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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT01268124
First received: January 28, 2010
Last updated: December 28, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: HTC-867
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HTC-867 Administered Orally to Healthy Japanese Male Subjects

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Safety will be measured by vitals signs, labs and electrocardiograms (ECG's). [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics. [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]

Enrollment: 56
Study Start Date: December 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Drug: HTC-867

  Eligibility

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

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.
  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 ClinicalTrials.gov identifier: NCT01268124

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

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT01268124     History of Changes
Other Study ID Numbers: 3253A1-1001-JA
Study First Received: January 28, 2010
Last Updated: December 28, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Japanese

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on October 21, 2014