Back to resultsA Study To Assess The Safety, Tolerability, And Pharmacokinetics (PK) Of Multiple Doses Of PF-06865571 In Healthy, Including Overweight And Obese, Adult Subjects
Primary Purpose
Healthy Subjects
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
PF-06865571
PF-06865571
PF-06865571
PF-06865571
PF-06865571
PF-06865571
PF-06865571
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Healthy Subjects
Eligibility Criteria
Inclusion Criteria:
- Healthy males and female of non-childbearing potential;
- Age of 18-55, inclusive;
- Body Mass Index 22.5 to 35.4 kg/m2, inclusive;
- Body weight greater than 50 kg;
- Not on any prescription or non-prescription drugs within 7 days or 5 half-lives prior to first dose.
Exclusion Criteria:
- Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergises, but excluding untreated, asymptomatic, seasonal allergies at time of dosing);
- Subjects with fasting LDL-C level >190 mg/dL following an overnight fast of at least 10 hours, at the Screening visit, confirmed by a single repeat, if deemed necessary.
- Subjects with fasting TG level >400 mg/dL following an overnight fast of at least 10 hours, at the Screening visit, confirmed by a single repeat, if deemed necessary.
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- A positive urine drug test.
- History of regular alcohol consumption exceeding 7 drinks/week for female subjects or 14 drinks/week for male subjects (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 before screening.
- Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product (whichever is longer).
- Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day or 2 chews of tobacco per day.
- Pregnant female subjects; breastfeeding female subjects; male subjects with partners currently pregnant; fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
- Unwilling or unable to comply with the criteria in the Lifestyle Requirements section of this protocol.
- Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Sites / Locations
- Pfizer New Haven Clinical Research Unit
- Pfizer Clinical Research Unit
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Cohort 1_90mg and Matching Placebo
Cohort 2_300mg and Matching Placebo
Cohort 3_900mg and Matching Placebo
Cohort 4_1800mg and Matching Placebo
Cohort 5_3000mg and Matching Placebo
Optional Cohort 6_TBD mg and Matching Placebo
Optional Cohort 7_TBD mg and Matching Placebo
Arm Description
Outcomes
Primary Outcome Measures
Number of subjects with adverse events (AEs)
Number of participants with reported adverse events
Number of subjects with laboratory tests findings of potential clinical importance
Number of participants with potentially clinically important laboratory test findings
Number of subjects with electrocardiogram (ECG) findings of potential clinical importance
Number of participants with potentially clinically important ECG findings
Number of subjects with vital signs findings of potential clinical importance
Number of participants with potentially clinically important vital sign measurements
Secondary Outcome Measures
Maximum Observed Plasma Concentration (Cmax) for PF-06865571
AUCtau for PF-06865571
Area under the concentration-time curve calculated by linear trapezoidal rule from time zero to the end of the dosing interval (i.e., 24 h) at steady state.
Time to Reach Maximum Observed Concentration for PF-06865571
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Dose normalized Cmax for PF-06865571
Following log-transformation, dose normalized Cmax will be analysed using a mixed model appropriate to the study design.
Amount of unchanged drug recovered in urine during the dosing interval (Aetau) for PF-06865571
Sum of [urine concentration * sample volume] for each collection over the dosing interval
Percent of dose recovered in urine as unchanged drug (Aetau %) for PF-06865571
100* Aetau/Dose
Renal clearance (CLr) for PF-06865571
Aetau/AUCtau
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03230383
Brief Title
A Study To Assess The Safety, Tolerability, And Pharmacokinetics (PK) Of Multiple Doses Of PF-06865571 In Healthy, Including Overweight And Obese, Adult Subjects
Official Title
A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Multiple Escalating Oral Doses Of PF-06865571 In Healthy, Including Overweight And Obese, Adult Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
May 3, 2018 (Actual)
Study Completion Date
May 3, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This will be an investigator- and subject-blinded (sponsor open), randomized, placebo controlled, sequential, ascending, multiple oral dose study, with 5 planned cohorts (optional sixth and seventh cohorts). A total of approximately 50 (if 5 cohorts), 60 (if 6 cohorts), and up to 70 (if 7 cohorts) subjects will be randomized in this study. Subjects in each cohort will be randomized to receive PF-06865571 or matching placebo with approximately 10 subjects dosed in each cohort.
For a given subject in any cohort, the total study duration from screening to follow-up phone call will be between approximately 7 to 11 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Subjects
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1_90mg and Matching Placebo
Arm Type
Experimental
Arm Title
Cohort 2_300mg and Matching Placebo
Arm Type
Experimental
Arm Title
Cohort 3_900mg and Matching Placebo
Arm Type
Experimental
Arm Title
Cohort 4_1800mg and Matching Placebo
Arm Type
Experimental
Arm Title
Cohort 5_3000mg and Matching Placebo
Arm Type
Experimental
Arm Title
Optional Cohort 6_TBD mg and Matching Placebo
Arm Type
Experimental
Arm Title
Optional Cohort 7_TBD mg and Matching Placebo
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PF-06865571
Intervention Description
Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.
Intervention Type
Drug
Intervention Name(s)
PF-06865571
Intervention Description
Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.
Intervention Type
Drug
Intervention Name(s)
PF-06865571
Intervention Description
Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.
Intervention Type
Drug
Intervention Name(s)
PF-06865571
Intervention Description
Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.
Intervention Type
Drug
Intervention Name(s)
PF-06865571
Intervention Description
Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.
Intervention Type
Drug
Intervention Name(s)
PF-06865571
Intervention Description
Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.
Intervention Type
Drug
Intervention Name(s)
PF-06865571
Intervention Description
Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching Placebo for PF-06865571 for each cohort.
Primary Outcome Measure Information:
Title
Number of subjects with adverse events (AEs)
Description
Number of participants with reported adverse events
Time Frame
Baseline up to 35 days after last dose of study medication
Title
Number of subjects with laboratory tests findings of potential clinical importance
Description
Number of participants with potentially clinically important laboratory test findings
Time Frame
Baseline (Day 0) up to 24 days after last dose of study medication
Title
Number of subjects with electrocardiogram (ECG) findings of potential clinical importance
Description
Number of participants with potentially clinically important ECG findings
Time Frame
Baseline (Day 0) up to 24 days after last dose of study medication
Title
Number of subjects with vital signs findings of potential clinical importance
Description
Number of participants with potentially clinically important vital sign measurements
Time Frame
Baseline (Day 0) up to 24 days after last dose of study medication
Secondary Outcome Measure Information:
Title
Maximum Observed Plasma Concentration (Cmax) for PF-06865571
Time Frame
0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Days 1, 7, and 14
Title
AUCtau for PF-06865571
Description
Area under the concentration-time curve calculated by linear trapezoidal rule from time zero to the end of the dosing interval (i.e., 24 h) at steady state.
Time Frame
0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Days 1, 7, and 14
Title
Time to Reach Maximum Observed Concentration for PF-06865571
Description
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame
0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Days 1, 7, and 14
Title
Dose normalized Cmax for PF-06865571
Description
Following log-transformation, dose normalized Cmax will be analysed using a mixed model appropriate to the study design.
Time Frame
0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Days 1, 7, and 14
Title
Amount of unchanged drug recovered in urine during the dosing interval (Aetau) for PF-06865571
Description
Sum of [urine concentration * sample volume] for each collection over the dosing interval
Time Frame
0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Day 14
Title
Percent of dose recovered in urine as unchanged drug (Aetau %) for PF-06865571
Description
100* Aetau/Dose
Time Frame
0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Day 14
Title
Renal clearance (CLr) for PF-06865571
Description
Aetau/AUCtau
Time Frame
0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Day 14
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 males and female of non-childbearing potential;
Age of 18-55, inclusive;
Body Mass Index 22.5 to 35.4 kg/m2, inclusive;
Body weight greater than 50 kg;
Not on any prescription or non-prescription drugs within 7 days or 5 half-lives prior to first dose.
Exclusion Criteria:
Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergises, but excluding untreated, asymptomatic, seasonal allergies at time of dosing);
Subjects with fasting LDL-C level >190 mg/dL following an overnight fast of at least 10 hours, at the Screening visit, confirmed by a single repeat, if deemed necessary.
Subjects with fasting TG level >400 mg/dL following an overnight fast of at least 10 hours, at the Screening visit, confirmed by a single repeat, if deemed necessary.
Any condition possibly affecting drug absorption (eg, gastrectomy).
A positive urine drug test.
History of regular alcohol consumption exceeding 7 drinks/week for female subjects or 14 drinks/week for male subjects (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 before screening.
Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product (whichever is longer).
Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day or 2 chews of tobacco per day.
Pregnant female subjects; breastfeeding female subjects; male subjects with partners currently pregnant; fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
Unwilling or unable to comply with the criteria in the Lifestyle Requirements section of this protocol.
Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
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 New Haven Clinical Research Unit
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Pfizer Clinical Research Unit
City
Brussels
ZIP/Postal Code
B-1070
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=C2541002&StudyName=A+Phase+1%2C+Randomized%2C+Double+Blind%2C+Placebo+Controlled+Study+To+Assess+The+Safety%2C+Tolerability%2C+And+Pharmacokinetics+Of+Multiple+Escalating+Oral+Doses+Of+Pf+06865571+In+Otherwise+Healthy%2C+Adult+Subjects
Description
To obtain contact information for a study center near you, click here.
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=C2541002&StudyName=A+Phase+1%2C+Randomized%2C+Double-blind%2C+Placebo-controlled+Study+To+Assess+The+Safety%2C+Tolerability%2C+And+Pharmacokinetics+Of+Multiple+Escalating+Oral+Doses+Of+Pf-06865571+In+Healthy%2C+Including+Overweight+And+Obese%2C+Adult+Subjects
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
A Study To Assess The Safety, Tolerability, And Pharmacokinetics (PK) Of Multiple Doses Of PF-06865571 In Healthy, Including Overweight And Obese, Adult Subjects
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