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A Multiple Oral Doses Study Of PF-06427878 In Healthy Adult Subjects

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ClinicalTrials.gov Identifier: NCT02391623
Recruitment Status : Completed
First Posted : March 18, 2015
Last Update Posted : March 2, 2016
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 multiple oral doses of PF-06427878 in healthy adult subjects.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
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 Multiple Escalating Oral Doses Of Pf-06427878 Co Administered With And Without Food In Healthy Adult Subjects
Study Start Date : March 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Arm Intervention/treatment
Experimental: Cohort 1
Single dose level of PF-06427878 at 5 mg or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
Drug: PF-06427878
PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).

Drug: Placebo
Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).

Experimental: Cohort 2
Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 1 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
Drug: PF-06427878
PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).

Drug: Placebo
Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).

Experimental: Cohort 3
Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 2 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
Drug: PF-06427878
PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).

Drug: Placebo
Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).

Experimental: Cohort 4
Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 3 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
Drug: PF-06427878
PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).

Drug: Placebo
Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).

Experimental: Cohort 5
Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 4 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
Drug: PF-06427878
PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).

Drug: Placebo
Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).

Experimental: Cohort 6
Single dose level of PF-06427878 (with the same total daily dose as Cohort 5) or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
Drug: PF-06427878
PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).

Drug: Placebo
Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).




Primary Outcome Measures :
  1. Assessment of adverse events (AEs). [ Time Frame: 0-25 days ]
  2. Assessment of clinical laboratory tests. [ Time Frame: 0-25 days ]
  3. Assessment of vital signs (including blood pressure and pulse rate). [ Time Frame: 0-25 days ]
  4. Assessment of cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG). [ Time Frame: 0-25 days ]

Secondary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1 [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose ]
  2. Maximum Observed Plasma Concentration (Cmax) for PF-06427878during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12 [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose ]
  3. Maximum Observed Plasma Concentration (Cmax) for PF-06427878 on day 14 [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12 hours post dose ]
  4. Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1 [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose ]
  5. Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12 [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose ]
  6. Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose ]
  7. Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1 [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose ]
  8. Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12 [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose ]
  9. Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose ]
  10. Plasma Decay Half-Life (t1/2) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose ]
  11. Apparent Volume of Distribution (Vz/F) of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose ]
  12. Apparent Oral Clearance (CL/F) of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose ]
  13. Minimum Observed Plasma Concentration (Cmin) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose ]
  14. Peak:Trough ratio of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose ]
  15. Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06427878 on day14 relative to day 1 [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12 hours post dose ]
  16. Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06427878 on day14 relative to day 1 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose ]
  17. Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUCtau)) for PF-06427878 on day14 relative to day 1 [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose ]
  18. Amount of PF-06427878 excreted in urine (Ae) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 [ Time Frame: 0- tau hours post dose ]
  19. Percent of dose excreted in urine as PF-06427878 (Ae%) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 [ Time Frame: 0- tau hours post dose ]
  20. Renal clearance of PF-06427878 (CLr) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14 [ Time Frame: 0- tau hours post dose ]


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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
  • Subjects with low density lipoprotein cholesterol between 115 mg/dL and 190 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): NCT02391623


Locations
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Belgium
Pfizer Clinical Research Unit
Brussels, Belgium, B-1070
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02391623    
Other Study ID Numbers: B7871002
2015-000130-29 ( EudraCT Number )
First Posted: March 18, 2015    Key Record Dates
Last Update Posted: March 2, 2016
Last Verified: March 2016
Keywords provided by Pfizer:
Multiple Ascending Dose
Healthy Subjects
Hyperlipidemia
Lipid Metabolism Disorders
Metabolic Diseases