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A Study of the Safety, Tolerability, and Pharmacokinetics of AGG-523 in Healthy Japanese Males

Last updated on December 15, 2017

FOR MORE INFORMATION
Study Location
Ikebukuro, Tokyo, 1520003 Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-40 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Men aged 20 to 40 years, inclusive, at screening; sexually active men must agree to
use a medically acceptable form of contraception during the study and continue for 12
weeks after test article administration.

- Body mass index (BMI) in the range of 17.6 to 26.4 Kgm2, and body weight >45 kg.

- Healthy as determined by the investigator on the basis of medical history, physical
examination, clinical laboratory test results, vital signs, and 12 lead ECG.

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

- Men aged 20 to 40 years, inclusive, at screening; sexually active men must agree to
use a medically acceptable form of contraception during the study and continue for 12
weeks after test article administration.

- Body mass index (BMI) in the range of 17.6 to 26.4 Kgm2, and body weight >45 kg.

- Healthy as determined by the investigator on the basis of medical history, physical
examination, clinical laboratory test results, vital signs, and 12 lead ECG.

NCT00434785
Pfizer
Completed
A Study of the Safety, Tolerability, and Pharmacokinetics of AGG-523 in Healthy Japanese Males

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A Study of the Safety, Tolerability, and Pharmacokinetics of AGG-523 in Healthy Japanese Males
An Ascending, Multiple Dose Study of the Safety, Tolerability, and Pharmacokinetics of AGG-523 Administered Orally to Healthy Male Japanese Subjects.
To assess the safety and tolerability of ascending, multiple oral doses of AGG-523 in healthy Japanese subjects.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Healthy
Drug: AGG-523
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
September 2007
Not Provided

Inclusion Criteria:

  • Men aged 20 to 40 years, inclusive, at screening; sexually active men must agree to use a medically acceptable form of contraception during the study and continue for 12 weeks after test article administration.
  • Body mass index (BMI) in the range of 17.6 to 26.4 Kgm2, and body weight >45 kg.
  • Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12 lead ECG.
Sexes Eligible for Study: Male
20 Years to 40 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00434785
3189A1-105
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
December 2007

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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