Study Evaluating The Safety and Tolerability of HTC-867 in Healthy Japanese Subjects
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01268124 |
Recruitment Status
:
Completed
First Posted
: December 29, 2010
Last Update Posted
: December 29, 2010
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Tracking Information | ||||
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First Submitted Date ICMJE | January 28, 2010 | |||
First Posted Date ICMJE | December 29, 2010 | |||
Last Update Posted Date | December 29, 2010 | |||
Study Start Date ICMJE | December 2008 | |||
Actual Primary Completion Date | April 2009 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Safety will be measured by vitals signs, labs and electrocardiograms (ECG's). [ Time Frame: 7 months ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | No Changes Posted | |||
Current Secondary Outcome Measures ICMJE |
Pharmacokinetics. [ Time Frame: 7 months ] | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Study Evaluating The Safety and Tolerability of HTC-867 in Healthy Japanese Subjects | |||
Official Title ICMJE | Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HTC-867 Administered Orally to Healthy Japanese Male Subjects | |||
Brief Summary | This is a phase 1, randomized (a process that is used to decide whether you will take study drug or a placebo during the study), inpatient study which will assess the safety and tolerability of HTC-867 in healthy male Japanese subjects. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Schizophrenia | |||
Intervention ICMJE | Drug: HTC-867 | |||
Study Arms | Experimental: Treatment
Intervention: Drug: HTC-867 |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
56 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | April 2009 | |||
Actual Primary Completion Date | April 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion:
Exclusion Criteria: Medical History
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Sex/Gender |
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Ages | 20 Years to 45 Years (Adult) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01268124 | |||
Other Study ID Numbers ICMJE | 3253A1-1001-JA | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth | |||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | February 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |