Hepatic InsufficiencyPhase 1NCT00969813
A Safety and Tolerability Study of CP-690,550 in Subjects With Hepatic Impairment and Normal Hepatic Function
A Phase 1 study testing CP-690,550 in people with Hepatic Insufficiency, run by Pfizer at 1 site in United States.
Trial summary
This study is designed to evaluate how CP-690,550 is handled by the body in healthy volunteers who have mild and moderate hepatic impairment compared to healthy volunteers with normal hepatic function. This study will also evaluate the safety and tolerability of CP-690,550. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Insufficiency
- What is being tested?
- CP-690,550
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Jan 2010
- 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
- Healthy volunteers who have normal liver function, and subjects who have either mild or moderate liver impairment.
Who cannot join
- Subjects with severe liver impairment
- Subjects who have weakened immune systems
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
South Miami, Florida, 33143
About this study
Official title: A Phase 1, Non-Randomized, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CP-690,550 in Subjects With Hepatic Impairment and Normal Hepatic Function
This study is designed to evaluate how CP-690,550 is handled by the body in healthy volunteers who have mild and moderate hepatic impairment compared to healthy volunteers with normal hepatic function. This study will also evaluate the safety and tolerability of CP-690,550.
- Conditions
- Hepatic Insufficiency
- Being tested
- CP-690,550
- Keywords
- 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.
CP-690,550Drug
Single 10 mg dose of CP-690,550
CP-690,550Drug
Single 10 mg dose of CP-690,550
CP-690,550Drug
Single 10 mg dose of CP-690,550
| Study group | Role | What they receive |
|---|---|---|
| Normal hepatic function | Experimental | Not described Receives: Drug: CP-690,550 |
| Mild hepatic impairment | Experimental | Not described Receives: Drug: CP-690,550 |
| Moderate hepatic impairment | Experimental | Not described Receives: Drug: CP-690,550 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of CP-690,550 in subjects with hepatic impairment compared to subjects with normal hepatic function
Measured: 3 days
Secondary outcomes (1)
Safety and tolerability of CP-690,550 in subjects with hepatic impairment compared to subjects with normal hepatic function
Measured: 10-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2009 (estimated)
- Study startNov 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatic InsufficiencyStudies 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 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
- NCT00969813
- Sponsor's protocol ID
- A3921015
- Status last verified
- Feb 2010
- First submitted
- 31 Aug 2009
- Last updated
- 11 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Lawendy N, Lamba M, Chan G, Wang R, Alvey CW, Krishnaswami S. The effect of mild and moderate hepatic impairment on the pharmacokinetics of tofacitinib, an orally active Janus kinase inhibitor. Clin Pharmacol Drug Dev. 2014 Nov;3(6):421-7. doi: 10.1002/cpdd.143. Epub 2014 Oct 1.
PubMed 27129117
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Non-Randomized, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CP-690,550 in Subjects With Hepatic Impairment and Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT00969813
- Acronym / sponsor ID
- A3921015
- Conditions
- Hepatic Insufficiency
- Keywords
- Hepatic impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 1 Sep 2009 (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 study is designed to evaluate how CP-690,550 is handled by the body in healthy volunteers who have mild and moderate hepatic impairment compared to healthy volunteers with normal hepatic function. This study will also evaluate the safety and tolerability of CP-690,550.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal hepatic function | Experimental | Drug: CP-690,550 |
| Mild hepatic impairment | Experimental | Drug: CP-690,550 |
| Moderate hepatic impairment | Experimental | Drug: CP-690,550 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteers who have normal liver function, and subjects who have either mild or moderate liver impairment.
Key exclusion criteria (2 listed)
- Subjects with severe liver impairment
- Subjects who have weakened immune systems
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 |
|---|---|---|
| CP-690,550Single 10 mg dose of CP-690,550 | Drug | Normal hepatic function |
| CP-690,550Single 10 mg dose of CP-690,550 | Drug | Mild hepatic impairment |
| CP-690,550Single 10 mg dose of CP-690,550 | Drug | Moderate hepatic impairment |
Primary outcome
Pharmacokinetics of CP-690,550 in subjects with hepatic impairment compared to subjects with normal hepatic function
Time frame: 3 days
1 secondary outcome
Safety and tolerability of CP-690,550 in subjects with hepatic impairment compared to subjects with normal hepatic function
Time frame: 10-14 days
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 Feb 2010.
- Derived from this study: PubMed 27129117Lawendy N, Lamba M, Chan G, Wang R, Alvey CW, Krishnaswami S. The effect of mild and moderate hepatic impairment on the pharmacokinetics of tofacitinib, an orally active Janus kinase inhibitor. Clin Pharmacol Drug Dev. 2014 Nov;3(6):421-7. doi: 10.1002/cpdd.143. Epub 2014 Oct 1.
- 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 CP-690,550 in people with Hepatic Insufficiency, run by Pfizer 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 1 inclusion and 2 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 Feb 2010. 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?
Pharmacokinetics of CP-690,550 in subjects with hepatic impairment compared to subjects with normal hepatic function (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00969813, which also lists 1 linked publication.
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 Feb 2010.