Back to resultsSingle Dose Study of PF-06815345 in Healthy Subjects
Primary Purpose
Hypercholesterolemia
Status
Terminated
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
PF-06815345
Placebo
PF-06815345
Sponsored by
About this trial
This is an interventional basic science trial for Hypercholesterolemia focused on measuring Healthy subjects, Single Ascending Dose, Hyperlipidemia, Dyslipidemia
Eligibility 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)
Sites / Locations
- Pfizer Clinical Research Unit
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Arm Label
Part 1_Cohort 1_Active;
Part 1_Cohort 1_Placebo;
Part 1_Cohort 2_Active
Part 1_Cohort 2_Placebo
Part 2
Arm Description
Single ascending dose of PF-06815345
Single dose of placebo
Single ascending dose of PF-06815345
Single dose of placebo
Single dose of solid dosage formulation (test) versus liquid dosage formulation (reference) of PF-06815345
Outcomes
Primary Outcome Measures
Number of Subjects With Treatment Emergent Treatment-Related Adverse Events (AEs)
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
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06815345
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for PF-06815345
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).
Maximum Observed Plasma Concentration (Cmax) for PF-06815345
Maximum Observed Plasma Concentration (Cmax)
Time to Reach Maximum Observed Concentration for PF-06815345
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Plasma Decay Half-Life (t1/2) for PF-06815345
Plasma Decay Half-Life (t1/2)
Apparent Oral Clearance (CL/F) for PF-06815345
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.
Apparent Volume of Distribution (Vz/F) for PF-06815345
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.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for the metabolite (PF-06811701)
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for metabolite (PF-06811701)
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).
Maximum Observed Plasma Concentration (Cmax) for metabolite (PF-06811701)
Maximum Observed Plasma Concentration (Cmax)
Time to Reach Maximum Observed Concentration for metabolite (PF-06811701)
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Plasma Decay Half-Life (t1/2) for metabolite (PF-06811701)
Plasma Decay Half-Life (t1/2)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02654899
Brief Title
Single Dose Study of PF-06815345 in Healthy Subjects
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Terminated
Why Stopped
Trial discontinued on 04Apr2016 as a strategic business decision not to pursue the indication. Decision to terminate not due to safety or efficacy concerns.
Study Start Date
November 2015 (Actual)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
Healthy subjects, Single Ascending Dose, Hyperlipidemia, Dyslipidemia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part 1_Cohort 1_Active;
Arm Type
Experimental
Arm Description
Single ascending dose of PF-06815345
Arm Title
Part 1_Cohort 1_Placebo;
Arm Type
Placebo Comparator
Arm Description
Single dose of placebo
Arm Title
Part 1_Cohort 2_Active
Arm Type
Experimental
Arm Description
Single ascending dose of PF-06815345
Arm Title
Part 1_Cohort 2_Placebo
Arm Type
Placebo Comparator
Arm Description
Single dose of placebo
Arm Title
Part 2
Arm Type
Experimental
Arm Description
Single dose of solid dosage formulation (test) versus liquid dosage formulation (reference) of PF-06815345
Intervention Type
Drug
Intervention Name(s)
PF-06815345
Intervention Description
PF-06815345 will be administered as a liquid dosage formulation
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
PF-06815345
Intervention Description
PF-06815345 will be administered as either solid dosage formulation or liquid dosage formulation
Primary Outcome Measure Information:
Title
Number of Subjects With Treatment Emergent Treatment-Related Adverse Events (AEs)
Description
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.
Time Frame
Baseline (Day 0) up to 28 days after last dose of study medication
Secondary Outcome Measure Information:
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06815345
Description
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Time Frame
0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Title
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for PF-06815345
Description
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).
Time Frame
0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Title
Maximum Observed Plasma Concentration (Cmax) for PF-06815345
Description
Maximum Observed Plasma Concentration (Cmax)
Time Frame
0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Title
Time to Reach Maximum Observed Concentration for PF-06815345
Description
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame
0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Title
Plasma Decay Half-Life (t1/2) for PF-06815345
Description
Plasma Decay Half-Life (t1/2)
Time Frame
0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Title
Apparent Oral Clearance (CL/F) for PF-06815345
Description
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.
Time Frame
0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Title
Apparent Volume of Distribution (Vz/F) for PF-06815345
Description
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.
Time Frame
0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for the metabolite (PF-06811701)
Description
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Time Frame
0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Title
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for metabolite (PF-06811701)
Description
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).
Time Frame
0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Title
Maximum Observed Plasma Concentration (Cmax) for metabolite (PF-06811701)
Description
Maximum Observed Plasma Concentration (Cmax)
Time Frame
0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Title
Time to Reach Maximum Observed Concentration for metabolite (PF-06811701)
Description
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame
0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Title
Plasma Decay Half-Life (t1/2) for metabolite (PF-06811701)
Description
Plasma Decay Half-Life (t1/2)
Time Frame
0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
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 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)
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 Clinical Research Unit
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=C0281001&StudyName=A%20Phase%201%2C%20Randomized%2C%20Double-blind%2C%20Placebo-controlled%20Study%20To%20Assess%20Safety%2C%20Tolerability%2C%20And%20Pharmacokinetics%20Of%20Single%20Escalating%20Oral%20Doses%20Of%20Pf-06815345%2C%20As%20Well%20As%20Characterize%20The%20Pharmacokinetics%20Of%20Two%20Formulations%20And%20Effect%20Of%20Food%20On%20Pharmacokinetics%20Of%20One%20Formulation%20Of%20Pf%E2%80%9106815345%20Administered%20To%20Healthy%20Adult%20Subjects
Description
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Single Dose Study of PF-06815345 in Healthy Subjects
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