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First-In-Human Study Of Single And Multiple Ascending Doses Of PF-06751979

Last updated on November 3, 2018

FOR MORE INFORMATION
Study Location
California Clinical Trials Medical Group, Inc
Glendale, California, 91206 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Subjects
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-85 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male and/or female subjects of non-childbearing potential between the ages of
18 and 55 years or between the ages of 60 and 85 years, inclusive.

- Body Mass Index (BMI) of 17.5 to 32 kg/m2; and a total body weight >50 kg (110 lbs) at
Screening.

- Evidence of a personally signed and dated informed consent document indicating that
the subject or a legally acceptable representative has been informed of all pertinent
aspects of the study.

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

- 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 the time of dosing).

- Male subjects with partners currently pregnant; male subjects able to father children
who are unwilling or unable to use a highly effective method of contraception as
outlined in this protocol for the duration of the study and for at least 28 days after
the last dose of investigational product.

- Unwilling or unable to comply with the Lifestyle Guidelines described in this
protocol.

- Subjects who are investigational site staff members directly involved in the conduct
of the study and their family members, site staff members otherwise supervised by the
Investigator, or subjects who are Pfizer employees directly involved in the conduct of
the study.

- Any severe acute or chronic medical or psychiatric condition including recent (within
the past year) or active suicidal ideation or behavior or laboratory abnormality that
may increase the risk associated with study participation or investigational product
administration or may interfere with the interpretation of study results and, in the
judgment of the Investigator, would make the subject inappropriate for entry into this
study.

NCT02509117
Pfizer
Completed
First-In-Human Study Of Single And Multiple Ascending Doses Of PF-06751979

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Similar Trials

First-In-Human Study Of Single And Multiple Ascending Doses Of PF-06751979
A Phase 1, Randomized, Double-blind, Sponsor-open, Placebo Controlled First-in-human Trial To Evaluate The Safety,Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06751979 After Oral Administration Of Single And Multiple Ascending Doses To Healthy Adult And Elderly Subjects
The purpose of this study is to evaluate the safety, tolerability, PK and PD of PF-06751979 following oral doses in healthy adult and healthy elderly subjects.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Healthy Subjects
  • Drug: PF-06751979 single ascending dose
    PF-06751979 administered as a single dose (solution/suspension) in cross-over fashion. Each subject may receive up to 4 study treatments (placebo and up to 3 doses of PF-06751979). The dose levels are 3 mg, 12 mg, 40 mg, 160 mg.
  • Drug: Placebo single dose
    Matched Placebo solution/suspension administered as single dose.
  • Drug: PF-06751979 multiple ascending dose
    PF-06751979 (solution/suspension) administered daily for 14 consecutive days to parallel cohorts. The dose levels are 5 mg, 15 mg, 50 mg.
  • Drug: Placebo multiple dose
    Matched Placebo (solution/suspension)administered daily for 14 consecutive days.
  • Drug: PF-06751979 multiple dose
    PF-06751979 (solution/suspension) administered daily for 14 consecutive days. The dose level is 50 mg.
  • Drug: PF-06751979 multiple dose
    Matched Placebo (suspension/solution) administered daily for 14 consecutive days to parallel cohorts.
  • Experimental: Single Ascending Dose Cross-over
    Single Ascending Dose in 4-way cross-over design (PF-06751979/Placebo).
    Interventions:
    • Drug: PF-06751979 single ascending dose
    • Drug: Placebo single dose
  • Experimental: Multiple Ascending Dose PF-06751979
    Multiple dose administration to Healthy Subjects in parallel cohorts(PF-06751979)
    Intervention: Drug: PF-06751979 multiple ascending dose
  • Placebo Comparator: Multiple Ascending Dose Placebo
    Multiple dose administration to Healthy Subjects in parallel cohorts(Placebo)
    Interventions:
    • Drug: Placebo multiple dose
    • Drug: PF-06751979 multiple dose
  • Experimental: Multiple Dose Elderly PF-06751979
    Multiple dose administration to Healthy Elderly Subjects (PF-06751979)
    Intervention: Drug: PF-06751979 multiple dose
  • Placebo Comparator: Multiple Dose Elderly Placebo
    Multiple dose administration to Healthy Elderly Subjects (Placebo)
    Intervention: Drug: Placebo multiple dose
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
July 2016
July 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years or between the ages of 60 and 85 years, inclusive.
  • Body Mass Index (BMI) of 17.5 to 32 kg/m2; and a total body weight >50 kg (110 lbs) at Screening.
  • Evidence of a personally signed and dated informed consent document indicating that the subject or a legally acceptable representative has been informed of all pertinent aspects of the study.

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 the time of dosing).
  • Male subjects with partners currently pregnant; male subjects able to father children who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
  • Unwilling or unable to comply with the Lifestyle Guidelines described in this protocol.
  • Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the Investigator, or subjects who are Pfizer employees directly involved in the conduct of the study.
  • Any severe acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02509117
B8271001
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 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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