Study Evaluating The Safety and Tolerability of HTC-867 in Healthy Japanese Subjects

NCT01268124

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Schizophrenia
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-45 years
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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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Advanced Information
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  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
 (submitted: December 28, 2010)
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:

  1. Men aged 20 to 45 years inclusive at screening. Sexually active men must agree to use a medically acceptable form of contraception during the study and continue it for 12 weeks after test article administration.
  2. Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight ?45 kg.

    BMI is calculated by taking the subject's weight, in kilograms, divided by the square of the subject's height, in meters, at screening: BMI = Weight (kg)/[Height (m)]2.

  3. Healthy as determined by the investigator on the basis of screening evaluations.
  4. Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.
  5. Have a high probability for compliance with and completion of the study.

Exclusion Criteria:

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
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
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
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