Diabetes Mellitus, Type 2Phase 1NCT01202266
A Multiple Dose Study Of PF-05161704 In Healthy Volunteers
A Phase 1 study of Diabetes Mellitus, Type 2, run by Pfizer at 1 site in United States.
Trial summary
The primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of multiple escalating oral doses of PF-05161704 in healthy volunteers 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
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Dec 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and/or female (non-childbearing potential) subjects between the ages of 18 and 55 years, inclusive
- Body Mass Index (BMI) of 24.5 to 35.5 kg/m2 and a total body weight >50 kg (110 lbs.)
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Any condition possibly affecting drug absorption (e.g., gastrectomy).
- History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
- History or evidence of habitual use of tobacco or nicotine containing products within 3 months of screening or positive cotinine test at screening or Day -1.
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 Study To Assess The Safety, Tolerability And Pharmacokinetics Of Pf-05161704 After Administration Of Multiple Escalating Oral Doses In Healthy Volunteers
The primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of multiple escalating oral doses of PF-05161704 in healthy volunteers
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- PF-05161704 or Placebo
- Keywords
- Multiple Ascending Dose, Phase 1, Safety and Tolerability, PK, Healthy Subjects
- 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-05161704 or PlaceboDrug
PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner
PF-05161704 or PlaceboDrug
PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner
PF-05161704 or PlaceboDrug
PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner
PF-05161704 or PlaceboDrug
PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner
PF-05161704 or PlaceboDrug
PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner or once daily for 14 days immediately after breakfast
PF-05161704 or PlaceboDrug
PF-05161704 and Placebo (3:1) oral dosing Suspensions administered once daily for 14 days immediately after breakfast
PF-05161704 or PlaceboDrug
PF-05161704 and Placebo (3:1) oral dosing Suspensions administered once daily for 14 days immediately after breakfast
PF-05161704 or PlaceboDrug
PF-05161704 and Placebo (3:1) oral dosing Suspensions administered once daily for 14 days immediately after breakfast
| Study group | Role | What they receive |
|---|---|---|
| 5 mg PF-05161704 or Placebo | Experimental | Not described Receives: Drug: PF-05161704 or Placebo |
| 15 mg PF-05161704 or Placebo | Experimental | Planned dose: may be modified based on emerging PK and safety data. Receives: Drug: PF-05161704 or Placebo |
| 50 mg PF-05161704 or Placebo | Experimental | Planned dose: may be modified based on emerging PK and safety data. Receives: Drug: PF-05161704 or Placebo |
| 150 mg PF-05161704 or Placebo | Experimental | Planned dose: may be modified based on emerging PK and safety data. Receives: Drug: PF-05161704 or Placebo |
| xx mg PF-05161704 or Placebo | Experimental | Planned dose and dosing regimen will be determined based on emerging PK and safety data. Receives: Drug: PF-05161704 or Placebo |
| xxx mg PF-05161704 or Placebo | Experimental | Dose will be determined based on data from previous 5 arms. Receives: Drug: PF-05161704 or Placebo |
| yy mg PF-05161704 or Placebo | Experimental | Dose will be determined based on data from previous 6 arms Receives: Drug: PF-05161704 or Placebo |
| yyy mg PF-05161704 or Placebo | Experimental | Dose will be determined based on data from previous 7 arms. Receives: Drug: PF-05161704 or Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability endpoints evaluated by adverse event monitoring, laboratory values, cardiovascular monitoring
Measured: 2 weeks
Pharmacokinetic Endpoints: single dose and steady state pharmacokinetics of PF-05161704 and its metabolite PF-05200145. Urinary recovery will also be assessed for PF-05161704 and PF-05200145
Measured: 2 weeks
Secondary outcomes (2)
Pharmacodynamic Endpoints: Absolute value and change from Day 0 baseline in postprandial GLP-1. Postprandial plasma PYY, triglycerides and apoB48. Absolute value and change from baseline in apoB100 and VLDL
Measured: 2 weeks
Exploratory Parameters: absolute value and change from Day 0 baseline in concentrations of fasting serum lipids and body weight
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 posted15 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2010
- Study completionDec 2010
Why it stopped: The study was terminated on October 29, 2010 due to gastrointestinal adverse events.
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 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
- NCT01202266
- Sponsor's protocol ID
- B2911002
- Status last verified
- Mar 2011
- First submitted
- 13 Sep 2010
- Last updated
- 11 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Placebo-Controlled Study To Assess The Safety, Tolerability And Pharmacokinetics Of Pf-05161704 After Administration Of Multiple Escalating Oral Doses In Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01202266
- Acronym / sponsor ID
- B2911002
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Multiple Ascending Dose, Phase 1, Safety and Tolerability, PK, Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated on October 29, 2010 due to gastrointestinal adverse events.
- Enrolment
- 32 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 15 Sep 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.
The primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of multiple escalating oral doses of PF-05161704 in healthy volunteers
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 5 mg PF-05161704 or Placebo | Experimental | Drug: PF-05161704 or Placebo |
| 15 mg PF-05161704 or Placebo | Experimental | Drug: PF-05161704 or PlaceboPlanned dose: may be modified based on emerging PK and safety data. |
| 50 mg PF-05161704 or Placebo | Experimental | Drug: PF-05161704 or PlaceboPlanned dose: may be modified based on emerging PK and safety data. |
| 150 mg PF-05161704 or Placebo | Experimental | Drug: PF-05161704 or PlaceboPlanned dose: may be modified based on emerging PK and safety data. |
| xx mg PF-05161704 or Placebo | Experimental | Drug: PF-05161704 or PlaceboPlanned dose and dosing regimen will be determined based on emerging PK and safety data. |
| xxx mg PF-05161704 or Placebo | Experimental | Drug: PF-05161704 or PlaceboDose will be determined based on data from previous 5 arms. |
| yy mg PF-05161704 or Placebo | Experimental | Drug: PF-05161704 or PlaceboDose will be determined based on data from previous 6 arms |
| yyy mg PF-05161704 or Placebo | Experimental | Drug: PF-05161704 or PlaceboDose will be determined based on data from previous 7 arms. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male and/or female (non-childbearing potential) subjects between the ages of 18 and 55 years, inclusive
- Body Mass Index (BMI) of 24.5 to 35.5 kg/m2 and a total body weight >50 kg (110 lbs.)
Key exclusion criteria (4 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Any condition possibly affecting drug absorption (e.g., gastrectomy).
- History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
- History or evidence of habitual use of tobacco or nicotine containing products within 3 months of screening or positive cotinine test at screening or 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 |
|---|---|---|
| PF-05161704 or PlaceboPF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner | Drug | 5 mg PF-05161704 or Placebo |
| PF-05161704 or PlaceboPF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner | Drug | 15 mg PF-05161704 or Placebo |
| PF-05161704 or PlaceboPF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner | Drug | 50 mg PF-05161704 or Placebo |
| PF-05161704 or PlaceboPF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner | Drug | 150 mg PF-05161704 or Placebo |
| PF-05161704 or PlaceboPF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner or once daily for 14 days immediately after breakfast | Drug | xx mg PF-05161704 or Placebo |
| PF-05161704 or PlaceboPF-05161704 and Placebo (3:1) oral dosing Suspensions administered once daily for 14 days immediately after breakfast | Drug | xxx mg PF-05161704 or Placebo |
| PF-05161704 or PlaceboPF-05161704 and Placebo (3:1) oral dosing Suspensions administered once daily for 14 days immediately after breakfast | Drug | yy mg PF-05161704 or Placebo |
| PF-05161704 or PlaceboPF-05161704 and Placebo (3:1) oral dosing Suspensions administered once daily for 14 days immediately after breakfast | Drug | yyy mg PF-05161704 or Placebo |
Primary outcome
Safety and tolerability endpoints evaluated by adverse event monitoring, laboratory values, cardiovascular monitoring
Time frame: 2 weeks
Pharmacokinetic Endpoints: single dose and steady state pharmacokinetics of PF-05161704 and its metabolite PF-05200145. Urinary recovery will also be assessed for PF-05161704 and PF-05200145
Time frame: 2 weeks
2 secondary outcomes
Pharmacodynamic Endpoints: Absolute value and change from Day 0 baseline in postprandial GLP-1. Postprandial plasma PYY, triglycerides and apoB48. Absolute value and change from baseline in apoB100 and VLDL
Time frame: 2 weeks
Exploratory Parameters: absolute value and change from Day 0 baseline in concentrations of fasting serum lipids and body weight
Time frame: 2 weeks
Results and safety
The study was stopped early (reason given: The study was terminated on October 29, 2010 due to gastrointestinal adverse events.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 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 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 4 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 11 Mar 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 October 29, 2010 due to gastrointestinal adverse events.). 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?
Safety and tolerability endpoints evaluated by adverse event monitoring, laboratory values, cardiovascular monitoring (time frame: 2 weeks). The study lists 2 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 11 Mar 2011.