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Single Dose Study of PF-06815345 in Healthy Subjects

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Clinical Research Unit
Brussels, , 1070 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypercholesterolemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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)

NCT02654899
Pfizer
Unknown status
Single Dose Study of PF-06815345 in Healthy Subjects

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Single Dose Study of PF-06815345 in Healthy Subjects
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Hypercholesterolemia
  • Drug: PF-06815345
    PF-06815345 will be administered as a liquid dosage formulation
  • Other: Placebo
    Placebo
  • Drug: PF-06815345
    PF-06815345 will be administered as either solid dosage formulation or liquid dosage formulation
  • Experimental: Part 1_Cohort 1_Active;
    Single ascending dose of PF-06815345
    Intervention: Drug: PF-06815345
  • Placebo Comparator: Part 1_Cohort 1_Placebo;
    Single dose of placebo
    Intervention: Other: Placebo
  • Experimental: Part 1_Cohort 2_Active
    Single ascending dose of PF-06815345
    Intervention: Drug: PF-06815345
  • Placebo Comparator: Part 1_Cohort 2_Placebo
    Single dose of placebo
    Intervention: Other: Placebo
  • Experimental: Part 2
    Single dose of solid dosage formulation (test) versus liquid dosage formulation (reference) of PF-06815345
    Intervention: Drug: PF-06815345
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
25
July 2016
May 2016   (Final data collection date for primary outcome measure)

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)

Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT02654899
C0281001
2015-003935-36 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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