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Trial record 1 of 1 for:    NCT03230383
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A Study To Assess The Safety, Tolerability, And Pharmacokinetics (PK) Of Multiple Doses Of PF-06865571 In Healthy, Including Overweight And Obese, Adult Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03230383
Recruitment Status : Completed
First Posted : July 26, 2017
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE July 24, 2017
First Posted Date  ICMJE July 26, 2017
Last Update Posted Date May 23, 2018
Actual Study Start Date  ICMJE August 1, 2017
Actual Primary Completion Date May 3, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2017)
  • Number of subjects with adverse events (AEs) [ Time Frame: Baseline up to 35 days after last dose of study medication ]
    Number of participants with reported adverse events
  • Number of subjects with laboratory tests findings of potential clinical importance [ Time Frame: Baseline (Day 0) up to 24 days after last dose of study medication ]
    Number of participants with potentially clinically important laboratory test findings
  • Number of subjects with electrocardiogram (ECG) findings of potential clinical importance [ Time Frame: Baseline (Day 0) up to 24 days after last dose of study medication ]
    Number of participants with potentially clinically important ECG findings
  • Number of subjects with vital signs findings of potential clinical importance [ Time Frame: Baseline (Day 0) up to 24 days after last dose of study medication ]
    Number of participants with potentially clinically important vital sign measurements
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03230383 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2017)
  • 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 ]
  • AUCtau 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 ]
    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 Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Days 1, 7, and 14 ]
    Time to Reach Maximum Observed Plasma Concentration (Tmax)
  • Dose normalized 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 ]
    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 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Day 14 ]
    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 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Day 14 ]
    100* Aetau/Dose
  • Renal clearance (CLr) for PF-06865571 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Day 14 ]
    Aetau/AUCtau
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Subjects
Intervention  ICMJE
  • Drug: PF-06865571
    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.
  • Drug: Placebo
    Matching Placebo for PF-06865571 for each cohort.
Study Arms  ICMJE
  • Experimental: Cohort 1_90mg and Matching Placebo
    Interventions:
    • Drug: PF-06865571
    • Drug: Placebo
  • Experimental: Cohort 2_300mg and Matching Placebo
    Interventions:
    • Drug: PF-06865571
    • Drug: Placebo
  • Experimental: Cohort 3_900mg and Matching Placebo
    Interventions:
    • Drug: PF-06865571
    • Drug: Placebo
  • Experimental: Cohort 4_1800mg and Matching Placebo
    Interventions:
    • Drug: PF-06865571
    • Drug: Placebo
  • Experimental: Cohort 5_3000mg and Matching Placebo
    Interventions:
    • Drug: PF-06865571
    • Drug: Placebo
  • Experimental: Optional Cohort 6_TBD mg and Matching Placebo
    Interventions:
    • Drug: PF-06865571
    • Drug: Placebo
  • Experimental: Optional Cohort 7_TBD mg and Matching Placebo
    Interventions:
    • Drug: PF-06865571
    • Drug: 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: May 4, 2018)
60
Original Estimated Enrollment  ICMJE
 (submitted: July 24, 2017)
70
Actual Study Completion Date  ICMJE May 3, 2018
Actual Primary Completion Date May 3, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
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 Belgium,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03230383
Other Study ID Numbers  ICMJE C2541002
2017-001649-28 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2018

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