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

Phase 1

Completed

• Conditions: Schizophrenia
• Interventions: Drug: HTC-867

• Registration Number: NCT01268124
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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 available

Study Timeline

• Study Start: 2008-12
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Study First Submitted: 2010-01-28
• Status Verified: 2010-02
• Study First Submitted QC: 2010-12-28
• Last Update Submitted: 2010-12-28
• Study First Posted: 2010-12-29
• Last Update Posted: 2010-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 56

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	HTC-867	-

Primary Outcome Measures

Name	Time	Method
Safety will be measured by vitals signs, labs and electrocardiograms (ECG's).	7 months

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics.	7 months