A Single Dose Study Of PF-05161704 In Healthy Volunteers

NCT01183715

Last updated date
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Diabetes Mellitus, Type 2
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male and/or female (non child-bearing potential) subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).

- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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 (eg, 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 0 of period one

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Diabetes Mellitus, Type 2To Examine the Lung When People With Diabetes Take an Inhaled Form of Insulin, Compared to Subcutaneous Insulin.
NCT00143338
  1. Fresno, California
  2. San Antonio, Texas
ALL GENDERS
30 Years+
years
MULTIPLE SITES
Diabetes Mellitus, Type 2US Inhaled Insulin Dose Titration Study
NCT00246623
  1. Birmingham, Alabama
  2. Los Angeles, California
  3. New Britain, Connecticut
  4. Norwalk, Connecticut
  5. Hollywood, Florida
  6. Atlanta, Georgia
  7. Boise, Idaho
  8. Hayden, Idaho
  9. Baton Rouge, Louisiana
  10. Boston, Massachusetts
  11. Albany, New York
  12. Syracuse, New York
  13. Dallas, Texas
  14. El Paso, Texas
  15. San Antonio, Texas
  16. Bennington, Vermont
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Diabetes Mellitus, Type 2US Inhaled Insulin Therapeutic Choice Questionnaire Study
NCT00139763
  1. Chandler, Arizona
  2. Mesa, Arizona
  3. Phoenix, Arizona
  4. Phoenix, Arizona
  5. Tempe, Arizona
  6. Los Angeles, California
  7. San Diego, California
  8. Colorado Springs, Colorado
  9. Newark, Delaware
  10. Wilmington, Delaware
  11. Washington, District of Columbia
  12. Jacksonville, Florida
  13. Jacksonville, Florida
  14. Hayden, Idaho
  15. Nampa, Idaho
  16. Gurnee, Illinois
  17. Elkton, Maryland
  18. Detroit, Michigan
  19. Minneapolis, Minnesota
  20. St. Louis, Missouri
  21. Omaha, Nebraska
  22. Margate City, New Jersey
  23. Santa Fe, New Mexico
  24. New York, New York
  25. Morehead City, North Carolina
  26. Salisbury, North Carolina
  27. Statesville, North Carolina
  28. Winston-Salem, North Carolina
  29. Cincinnati, Ohio
  30. Portland, Oregon
  31. Portland, Oregon
  32. Orangeburg, South Carolina
  33. Simpsonville, South Carolina
  34. Arlington, Texas
  35. Dallas, Texas
  36. Madisonville, Texas
  37. San Antonio, Texas
  38. Bennington, Vermont
  39. Virginia Beach, Virginia
  40. Spokane, Washington
  41. Tacoma, Washington
  42. Milwaukee, Wisconsin
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Diabetes Mellitus, Type 212 Week Study Of PF-00734200 For The Treatment Of Type 2 Diabetes Mellitus In Subjects Treated With Metformin
NCT00473525
  1. Birmingham, Alabama
  2. Gilbert, Arizona
  3. Phoenix, Arizona
  4. Phoenix, Arizona
  5. Jonesboro, Arkansas
  6. Little Rock, Arkansas
  7. Carmichael, California
  8. Chula Vista, California
  9. Fair Oaks, California
  10. Los Angeles, California
  11. National City, California
  12. Paramount, California
  13. Roseville, California
  14. Sacramento, California
  15. DeFuniak Springs, Florida
  16. Destin, Florida
  17. Jacksonville, Florida
  18. New Port Richey, Florida
  19. New Port Richey, Florida
  20. Palm Harbor, Florida
  21. West Palm Beach, Florida
  22. Atlanta, Georgia
  23. Conyers, Georgia
  24. Chicago, Illinois
  25. Skokie, Illinois
  26. Skokie, Illinois
  27. Wheeling, Illinois
  28. Lexington, Kentucky
  29. Lexington, Kentucky
  30. Brockton, Massachusetts
  31. Worcester, Massachusetts
  32. Ann Arbor, Michigan
  33. Canton, Michigan
  34. Flint, Michigan
  35. Biloxi, Mississippi
  36. Picayune, Mississippi
  37. St. Louis, Missouri
  38. Omaha, Nebraska
  39. Las Vegas, Nevada
  40. Las Vegas, Nevada
  41. Las Vegas, Nevada
  42. Trenton, New Jersey
  43. Cary, North Carolina
  44. Raleigh, North Carolina
  45. Raleigh, North Carolina
  46. Marion, Ohio
  47. Oklahoma City, Oklahoma
  48. Oklahoma City, Oklahoma
  49. Carnegie, Pennsylvania
  50. East Providence, Rhode Island
  51. Bartlett, Tennessee
  52. Collierville, Tennessee
  53. Kingsport, Tennessee
  54. Dallas, Texas
  55. Houston, Texas
  56. Houston, Texas
  57. Houston, Texas
  58. Houston, Texas
  59. Irving, Texas
  60. San Antonio, Texas
  61. San Antonio, Texas
  62. Richmond, Virginia
  63. Virginia Beach, Virginia
  64. Milwaukee, Wisconsin
  65. Bogota, Cundinamarca
  66. Bogota, Cundinamarca
  67. Floridablanca, Santander
  68. Berlin,
  69. Giengen,
  70. Hamburg,
  71. Muenchen,
  72. Roma,
  73. Santiago de Compostela, La Coruña
  74. Alcala de Henares, Madrid
  75. Valencia,
  76. Valencia,
  77. Goteborg,
  78. Malmo,
  79. Stockholm,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Single Dose Study Of PF-05161704 In Healthy Volunteers
Official Title  ICMJE A Phase 1 Placebo-Controlled Study To Assess The Safety, Tolerability And Pharmacokinetics Of PF-05161704 After Administration Of Single Escalating Oral Doses Under Fed And Fasted Conditions In Healthy Volunteers
Brief Summary The primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single oral doses of PF-05161704 in healthy volunteers.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE Drug: PF-05161704 or placebo
PF-05161704 will be administered as an extemporaneously prepared suspension in the initially planned dose range of 1.5 mg to 300 mg. Correspondingly, placebo doses will be administered as suspension
Study Arms  ICMJE
  • Experimental: Cohort 1
    Subjects in Cohort 1 will receive 2 single doses of PF-05161704 and 1 placebo dose in random order in Periods 1-3; in addition, 1 dose of PF-05161704 will be administered in Period 4 in the fasted state.
    Intervention: Drug: PF-05161704 or placebo
  • Experimental: Cohort 2
    Subjects in Cohort 2 will receive 2 single doses of PF-05161704 and 1 placebo dose in random order in Periods 1-3
    Intervention: Drug: PF-05161704 or placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 13, 2010)
18
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or female (non child-bearing potential) subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria:

  • 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 (eg, 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 0 of period one
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01183715
Other Study ID Numbers  ICMJE B2911001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP