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Study Evaluating Drug Interaction Between Multiple Doses of Ketoconazole and a Single Dose of SKI-606

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00434486
First received: February 9, 2007
Last updated: September 10, 2007
Last verified: September 2007
History of Changes
  Purpose

To investigate a potential pharmacokinetic interaction between SKI-606 and ketoconazole when co-administered.


Condition Intervention Phase
Healthy
 Drug: SKI-606
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Randomized, 2-Period Crossover Study to Evaluate the Potential Pharmacokinetic Interaction Between Multiple Doses of Ketoconazole and a Single Dose of SKI-606 Administered Orally to Healthy Subjects

Resource links provided by NLM:

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

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

Primary Outcome Measures:
  • Pharmacokinetics; safety and tolerability

Estimated Enrollment: 24
Study Start Date: March 2007
Estimated Study Completion Date: March 2007
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead ECG.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00434486

Locations
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19148
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00434486     History of Changes
Other Study ID Numbers: 3160A4-104
Study First Received: February 9, 2007
Last Updated: September 10, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ketoconazole
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013