You are here

A Phase 1 Study To Investigate The Pharmacokinetics, Safety And Tolerability Of CP-601,927 In Healthy Japanese Subjects

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
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 and/or female Japanese subjects between the ages of 18 and 55 years,
inclusive.

- Japanese defined as being able to document that all 4 grandparents were Japanese and
were born in Japan.

- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

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).

- Females of childbearing potential.

- Subjects with regular (daily or weekly) use of tobacco products or nicotine currently
or within the past 6 months. Subjects with urine cotinine concentrations >100 ng/mL at
any time during the study will be excluded.

NCT01396135
Pfizer
Withdrawn
A Phase 1 Study To Investigate The Pharmacokinetics, Safety And Tolerability Of CP-601,927 In Healthy Japanese Subjects

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Healthy Volunteers
NCT03184168
Males
18+
Years
Madison, Wisconsin
Healthy
NCT03711708
All Genders
18+
Years
Aparecida de Goiania, GO
A Phase 1 Study To Investigate The Pharmacokinetics, Safety And Tolerability Of CP-601,927 In Healthy Japanese Subjects
A Phase 1, Randomized, Subject- And Investigator-Blind, Sponsor-Open, Placebo-Controlled, Single- And Multiple-Dose Study To Investigate The Pharmacokinetics, Safety And Tolerability Of CP-601,927 In Healthy Japanese Subjects
This Phase 1 study is the first clinical trial to be conducted in Japanese subjects. The pharmacokinetics, safety and tolerability of single and multiple doses of CP-601,927 will be evaluated in Japanese, healthy, non-smoking subjects.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Healthy
  • Drug: CP-601,927
    Single dose of 1 mg CP-601,927 given as oral 1 mg tablets
  • Drug: CP-601,927
    Single dose of 2 mg CP-601,927 given as oral 1 mg tablets
  • Drug: CP-601,927
    Single dose of 3 mg CP-601,927 given as oral 1 mg tablets
  • Drug: Placebo
    Single dose of placebo given as a matching number of oral tablets
  • Drug: CP-601,927
    Multiple doses of CP-601,927 given as 2 mg BID (4 mg/day) as oral 1 mg tablets for 7 days
  • Drug: Placebo
    Multiple doses of placebo given as a matching number of oral tablets
  • Experimental: Single dosing
    Single doses of CP-601,927 (1, 2 or 3 mg) or placebo
    Interventions:
    • Drug: CP-601,927
    • Drug: CP-601,927
    • Drug: CP-601,927
    • Drug: Placebo
  • Experimental: Multiple dosing
    Multiple doses of CP-601,927 (2 mg BID, 4mg/day) or placebo
    Interventions:
    • Drug: CP-601,927
    • Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
19
October 2011
October 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male and/or female Japanese subjects between the ages of 18 and 55 years, inclusive.
  • Japanese defined as being able to document that all 4 grandparents were Japanese and were born in Japan.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

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).
  • Females of childbearing potential.
  • Subjects with regular (daily or weekly) use of tobacco products or nicotine currently or within the past 6 months. Subjects with urine cotinine concentrations >100 ng/mL at any time during the study will be excluded.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01396135
A3331019
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2011

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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now