Back to resultsA Single Dose Study Of PF-05161704 In Healthy Volunteers
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PF-05161704 or placebo
PF-05161704 or placebo
Sponsored by
About this trial
This is an interventional basic science trial for Diabetes Mellitus, Type 2 focused on measuring Single Ascending Dose, Phase 1, Safety and Tolerability, PK, Healthy Subjects
Eligibility Criteria
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
Sites / Locations
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Arm Description
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.
Subjects in Cohort 2 will receive 2 single doses of PF-05161704 and 1 placebo dose in random order in Periods 1-3
Outcomes
Primary Outcome Measures
Safety and tolerability of escalating single oral doses of PF-05161704 in healthy subjects
Single dose pharmacokinetics of PF-05161704 and its metabolite PF-05200145
Secondary Outcome Measures
Preliminary pharmacodynamics of PF-05161704
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01183715
Brief Title
A Single Dose Study Of PF-05161704 In Healthy Volunteers
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Single Ascending Dose, Phase 1, Safety and Tolerability, PK, Healthy Subjects
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Subjects in Cohort 2 will receive 2 single doses of PF-05161704 and 1 placebo dose in random order in Periods 1-3
Intervention Type
Drug
Intervention Name(s)
PF-05161704 or placebo
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
PF-05161704 or placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Safety and tolerability of escalating single oral doses of PF-05161704 in healthy subjects
Time Frame
1 month
Title
Single dose pharmacokinetics of PF-05161704 and its metabolite PF-05200145
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Preliminary pharmacodynamics of PF-05161704
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2911001&StudyName=A%20Single%20Dose%20Study%20Of%20PF-05161704%20In%20Healthy%20Volunteers
Description
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A Single Dose Study Of PF-05161704 In Healthy Volunteers
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