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Single Dose Study of PF-06815345 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02654899
Recruitment Status : Terminated (Trial discontinued on 04Apr2016 as a strategic business decision not to pursue the indication. Decision to terminate not due to safety or efficacy concerns.)
First Posted : January 13, 2016
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
The current study is the first clinical trial proposed with PF-06815345. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of single oral doses of PF-06815345 to healthy adult subjects.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: PF-06815345 Other: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 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 Safety, Tolerability, And Pharmacokinetics Of Single Escalating Oral Doses Of Pf-06815345, As Well As Characterize The Pharmacokinetics Of Two Formulations And Effect Of Food On Pharmacokinetics Of One Formulation Of Pf-06815345 Administered To Healthy Adult Subjects
Actual Study Start Date : November 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Arm Intervention/treatment
Experimental: Part 1_Cohort 1_Active;
Single ascending dose of PF-06815345
Drug: PF-06815345
PF-06815345 will be administered as a liquid dosage formulation

Placebo Comparator: Part 1_Cohort 1_Placebo;
Single dose of placebo
Other: Placebo
Placebo

Experimental: Part 1_Cohort 2_Active
Single ascending dose of PF-06815345
Drug: PF-06815345
PF-06815345 will be administered as a liquid dosage formulation

Placebo Comparator: Part 1_Cohort 2_Placebo
Single dose of placebo
Other: Placebo
Placebo

Experimental: Part 2
Single dose of solid dosage formulation (test) versus liquid dosage formulation (reference) of PF-06815345
Drug: PF-06815345
PF-06815345 will be administered as either solid dosage formulation or liquid dosage formulation




Primary Outcome Measures :
  1. Number of Subjects With Treatment Emergent Treatment-Related Adverse Events (AEs) [ Time Frame: Baseline (Day 0) up to 28 days after last dose of study medication ]
    Treatment-related AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Drug was assessed by the investigator (Yes/No). Subjects with multiple occurrences of an AE within a category were counted once within the category.


Secondary Outcome Measures :
  1. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06815345 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 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- infinity)] for PF-06815345 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose ]
    AUC (0-infinity)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-infinity). It is obtained from AUC (0-t) plus AUC (t-infinity).

  3. Maximum Observed Plasma Concentration (Cmax) for PF-06815345 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose ]
    Maximum Observed Plasma Concentration (Cmax)

  4. Time to Reach Maximum Observed Concentration for PF-06815345 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose ]
    Time to Reach Maximum Observed Plasma Concentration (Tmax)

  5. Plasma Decay Half-Life (t1/2) for PF-06815345 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose ]
    Plasma Decay Half-Life (t1/2)

  6. Apparent Oral Clearance (CL/F) for PF-06815345 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 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. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

  7. Apparent Volume of Distribution (Vz/F) for PF-06815345 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 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.

  8. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for the metabolite (PF-06811701) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

  9. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for metabolite (PF-06811701) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose ]
    AUC (0-infinity)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-infinity). It is obtained from AUC (0-t) plus AUC (t-infinity).

  10. Maximum Observed Plasma Concentration (Cmax) for metabolite (PF-06811701) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose ]
    Maximum Observed Plasma Concentration (Cmax)

  11. Time to Reach Maximum Observed Concentration for metabolite (PF-06811701) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose ]
    Time to Reach Maximum Observed Plasma Concentration (Tmax)

  12. Plasma Decay Half-Life (t1/2) for metabolite (PF-06811701) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose ]
    Plasma Decay Half-Life (t1/2)



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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 males and female of non-childbearing potential;
  • Age of 18-55, inclusive;
  • Body Mass Index 17.5-34.9 kg/m2, inclusive;
  • Body weight >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)


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): NCT02654899


Locations
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Belgium
Pfizer Clinical Research Unit
Brussels, Belgium, 1070
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: NCT02654899    
Other Study ID Numbers: C0281001
2015-003935-36 ( EudraCT Number )
First Posted: January 13, 2016    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018
Keywords provided by Pfizer:
Healthy subjects
Single Ascending Dose
Hyperlipidemia
Dyslipidemia
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases