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A Single Oral Dose Study Of PF-06427878 In Healthy Adult Subjects

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ClinicalTrials.gov Identifier: NCT02208284
Recruitment Status : Completed
First Posted : August 5, 2014
Last Update Posted : March 4, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
PF-06427878 is a new compound proposed for the treatment of hyperlipidemia. The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single oral doses of PF-06427878 in healthy adult subjects.

Condition or disease Intervention/treatment Phase
Healthy Drug: PF-06427878 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Single Escalating Oral Doses Of Pf-06427878 Co-administered With Meal In Healthy Adult Subjects
Study Start Date : August 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Arm Intervention/treatment
Experimental: Cohort 1-PF-06427878 or placebo
Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK.
Drug: PF-06427878
PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.

Drug: Placebo
PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.

Experimental: Cohort 2-PF-06427878 or placebo
Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK.
Drug: PF-06427878
PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.

Drug: Placebo
PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.

Experimental: Cohort 3-PF-06427878 or placebo
Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK.
Drug: PF-06427878
PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.

Drug: Placebo
PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.




Primary Outcome Measures :
  1. Assessment of adverse events (AEs). [ Time Frame: 0-48 h post dose ]
  2. Assessment of clinical laboratory tests. [ Time Frame: 0-48 h post dose ]
  3. Assessment of vital signs (including blood pressure and pulse rate). [ Time Frame: 0-48 h post dose ]
  4. Assessment of cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG). [ Time Frame: 0-48 h post dose ]

Secondary Outcome Measures :
  1. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06427878 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

  2. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] for PF-06427878 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose ]
    AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).

  3. Maximum Observed Plasma Concentration (Cmax) for PF-06427878 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose ]
  4. Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose ]
  5. Apparent Oral Clearance (CL/F) for PF-06427878 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose ]
    Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

  6. Apparent Volume of Distribution (Vz/F) for PF-06427878 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose ]
    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.

  7. Plasma Decay Half-Life (t1/2) for PF-06427878 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and/or female subjects of non childbearing potential.
  • Body Mass Index (BMI) of 17.5 to 35.4 kg/m2; and a total body weight >50 kg
  • Subjects with fasting TG level of >=90 mg/dL and <=500 mg/dL following an overnight fast

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02208284


Locations
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United States, Connecticut
New Haven Clinical Research Unit
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02208284    
Other Study ID Numbers: B7871001
First Posted: August 5, 2014    Key Record Dates
Last Update Posted: March 4, 2015
Last Verified: March 2015
Keywords provided by Pfizer:
Single Ascending Dose
healthy subjects
Hyperlipidemia
Lipid Metabolism Disorders
Metabolic Diseases