Mild Hepatic DysfunctionPhase 1NCT01358565
Pharmacokinetics Of Orally Administered Fx-1006A In Subjects With Hepatic Dysfunction
A Phase 1 study testing Fx-1006A in people with Mild Hepatic Dysfunction and Moderate Hepatic Dysfunction, run by Pfizer at 1 site in South Africa.
Trial summary
This is a Phase I, open-label, single-dose study designed to assess the effects of hepatic dysfunction on the PK of orally administered Fx-1006A 20 mg soft gelatin capsules. An adaptive 2-stage study design will be implemented. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Hepatic Dysfunction, Moderate Hepatic Dysfunction
- What is being tested?
- Fx-1006A
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSouth Africa
- Study dates
- Nov 2010to Apr 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All Subjects
- Subject is male or female (female subjects must be of non-child-bearing potential or willing to use a medically acceptable form of birth control during the study).
- Subject is between 18 to 70 years of age, inclusive.
- Subject is a cigarette smoker, consuming less than 15 cigarettes per day.
- Subject has given written informed consent.
- Hepatic Dysfunction Subjects:
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- Subject has hepatic dysfunction:
- Study Stage 1: Subject has moderate hepatic dysfunction (Child-Pugh score of 7-9, inclusive)
- Study Stage 2 (if commenced): Subject has mild hepatic dysfunction (Child-Pugh score of 5-6, inclusive)
- Subject's hepatic disease is deemed stable by the Investigator.
- Subject's pre-study clinical laboratory findings are within normal range or if outside of the normal range, deemed associated with underlying hepatic dysfunction or not clinically significant in the opinion of the Investigator and the sponsor.
- Normal Hepatic Function Subjects:
- Subject is considered to be in good health in the opinion of the Investigator, as determined by:
- A pre-study physical examination with no clinically significant abnormalities
- Vital signs within normal ranges
- An ECG with no clinically significant abnormalities
- Subject's pre-study clinical laboratory findings are within normal range or if outside of the normal range not deemed clinically significant in the opinion of the Investigator and the Sponsor.
Who cannot join
- Subject has had a clinically significant illness in the four (4) weeks before screening.
- Subject shows evidence of a clinically significant underlying medical condition, including renal, cardiovascular, or metabolic dysfunction that, in the opinion of the Investigator, would represent a risk of study participation.
- Subject has any other clinically significant laboratory abnormality, as determined by the Investigator, within 21 days before dosing on Day 1.
- Subject has a history of clinically important disease that, in the opinion of the investigator, may put the subject at risk because of participation in this study.
- Subject is enrolled or plans to enroll in another clinical trial during this study or has received an investigational drug/device within 60 days before Day 1.
- Subject is known to be hepatitis B surface antigen (HbsAg) positive, anti-hepatitis C antibody (anti-HCV) positive, or human immunodeficiency virus (HIV) positive, or has any positive result during Screening.
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- Subject has a history of alcohol abuse, or illicit drug use, physical dependence to any opioid, or drug abuse or addiction.
- Subject has a history of significant mental illness.
- Subject has positive urine drug screen test results within 21 days before Day 1, excluding alcohol. Alcohol consumption is not permitted within 72 hours before Day 1.
- Subject has a history of complications associated with providing blood samples.
- Subject reports donating greater than 150 mL of blood or donating plasma via plasmapheresis within 28 days prior to enrollment. All subjects will be advised not to donate blood for four weeks after completing the study.
- Hepatic Dysfunction Subjects:
- Subject has an encephalopathy grade > 1.
- Subject has any clinically significant laboratory abnormality not associated with underlying hepatic impairment, as determined by the Investigator, within 21 days before dosing on Day 1.
- Unless being used to treat the subject's underlying hepatic disease, the subject has taken an over the counter (OTC) medication (including non-steroidal anti-inflammatory drugs (NSAIDs) or herbal preparations) within 48 hours before Day 1.
- Normal Hepatic Function Subjects:
- Use of prescription medications in the 14 days prior to Day 1.
- Subject has taken an OTC medication (including NSAIDs or herbal preparations) within 48 hours before Day 1.
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Pfizer Investigational Site
Newton Park, Port Elizabeth, 6045
About this study
This is a Phase I, open-label, single-dose study designed to assess the effects of hepatic dysfunction on the PK of orally administered Fx-1006A 20 mg soft gelatin capsules.
An adaptive 2-stage study design will be implemented. Initially (Stage 1), a group of 9 subjects with moderate hepatic dysfunction (Child-Pugh score of 7-9, inclusive) followed by a group of 9 healthy volunteer subjects with normal hepatic function who are comparable in age, gender, and weight to the hepatically impaired subjects will be enrolled to receive a single oral 20 mg dose of Fx-1006A each.
Read more
Data obtained from the first 2 groups will be analyzed and reviewed by the Sponsor to determine whether Fx-1006A PK is altered by hepatic dysfunction. If it is determined that hepatic dysfunction affects Fx-1006A PK, then Stage 2 will be commenced. During Stage 2, a group of 9 subjects with mild impairment (Child-Pugh score of 5-6, inclusive) will be enrolled to receive a single oral 20 mg dose of Fx-1006A each. Additional subjects with normal hepatic function may be enrolled to ensure appropriate demographic matching to the mild hepatically impaired subjects, with respect to age, gender, and weight.
During Screening, subjects will provide written informed consent to participate in the study and be reviewed against the study entrance criteria (including assessment of hepatic function) to determine eligibility. All subjects will provide blood and urine samples for clinical laboratory testing, drug testing, and pregnancy testing to determine eligibility.
Subjects who meet the entrance criteria during Screening will check in to the clinical site 1 day prior to dosing (Day 0) in the evening, and will be reviewed against the entrance criteria to confirm eligibility. Subjects will remain inpatient overnight for pre-dose assessments. Subjects will be fasted for a minimum of 8 hours prior to dosing the following day (water is allowed).
The single Fx-1006A dose will be administered on Day 1 under supervision of the Investigator or appropriate clinical site staff. Subjects will remain fasted for 4 hours after dosing (water is allowed) and will remain inpatient overnight for safety monitoring and PK sample collection.
Subjects will be discharged on Day 2, after they have completed the study procedures and the Investigator has determined that the subject is clinically stable. Subjects will return to the clinical site for out-patient visits on Days 3, 4, 6, 9, 12, and 16 for safety evaluations and PK sample collection. Day 16 will be the end of study visit.
- Being tested
- Fx-1006A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fx-1006ADrug
A single oral 20 mg dose of Fx-1006A will be administered on Day 1 followed by 16 days of follow-up.
Fx-1006ADrug
A single oral 20 mg dose of Fx-1006A will be administered on Day 1 followed by 16 days of follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Mild and Moderate Hepatic Dysfunction | Active comparator | Patients with mild and moderate hepatic dysfunction Receives: Drug: Fx-1006A |
| Healthy Volunteers | Active comparator | Healthy volunteers Receives: Drug: Fx-1006A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters are AUC0-last and Cmax
Measured: Daily
Secondary outcomes (1)
Parameters are AUC0-inf, Cl, Tmax, t1/2; AUC, Cmax, and Cl will also be expressed in terms of unbound concentrations using the free fraction determined from protein binding assessments
Measured: Daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2011 (estimated)
- Study startNov 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Hepatic DysfunctionStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01358565
- Sponsor's protocol ID
- FX1A-105
- Other IDs
- B3461016
- Status last verified
- Jun 2011
- First submitted
- 20 May 2011
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics Of Orally Administered Fx-1006A In Subjects With Hepatic Dysfunction
- ClinicalTrials.gov ID
- NCT01358565
- Acronym / sponsor ID
- FX1A-105
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 23 May 2011 (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.
This is a Phase I, open-label, single-dose study designed to assess the effects of hepatic dysfunction on the PK of orally administered Fx-1006A 20 mg soft gelatin capsules.
An adaptive 2-stage study design will be implemented. Initially (Stage 1), a group of 9 subjects with moderate hepatic dysfunction (Child-Pugh score of 7-9, inclusive) followed by a group of 9 healthy volunteer subjects with normal hepatic function who are comparable in age, gender, and weight to the hepatically impaired subjects will be enrolled to receive a single oral 20 mg dose of Fx-1006A each.
Data obtained from the first 2 groups will be analyzed and reviewed by the Sponsor to determine whether Fx-1006A PK is altered by hepatic dysfunction. If it is determined that hepatic dysfunction affects Fx-1006A PK, then Stage 2 will be commenced. During Stage 2, a group of 9 subjects with mild impairment (Child-Pugh score of 5-6, inclusive) will be enrolled to receive a single oral 20 mg dose of Fx-1006A each. Additional subjects with normal hepatic function may be enrolled to ensure appropriate demographic matching to the mild hepatically impaired subjects, with respect to age, gender, and weight.
During Screening, subjects will provide written informed consent to participate in the study and be reviewed against the study entrance criteria (including assessment of hepatic function) to determine eligibility. All subjects will provide blood and urine samples for clinical laboratory testing, drug testing, and pregnancy testing to determine eligibility.
Subjects who meet the entrance criteria during Screening will check in to the clinical site 1 day prior to dosing (Day 0) in the evening, and will be reviewed against the entrance criteria to confirm eligibility. Subjects will remain inpatient overnight for pre-dose assessments. Subjects will be fasted for a minimum of 8 hours prior to dosing the following day (water is allowed).
The single Fx-1006A dose will be administered on Day 1 under supervision of the Investigator or appropriate clinical site staff. Subjects will remain fasted for 4 hours after dosing (water is allowed) and will remain inpatient overnight for safety monitoring and PK sample collection.
Subjects will be discharged on Day 2, after they have completed the study procedures and the Investigator has determined that the subject is clinically stable. Subjects will return to the clinical site for out-patient visits on Days 3, 4, 6, 9, 12, and 16 for safety evaluations and PK sample collection. Day 16 will be the end of study visit.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mild and Moderate Hepatic Dysfunction | Active comparator | Drug: Fx-1006APatients with mild and moderate hepatic dysfunction |
| Healthy Volunteers | Active comparator | Drug: Fx-1006AHealthy volunteers |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- All Subjects
- Subject is male or female (female subjects must be of non-child-bearing potential or willing to use a medically acceptable form of birth control during the study).
- Subject is between 18 to 70 years of age, inclusive.
- Subject is a cigarette smoker, consuming less than 15 cigarettes per day.
- Subject has given written informed consent.
Key exclusion criteria (18 listed)
- Subject has had a clinically significant illness in the four (4) weeks before screening.
- Subject shows evidence of a clinically significant underlying medical condition, including renal, cardiovascular, or metabolic dysfunction that, in the opinion of the Investigator, would represent a risk of study participation.
- Subject has any other clinically significant laboratory abnormality, as determined by the Investigator, within 21 days before dosing on Day 1.
- Subject has a history of clinically important disease that, in the opinion of the investigator, may put the subject at risk because of participation in this study.
- Subject is enrolled or plans to enroll in another clinical trial during this study or has received an investigational drug/device within 60 days before Day 1.
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 |
|---|---|---|
| Fx-1006AA single oral 20 mg dose of Fx-1006A will be administered on Day 1 followed by 16 days of follow-up. | Drug | Mild and Moderate Hepatic Dysfunction |
| Fx-1006AA single oral 20 mg dose of Fx-1006A will be administered on Day 1 followed by 16 days of follow-up. | Drug | Healthy Volunteers |
Primary outcome
Pharmacokinetic parameters are AUC0-last and Cmax
Time frame: Daily
1 secondary outcome
Parameters are AUC0-inf, Cl, Tmax, t1/2; AUC, Cmax, and Cl will also be expressed in terms of unbound concentrations using the free fraction determined from protein binding assessments
Time frame: Daily
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 23 Jun 2011.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
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 Fx-1006A in people with Mild Hepatic Dysfunction and Moderate Hepatic Dysfunction, run by Pfizer at 1 site in South Africa.
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 17 inclusion and 18 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 23 Jun 2011. 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 South Africa. 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?
Pharmacokinetic parameters are AUC0-last and Cmax (time frame: Daily). 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 23 Jun 2011.