CachexiaPhase 1NCT01262690
A Study In Healthy Subjects Of Single Doses of PF-05230901 Injected Under The Skin
A Phase 1 study testing PF-05230901 in people with Cachexia, run by Pfizer at 1 site in United States.
Trial summary
This study will examine whether a single dose of PF-05230901 is safe and well tolerated when given to healthy volunteers by injection under the skin. An additional objective is to measure the blood concentrations of PF-05230901. Each dose will be tested in a different group of subjects starting from the lowest dose. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cachexia
- What is being tested?
- PF-05230901
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects
Who cannot join
- History of seizures, including childhood seizures.
- History of movement disorders or related neurological conditions.
- History of head trauma associated with loss of consciousness.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
New Haven, Connecticut, 06511
About this study
Official title: A Phase 1 Ascending Single Dose Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-05230901 Administered Subcutaneously To Healthy Subjects
This study will examine whether a single dose of PF-05230901 is safe and well tolerated when given to healthy volunteers by injection under the skin. An additional objective is to measure the blood concentrations of PF-05230901. Each dose will be tested in a different group of subjects starting from the lowest dose.
- Conditions
- Cachexia
- Being tested
- PF-05230901
- Keywords
- First-in-human (FIH), Single Ascending Dose (SAD) Study, TAM-163, PF-05230901, Cachexia
- Medical subject headings
- Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-05230901Drug
Also called TAM-153
Single ascending doses of PF-05230901 in separate cohorts of subjects; each cohort consists of 6 subjects treated with PF-05230901 and 3 subjects treated with placebo.
PF-05230901Drug
Also called TAM-163
Single dose SC
| Study group | Role | What they receive |
|---|---|---|
| Dose | Experimental | 6 treated, 3 placebos Receives: Drug: PF-05230901 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events.
Measured: 35 days
Incidence and severity of clinical laboratory abnormalities.
Measured: 35 days
Mean change from baseline in vital signs.
Measured: 35 days
Mean change from baseline in 12-lead electrocardiogram (ECG) parameters.
Measured: 35 days
Incidence and severity of findings during the neurological examination.
Measured: 35 days
Secondary outcomes (3)
Plasma concentrations
Measured: 14 days
Anti-drug antibodies
Measured: 35 days
Appetite and food consumption
Measured: 13 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionSep 2011
- Study completionSep 2011
Why it stopped: The study was terminated on 21-Sept-2011 due to the emergent safety concern of sensory symptoms.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CachexiaStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01262690
- Sponsor's protocol ID
- B2291001
- Other IDs
- TAM-163 FIH Study; 3279K1-1000
- Status last verified
- Oct 2011
- First submitted
- 23 Nov 2010
- Last updated
- 12 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Ascending Single Dose Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-05230901 Administered Subcutaneously To Healthy Subjects
- ClinicalTrials.gov ID
- NCT01262690
- Acronym / sponsor ID
- B2291001
- Conditions
- Cachexia
- Keywords
- First-in-human (FIH), Single Ascending Dose (SAD) Study, TAM-163, PF-05230901, Cachexia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated on 21-Sept-2011 due to the emergent safety concern of sensory symptoms.
- Enrolment
- 44 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 17 Dec 2010 (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 will examine whether a single dose of PF-05230901 is safe and well tolerated when given to healthy volunteers by injection under the skin. An additional objective is to measure the blood concentrations of PF-05230901. Each dose will be tested in a different group of subjects starting from the lowest dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose | Experimental | Drug: PF-052309016 treated, 3 placebos |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy subjects
Key exclusion criteria (3 listed)
- History of seizures, including childhood seizures.
- History of movement disorders or related neurological conditions.
- History of head trauma associated with loss of consciousness.
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 |
|---|---|---|
| PF-05230901Also: TAM-153Single ascending doses of PF-05230901 in separate cohorts of subjects; each cohort consists of 6 subjects treated with PF-05230901 and 3 subjects treated with placebo. | Drug | Dose |
| PF-05230901Also: TAM-163Single dose SC | Drug | Dose |
Primary outcome
Incidence and severity of adverse events.
Time frame: 35 days
Incidence and severity of clinical laboratory abnormalities.
Time frame: 35 days
Mean change from baseline in vital signs.
Time frame: 35 days
Mean change from baseline in 12-lead electrocardiogram (ECG) parameters.
Time frame: 35 days
Incidence and severity of findings during the neurological examination.
Time frame: 35 days
3 secondary outcomes
Plasma concentrations
Time frame: 14 days
Anti-drug antibodies
Time frame: 35 days
Appetite and food consumption
Time frame: 13 days
Results and safety
The study was stopped early (reason given: The study was terminated on 21-Sept-2011 due to the emergent safety concern of sensory symptoms.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 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 PF-05230901 in people with Cachexia, 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 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: stopped early, as of the sponsor's last update on 12 Oct 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 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 was stopped early (reason given: The study was terminated on 21-Sept-2011 due to the emergent safety concern of sensory symptoms.). Results are not available in the source record.
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?
Incidence and severity of adverse events. (time frame: 35 days). The study lists 5 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 12 Oct 2011.