Study Evaluating the Safety and Tolerability of SCA-136 in Healthy Japanese Male Subjects

This study has been completed.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer Identifier:
First received: July 24, 2007
Last updated: December 3, 2007
Last verified: December 2007
This study is being conducted to assess the safety and tolerability of ascending multiple oral doses of SCA-136 administered to healthy Japanese male subjects.

Condition Intervention Phase
Drug: SCA-136
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: An Ascending Multiple Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of SCA-136 Administered Orally to Healthy Japanese Male Subjects

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Adverse events, safety laboratory results, vital signs, and ECGs will be used to monitor subject safety.

Estimated Enrollment: 24
Study Start Date: July 2007
Study Completion Date: October 2007

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion criteria:

  • Healty Japanese men willing to use a medically acceptable form of contraception.

Exclusion criteria:

  • Any significant disease
  • Positive urine drug screen
  • Increased liver function tests
  • Use of prescription drugs.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00505973

Ikebukuro, Toshima-ku, Japan, 171-0014
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information Identifier: NCT00505973     History of Changes
Other Study ID Numbers: 3153A1-1114 
Study First Received: July 24, 2007
Last Updated: December 3, 2007
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency processed this record on May 02, 2016