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First In Human Study Of Increasing Oral Doses Of PF-04634817

Last updated on December 17, 2017

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Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
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 male or female (of non-child bearing potential) subjects between 18 and 55
years of age.

- Body mass index of 17.5 to 30.5 kg/m2 and total body weight > 50kg.

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

- Evidence or history of any clinically significant disease.

- Treatment with an investigational drug within 30 days of study start

- Use of prescription and non-prescription medicines within 7 days of study start

NCT01098877
Pfizer
Completed
First In Human Study Of Increasing Oral Doses Of PF-04634817

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First In Human Study Of Increasing Oral Doses Of PF-04634817
A Double Blind, Randomized, Placebo Controlled, Dose Escalation Study To Investigate The Pharmacokinetics (In The Fed And Fasted State), Safety And Toleration Of Single Oral Doses Of PF-04634817 In Healthy Volunteers
The study will evaluate the hypothesis that at doses and plasma concentrations which affect pharmacodynamic markers of activity at the chemokine receptors, CCR2 and CCR5, the compound is safe and well tolerated. It will also evaluate the hypothesis that the pharmacokinetic profile is robust and consistent with a once or twice a day therapeutic administration.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Healthy
  • Drug: PF-04634817 Placebo
    Oral solution, placebo, single dose
  • Drug: PF-04634817
    Oral solution, 1mg, single dose
  • Drug: PF-04634817
    Oral solution, 3mg, single dose
  • Drug: PF-04634817
    Oral solution, 10mg, single dose
  • Drug: PF-04634817
    Oral solution, 30mg, single dose
  • Drug: PF-04634817
    Oral solution, 100mg, single dose
  • Drug: PF-04634817
    Oral solution, 300mg, single dose
  • Drug: PF-04634817
    Oral solution, 600mg, single dose
  • Drug: PF-04634817
    Oral solution, 900mg, single dose
  • Drug: PF-04634817
    Oral solution, up to 900mg, single dose after food
  • Drug: PF-04634817 Placebo
    Oral solution, placebo, single dose after food
  • Placebo Comparator: Placebo
    Intervention: Drug: PF-04634817 Placebo
  • Experimental: Cohort 1, 1mg
    Intervention: Drug: PF-04634817
  • Experimental: Cohort 1, 3mg
    Intervention: Drug: PF-04634817
  • Experimental: Cohort 1, 10mg
    Intervention: Drug: PF-04634817
  • Experimental: Cohort 2, 30mg
    Intervention: Drug: PF-04634817
  • Experimental: Cohort 2, 100mg
    Intervention: Drug: PF-04634817
  • Experimental: Cohort 2, 300mg
    Intervention: Drug: PF-04634817
  • Experimental: Cohort 3, 600mg
    Intervention: Drug: PF-04634817
  • Experimental: Cohort 3, 900mg
    Intervention: Drug: PF-04634817
  • Experimental: Cohort 3, up to 900mg (fed)
    Intervention: Drug: PF-04634817
  • Placebo Comparator: Cohort 3, placebo (fed)
    Intervention: Drug: PF-04634817 Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
September 2010
September 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male or female (of non-child bearing potential) subjects between 18 and 55 years of age.
  • Body mass index of 17.5 to 30.5 kg/m2 and total body weight > 50kg.

Exclusion Criteria:

  • Evidence or history of any clinically significant disease.
  • Treatment with an investigational drug within 30 days of study start
  • Use of prescription and non-prescription medicines within 7 days of study start
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01098877
B1261002
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2010

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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