment will be assessed according to the Child-Pugh-Turcotte (CPT) score1 (see Table 4-2). Because CMX001 is highly protein-bound, to avoid confounding the PK assessment of hepatic impairment versus hypoalbuminemia, only patients with serum albumin levels >3 g/dL will be enrolled in this study.
Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to Check-in.
Subjects who have met inclusion and exclusion criteria will check in to the clinic on Day -1 and receive a single oral dose of CMX001 (2 mg/kg of ideal body weight rounded to the closest 20 mg) on Day 1. The study design schematic is presented in Table 4-3. Subjects will be discharged from the clinic on Day 2 (if stable in the opinion of the Investigator), return for outpatient visits on Days 3 through 6 for safety assessments and PK sampling, and return for an End of Study Visit on Day 14 ± 2 for safety assessments. Subjects may be confined to the clinic during the period of Day -1 to Day 6 at the discretion of the Investigator, after discussion with the Medical Monitor.
- Conditions
- Hepatic Impairment
- Being tested
- CMX001
- Keywords
- hepatic impairment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMX001Drug
Also called Brincidofovir, BCV
single dose of CMX001 administered at 2 mg/kg of ideal body weight rounded to the closest 20 mg
| Study group | Role | What they receive |
|---|---|---|
| CMX001 | Experimental | single dose of CMX001 administered at 2 mg/kg of ideal body weight rounded to the closest 20 mg Receives: Drug: CMX001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
An objective of this study was to determine the safety following administration of a single dose of CMX001 in subjects with moderate and severe hepatic impairment compared to match subjects with normal hepatic function.
Measured: 6 months
Secondary outcomes (3)
Maximum concentration (Cmax) of moderate and severe hepatic impairment after a single dose of CMX001
An objective of this study was to evaluate the effects of moderate and severe hepatic impairment on the pharmacokinetic (PK) parameters for CMX001 after a single dose, including Cmax.
Measured: 6 months
Time to maximum concentration (Tmax) of moderate and severe hepatic impairment after a single dose of CMX001
An objective of this study was to evaluate the effects of moderate and severe hepatic impairment on the pharmacokinetic (PK) parameters for CMX001 after a single dose, including Tmax.
Measured: 6 months
Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf) of moderate and severe hepatic impairment after a single dose of CMX001
An objective of this study was to evaluate the effects of moderate and severe hepatic impairment on the pharmacokinetic (PK) parameters for CMX001 after a single dose, including AUCinf.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study startFeb 2011
- Primary completionSep 2011
- Study completionSep 2011
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 Jazz PharmaceuticalsThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391724
- Sponsor's protocol ID
- CMX001-106
- Status last verified
- May 2022
- First submitted
- 30 Jun 2011
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Determine the Safety and Pharmacokinetics of CMX001 in Subjects With Impaired Hepatic Function and Healthy Subjects With Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT05391724
- Acronym / sponsor ID
- CMX001-106
- Conditions
- Hepatic Impairment
- Keywords
- hepatic impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 26 May 2022 (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.
This is an open-label, non-randomized, multi-center, sequential group, safety, tolerance, and Pharmacokinetic study of a single dose of CMX001 administered at 2 mg/kg of ideal body weight rounded to the closest 20 mg in fasted healthy control subjects compared with that in fasted subjects with moderate and severe hepatic impairment.
Detailed description
A maximum of 24 subjects will be studied at multiple sites in the Unites States. Eight subjects with normal hepatic function and 8 subjects with moderate hepatic impairment will be enrolled on Cohort 1 and an additional 8 subjects with severe hepatic impairment may be enrolled in Cohort 2. The severity of hepatic impairment will be assessed according to the Child-Pugh-Turcotte (CPT) score1 (see Table 4-2). Because CMX001 is highly protein-bound, to avoid confounding the PK assessment of hepatic impairment versus hypoalbuminemia, only patients with serum albumin levels >3 g/dL will be enrolled in this study.
Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to Check-in.
Subjects who have met inclusion and exclusion criteria will check in to the clinic on Day -1 and receive a single oral dose of CMX001 (2 mg/kg of ideal body weight rounded to the closest 20 mg) on Day 1. The study design schematic is presented in Table 4-3. Subjects will be discharged from the clinic on Day 2 (if stable in the opinion of the Investigator), return for outpatient visits on Days 3 through 6 for safety assessments and PK sampling, and return for an End of Study Visit on Day 14 ± 2 for safety assessments. Subjects may be confined to the clinic during the period of Day -1 to Day 6 at the discretion of the Investigator, after discussion with the Medical Monitor.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CMX001 | Experimental | Drug: CMX001single dose of CMX001 administered at 2 mg/kg of ideal body weight rounded to the closest 20 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Able to comprehend and willing to sign an informed consent form (ICF);
- Male or female subjects, between 18 and 65 years of age, inclusive;
- Within body mass index (BMI) range 18 to 40 kg/m2, inclusive;
- Negative test for selected drugs of abuse at Screening (does not include alcohol) and at Check-in (does include alcohol); positive drug screens in the hepatically-impaired subjects may be allowed with the confirmation of use of the medication under supervision of a physician)
- Negative HIV antibody and hepatitis B surface antigen (HBsAg) screens;
Key exclusion criteria (20 listed)
- Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic (healthy control subjects only), renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the Investigator, Sponsor, and/or Sponsor's representative);
- Any non-hepatic disease or condition that could affect safety or data interpretation (as determined by the Investigator, Sponsor, and/or Sponsor's representative);
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, including cidofovir (CDV), food, or other substance, unless approved by the Investigator, Sponsor, and/or Sponsor's representative;
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs except that appendectomy and/or hernia repair will be allowed;
- History of any condition possibly affecting drug absorption (e.g., gastrectomy, active peptic ulcer) within the last 3 months;
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 |
|---|---|---|
| CMX001Also: Brincidofovir, BCVsingle dose of CMX001 administered at 2 mg/kg of ideal body weight rounded to the closest 20 mg | Drug | CMX001 |
Primary outcome
Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Time frame: 6 months
An objective of this study was to determine the safety following administration of a single dose of CMX001 in subjects with moderate and severe hepatic impairment compared to match subjects with normal hepatic function.
3 secondary outcomes
Maximum concentration (Cmax) of moderate and severe hepatic impairment after a single dose of CMX001
Time frame: 6 months
Time to maximum concentration (Tmax) of moderate and severe hepatic impairment after a single dose of CMX001
Time frame: 6 months
Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf) of moderate and severe hepatic impairment after a single dose of CMX001
Time frame: 6 months
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 26 May 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 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 CMX001 in people with Hepatic Impairment, run by Jazz Pharmaceuticals at 3 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 16 inclusion and 20 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 26 May 2022. 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 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?
Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 (time frame: 6 months). 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 26 May 2022.