ObesityPhase 1NCT00645021
Study Examining The Effect Of Hepatic Impairment On Safety, Toleration And How The Body Processes An Experimental Drug
A Phase 1 study testing CP-945,598 in people with Obesity and Hepatic Insufficiency, run by Pfizer at 2 sites in United States.
Trial summary
CP-945,598 is eliminated following extensive metabolism. Decrease hepatic function can affect its elimination from the body via metabolism. This study will therefore compare the pharmacokinetics (time course of drug concentrations in the body), safety, and tolerability of CP-945,598 in patients with mild and moderate… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Hepatic Insufficiency
- What is being tested?
- CP-945,598
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2008to Oct 2008
- 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
- Healthy:Matched for age (± 5 years), weight (± 10 kg), and gender (±2 subjects per gender)
- Subjects with hepatic disease: 1. mild impairment (child-pugh score 5-6), moderate (child-pugh score 7-9). 2. stable hepatic disease: no changes in the last 30 days. 3. stable dose of medication and/or treatment.
Who cannot join
- All subjects: Non-prescribed use of drugs of abuse/recreational drugs; recent treatment with experimental drugs or herbal experiments; ECG and blood pressure falling outside of protocol-specified limits; history of regular tobacco use exceeding protocol-specified limits
- Normal subjects: medically important health conditions; recent use of prescription or non-prescription medications; history of regular alcohol use exceeding protocol-specified limits
- Subjects with hepatic disease: child-puge score greater than 9; hepatic carcinoma and hepatorenal syndrome;Undergone porta-caval shunt surgery; History of GI hemorrhage due to esophageal varices or peptic ulcers less than 1 month prior to study entry; significant hepatic encephalopathy; severe ascites and/or pleural effusion; Positive blood alcohol test/alcohol breathalyzer at screening or on Day 0.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pfizer Investigational Site
Miami, Florida, 33169
Pfizer Investigational Site
Orlando, Florida, 32809
About this study
Official title: A Phase 1, Open-Label, Parallel Group, Multiple-Dose Study To Evaluate The Pharmacokinetics, Safety And Toleration Of CP-945,598 Administered To Subjects With Impaired And Normal Hepatic Function
CP-945,598 is eliminated following extensive metabolism. Decrease hepatic function can affect its elimination from the body via metabolism. This study will therefore compare the pharmacokinetics (time course of drug concentrations in the body), safety, and tolerability of CP-945,598 in patients with mild and moderate hepatic impairment and healthy control subjects.
- Conditions
- Obesity, Hepatic Insufficiency
- Being tested
- CP-945,598
- Medical subject headings
- Obesity, Hepatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-945,598Drug
Administration of CP-945,598 in subjects with mild hepatic function
CP-945,598Drug
Administration of CP-945,598 in subjects with moderate hepatic function
CP-945,598Drug
Administration of CP-945,598 in subjects with normal hepatic function
| Study group | Role | What they receive |
|---|---|---|
| Mild hepatic function | Experimental | Not described Receives: Drug: CP-945,598 |
| Moderate hepatic function | Experimental | Not described Receives: Drug: CP-945,598 |
| Normal hepatic function | Experimental | Not described Receives: Drug: CP-945,598 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of drug and metabolite concentrations in serum collected at various times over 24 hour dosing interval on Days 1 and 14, before daily dose on days 5-7, 13, following stopping of drug treatment on days 15-18, 21, 28, and 35
Measured: 14 days
Secondary outcomes (4)
Safety laboratory tests (chemistry, hematology, urinalysis) on days 0, 7, 15, 35
Measured: 14 days
Adverse event monitoring throughout duration of the study
Measured: 14 days
Vital signs (blood pressure, heart rate and respiratory rate) on days 1, 7, and 14
Measured: 14 days
ECGs on Days 1, 7, and 14
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2008 (estimated)
- Study startApr 2008
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT00645021
- Sponsor's protocol ID
- A5351029
- Status last verified
- Nov 2008
- First submitted
- 21 Mar 2008
- Last updated
- 27 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Parallel Group, Multiple-Dose Study To Evaluate The Pharmacokinetics, Safety And Toleration Of CP-945,598 Administered To Subjects With Impaired And Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT00645021
- Acronym / sponsor ID
- A5351029
- Conditions
- Obesity, Hepatic Insufficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 27 Mar 2008 (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.
CP-945,598 is eliminated following extensive metabolism. Decrease hepatic function can affect its elimination from the body via metabolism. This study will therefore compare the pharmacokinetics (time course of drug concentrations in the body), safety, and tolerability of CP-945,598 in patients with mild and moderate hepatic impairment and healthy control subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild hepatic function | Experimental | Drug: CP-945,598 |
| Moderate hepatic function | Experimental | Drug: CP-945,598 |
| Normal hepatic function | Experimental | Drug: CP-945,598 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy:Matched for age (± 5 years), weight (± 10 kg), and gender (±2 subjects per gender)
- Subjects with hepatic disease: 1. mild impairment (child-pugh score 5-6), moderate (child-pugh score 7-9). 2. stable hepatic disease: no changes in the last 30 days. 3. stable dose of medication and/or treatment.
Key exclusion criteria (3 listed)
- All subjects: Non-prescribed use of drugs of abuse/recreational drugs; recent treatment with experimental drugs or herbal experiments; ECG and blood pressure falling outside of protocol-specified limits; history of regular tobacco use exceeding protocol-specified limits
- Normal subjects: medically important health conditions; recent use of prescription or non-prescription medications; history of regular alcohol use exceeding protocol-specified limits
- Subjects with hepatic disease: child-puge score greater than 9; hepatic carcinoma and hepatorenal syndrome;Undergone porta-caval shunt surgery; History of GI hemorrhage due to esophageal varices or peptic ulcers less than 1 month prior to study entry; significant hepatic encephalopathy; severe ascites and/or pleural effusion; Positive blood alcohol test/alcohol breathalyzer at screening or on Day 0.
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-945,598Administration of CP-945,598 in subjects with mild hepatic function | Drug | Mild hepatic function |
| CP-945,598Administration of CP-945,598 in subjects with moderate hepatic function | Drug | Moderate hepatic function |
| CP-945,598Administration of CP-945,598 in subjects with normal hepatic function | Drug | Normal hepatic function |
Primary outcome
Measurement of drug and metabolite concentrations in serum collected at various times over 24 hour dosing interval on Days 1 and 14, before daily dose on days 5-7, 13, following stopping of drug treatment on days 15-18, 21, 28, and 35
Time frame: 14 days
4 secondary outcomes
Safety laboratory tests (chemistry, hematology, urinalysis) on days 0, 7, 15, 35
Time frame: 14 days
Adverse event monitoring throughout duration of the study
Time frame: 14 days
Vital signs (blood pressure, heart rate and respiratory rate) on days 1, 7, and 14
Time frame: 14 days
ECGs on Days 1, 7, and 14
Time frame: 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 27 Aug 2009.
- 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
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 CP-945,598 in people with Obesity and Hepatic Insufficiency, run by Pfizer 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 2 inclusion and 3 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 27 Aug 2009. 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?
Measurement of drug and metabolite concentrations in serum collected at various times over 24 hour dosing interval on Days 1 and 14, before daily dose on days 5-7, 13, following stopping of drug treatment on days 15-18, 21, 28, and 35 (time frame: 14 days). 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 27 Aug 2009.