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

NCT01268124 | Completed Phase 1

• 1 other identifier: 3253A1-1001-JA
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Schizophrenia

Keywords

Japanese

Outcome Measures

Primary Outcomes (1)

• Safety will be measured by vitals signs, labs and electrocardiograms (ECG's).

  7 months

Secondary Outcomes (1)

• Pharmacokinetics.

  7 months

Study Arms (1)

Treatment

EXPERIMENTAL

Drug: HTC-867

Interventions

HTC-867 DRUG

Treatment

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.
• Healthy as determined by the investigator on the basis of screening evaluations.
• 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.
• Have a high probability for compliance with and completion of the study.

You may not qualify if:

• Medical History
• Presence or history of any disorder that may prevent the successful completion of the study.
• Any unstable medical condition.
• History of seizures.
• History of cardiac disorders (other than hypertension) including but not limited to valvular disease, congestive heart failure, angina pectoris, myocardial infarction, or arrhythmia.
• Any significant cardiovascular disease, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
• 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).
• Acute disease state (eg, nausea, vomiting, infection, fever, or diarrhea) within 7 days before study day 1).
• History of drug abuse within 1 year before study day 1.
• 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
• Clinically significant electrocardiogram (ECG) abnormalities.
• Any clinically important deviation from normal limits in physical examination findings, vital sign measurements, 12-lead ECGs, or clinical laboratory test results.
• Positive serologic findings for human immunodeficiency virus (HIV) antigen and antibodies, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibodies.
• Positive findings of urine drug screen (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates, and phencyclidine \[PCP\]).

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 28, 2010
• First Posted: December 29, 2010
• Study Start: December 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: December 29, 2010

Record last verified: 2010-02