Study Evaluating The Safety and Tolerability of HTC-867 in Healthy Japanese Subjects
NCT01268124
ABOUT THIS STUDY
FOR MORE INFORMATION
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Medical History
1. Presence or history of any disorder that may prevent the successful completion of the
study.
2. Any unstable medical condition.
3. History of seizures.
4. History of cardiac disorders (other than hypertension) including but not limited to
valvular disease, congestive heart failure, angina pectoris, myocardial infarction, or
arrhythmia.
5. Any significant cardiovascular disease, hepatic, renal, respiratory, gastrointestinal,
endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
6. Any surgical or medical condition that may interfere with the absorption,
distribution, metabolism, or excretion of the test article (eg, resection of liver,
kidney, gallbladder, or gastrointestinal tract).
7. Acute disease state (eg, nausea, vomiting, infection, fever, or diarrhea) within 7
days before study day 1).
8. History of drug abuse within 1 year before study day 1.
9. Admitted alcohol abuse or history of alcohol use that may interfere with the subject's
ability to comply with the protocol requirements.
Physical and Laboratory Findings
10. Clinically significant electrocardiogram (ECG) abnormalities.
11. Any clinically important deviation from normal limits in physical examination
findings, vital sign measurements, 12-lead ECGs, or clinical laboratory test results.
12. Positive serologic findings for human immunodeficiency virus (HIV) antigen and
antibodies, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV)
antibodies.
13. Positive findings of urine drug screen (eg, amphetamines, barbiturates,
benzodiazepines, cannabinoids, cocaine, opiates, and phencyclidine [PCP]).
14. Troponin T or CK-MB levels above reference range at screening. Allergies and Adverse
Drug Reactions
15. History of any clinically important drug allergy (eg, relapsing dermatitis, drug
hypersensitivity, drug allergy, hypersensitivity to ingredient in the test articles,
angioedema).
Prohibited Treatments
16. Use of any investigational drug within 90 days before study day 1 or prescription drug
within 30 days before study day 1.
17. Tobacco use or the consumption of any caffeine-containing products (eg, coffee, tea,
chocolate, or carbonated beverages) or alcoholic beverages within 72 hours before
study day 1 until the end of the inpatient confinement period.
18. Consumption of grapefruit or grapefruit-containing products within 72 hours before
study day 1 until the end of the inpatient confinement period.
19. Use of any over-the-counter drugs, including herbal supplements (except for the
occasional use of vitamins ≤100% of the recommended daily allowance), within 14 days
before study day 1 (St. John wort is prohibited within 30 days of study day 1).
20. Donation of blood within 90 days before study day 1. Others
21. Subjects deemed by the investigator to be inappropriate according to the inclusion
criteria in the study and according to the screening examination.
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Descriptive Information | ||||
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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 ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE | Schizophrenia | |||
Intervention ICMJE | Drug: HTC-867 | |||
Study Arms ICMJE | Experimental: Treatment
Intervention: Drug: HTC-867 | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 56 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | April 2009 | |||
Actual Primary Completion Date | April 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion:
Exclusion Criteria: Medical History
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 20 Years to 45 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | 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 ICMJE | 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 |
| |||
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 |