Diabetes Mellitus, Type 2Phase 1NCT01372163
A Study Of PF-05190457 In Healthy Volunteers And Type-2 Diabetic Patients
A Phase 1 study of Diabetes Mellitus, Type 2, run by Pfizer at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the safety and tolerability of PF-05190457 after administration of multiple doses to healthy volunteers and Type 2 diabetic patients and to evaluate the plasma drug concentrations after multiple doses. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Apr 2012
- 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 males and females of non-childbearing potential between ages of 18 and 55 years, BMI of 18.5 to 30.5 kg/m^2, and weight between 50 and 100 kg, inclusive.
- Type 2 diabetic males and females of non-childbearing potential between ages of 18 and 55 years, BMI of 18.5 to 40.0 kg/m^2, weight between 50 and 150 kg, and HbA1c of 7.0-10.0%, inclusive.
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
- Additionally, type 2 diabetic patients who have history of diabetic complications with significant end-organ damage or pharmacologic treatment for diabetes in addition to metformin.
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 Placebo-Controlled Trial To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Multiple Ascending Doses Of PF-05190457 In Healthy And Type 2 Diabetic Adults
The purpose of the study is to evaluate the safety and tolerability of PF-05190457 after administration of multiple doses to healthy volunteers and Type 2 diabetic patients and to evaluate the plasma drug concentrations after multiple doses.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- PF-05190457 or Placebo
- Keywords
- Phase 1, Multiple Ascending Doses, Safety, Pharmacokinetics, Healthy Volunteers, Type 2 Diabetic Patients
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-05190457 or PlaceboDrug
Twice daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast and dinner in healthy volunteers.
PF-05190457 or PlaceboDrug
Twice daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast and dinner in healthy volunteers.
PF-05190457 or PlaceboDrug
Twice daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast and dinner in healthy volunteers.
PF-05190457 or PlaceboDrug
Twice daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast and dinner in healthy volunteers.
PF-05190457 or PlaceboDrug
Once daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast in healthy volunteers.
PF-05190457 or PlaceboDrug
Once daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast in healthy volunteers.
PF-05190457 or PlaceboDrug
Once (or twice) daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast (and dinner if twice) in Type 2 Diabetic patients.
| Study group | Role | What they receive |
|---|---|---|
| 2 mg PF-05190457 or Placebo BID | Experimental | Not described Receives: Drug: PF-05190457 or Placebo |
| 10 mg PF-05190457 or Placebo BID | Experimental | Not described Receives: Drug: PF-05190457 or Placebo |
| 40 mg PF-05190457 or Placebo BID | Experimental | Dose and dose frequency may be adjusted based on emerging safety and PK data. Receives: Drug: PF-05190457 or Placebo |
| 150 mg PF-05190457 or Placebo BID | Experimental | Dose and dose frequency may be adjusted based on emerging safety and PK data. Receives: Drug: PF-05190457 or Placebo |
| 5 mg PF-05190457 or Placebo QD | Experimental | Dose and dose frequency may be adjusted based on emerging safety and PK data. Receives: Drug: PF-05190457 or Placebo |
| 50 mg PF-05190457 or Placebo QD | Experimental | Dose and dose frequency may be adjusted based on emerging safety and PK data. Receives: Drug: PF-05190457 or Placebo |
| xxx mg PF-05190457 or Placebo | Experimental | Dose and dose frequency to be determined based on emerging safety and PK data. Receives: Drug: PF-05190457 or Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events as a measure of safety and tolerability.
Measured: 8 weeks
Secondary outcomes (8)
The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of Area Under the Curve (AUC) and its accumulation ratio on days 1, 13, and 14, as appropriate and the data permit.
Measured: 2 weeks
The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of Maximum Concentration (Cmax) on days 1, 13, and 14, as appropriate and the data permit.
Measured: 2 weeks
The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of Time of Maximum concentration (Tmax) on days 1, 13, and 14, as appropriate and the data permit.
Measured: 2 weeks
The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of the Minimum Amount of concentration (Cmin) on days 13 and 14, as appropriate and the data permit.
Measured: 2 weeks
The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of Elimination of half-life (t ½ ) on day 14, as the data permit.
Measured: 2 weeks
The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of apparent total clearance of the drug from plasma after oral administration (CL/F) on days 13 and 14, as the data permit.
Measured: 2 weeks
The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of apparent volume of distribution during terminal phase after non-intravenous administration (Vz/F) on days 13 and 14, as the data permit.
Measured: 2 weeks
Urinary recovery and renal clearance of PF-05190457 will be estimated via comparison of the plasma AUC and urinary excretion to provide AE0-τ, AE0-τ%, and CLR as the data permit.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionApr 2012
- Study completionApr 2012
Why it stopped: B3301002 was discontinued on 18 April 2012 for strategic reasons.There were no safety concerns leading to discontinuation of this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 35 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
- NCT01372163
- Sponsor's protocol ID
- B3301002
- Status last verified
- May 2012
- First submitted
- 10 Jun 2011
- Last updated
- 23 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Placebo-Controlled Trial To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Multiple Ascending Doses Of PF-05190457 In Healthy And Type 2 Diabetic Adults
- ClinicalTrials.gov ID
- NCT01372163
- Acronym / sponsor ID
- B3301002
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Phase 1, Multiple Ascending Doses, Safety, Pharmacokinetics, Healthy Volunteers, Type 2 Diabetic Patients
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: B3301002 was discontinued on 18 April 2012 for strategic reasons.There were no safety concerns leading to discontinuation of this study.
- Enrolment
- 35 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 13 Jun 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.
The purpose of the study is to evaluate the safety and tolerability of PF-05190457 after administration of multiple doses to healthy volunteers and Type 2 diabetic patients and to evaluate the plasma drug concentrations after multiple doses.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 2 mg PF-05190457 or Placebo BID | Experimental | Drug: PF-05190457 or Placebo |
| 10 mg PF-05190457 or Placebo BID | Experimental | Drug: PF-05190457 or Placebo |
| 40 mg PF-05190457 or Placebo BID | Experimental | Drug: PF-05190457 or PlaceboDose and dose frequency may be adjusted based on emerging safety and PK data. |
| 150 mg PF-05190457 or Placebo BID | Experimental | Drug: PF-05190457 or PlaceboDose and dose frequency may be adjusted based on emerging safety and PK data. |
| 5 mg PF-05190457 or Placebo QD | Experimental | Drug: PF-05190457 or PlaceboDose and dose frequency may be adjusted based on emerging safety and PK data. |
| 50 mg PF-05190457 or Placebo QD | Experimental | Drug: PF-05190457 or PlaceboDose and dose frequency may be adjusted based on emerging safety and PK data. |
| xxx mg PF-05190457 or Placebo | Experimental | Drug: PF-05190457 or PlaceboDose and dose frequency to be determined based on emerging safety and PK data. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy males and females of non-childbearing potential between ages of 18 and 55 years, BMI of 18.5 to 30.5 kg/m^2, and weight between 50 and 100 kg, inclusive.
- Type 2 diabetic males and females of non-childbearing potential between ages of 18 and 55 years, BMI of 18.5 to 40.0 kg/m^2, weight between 50 and 150 kg, and HbA1c of 7.0-10.0%, inclusive.
Key exclusion criteria (2 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
- Additionally, type 2 diabetic patients who have history of diabetic complications with significant end-organ damage or pharmacologic treatment for diabetes in addition to metformin.
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-05190457 or PlaceboTwice daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast and dinner in healthy volunteers. | Drug | 2 mg PF-05190457 or Placebo BID |
| PF-05190457 or PlaceboTwice daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast and dinner in healthy volunteers. | Drug | 10 mg PF-05190457 or Placebo BID |
| PF-05190457 or PlaceboTwice daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast and dinner in healthy volunteers. | Drug | 40 mg PF-05190457 or Placebo BID |
| PF-05190457 or PlaceboTwice daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast and dinner in healthy volunteers. | Drug | 150 mg PF-05190457 or Placebo BID |
| PF-05190457 or PlaceboOnce daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast in healthy volunteers. | Drug | 5 mg PF-05190457 or Placebo QD |
| PF-05190457 or PlaceboOnce daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast in healthy volunteers. | Drug | 50 mg PF-05190457 or Placebo QD |
| PF-05190457 or PlaceboOnce (or twice) daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast (and dinner if twice) in Type 2 Diabetic patients. | Drug | xxx mg PF-05190457 or Placebo |
Primary outcome
Number of participants with Adverse Events as a measure of safety and tolerability.
Time frame: 8 weeks
8 secondary outcomes
The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of Area Under the Curve (AUC) and its accumulation ratio on days 1, 13, and 14, as appropriate and the data permit.
Time frame: 2 weeks
The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of Maximum Concentration (Cmax) on days 1, 13, and 14, as appropriate and the data permit.
Time frame: 2 weeks
The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of Time of Maximum concentration (Tmax) on days 1, 13, and 14, as appropriate and the data permit.
Time frame: 2 weeks
The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of the Minimum Amount of concentration (Cmin) on days 13 and 14, as appropriate and the data permit.
Time frame: 2 weeks
The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of Elimination of half-life (t ½ ) on day 14, as the data permit.
Time frame: 2 weeks
The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of apparent total clearance of the drug from plasma after oral administration (CL/F) on days 13 and 14, as the data permit.
Time frame: 2 weeks
The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of apparent volume of distribution during terminal phase after non-intravenous administration (Vz/F) on days 13 and 14, as the data permit.
Time frame: 2 weeks
Urinary recovery and renal clearance of PF-05190457 will be estimated via comparison of the plasma AUC and urinary excretion to provide AE0-τ, AE0-τ%, and CLR as the data permit.
Time frame: 2 weeks
Results and safety
The study was stopped early (reason given: B3301002 was discontinued on 18 April 2012 for strategic reasons.There were no safety concerns leading to discontinuation of this study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2012.
- 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 of Diabetes Mellitus, Type 2, 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 2 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: stopped early, as of the sponsor's last update on 23 May 2012. 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: B3301002 was discontinued on 18 April 2012 for strategic reasons.There were no safety concerns leading to discontinuation of this study.). 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?
Number of participants with Adverse Events as a measure of safety and tolerability. (time frame: 8 weeks). 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 May 2012.