Study Evaluating The Safety and Tolerability of HTC-867 in Healthy Japanese Subjects
This study has been completed.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
First received: January 28, 2010
Last updated: December 28, 2010
Last verified: February 2010
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.
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HTC-867 Administered Orally to Healthy Japanese Male Subjects
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||April 2009 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||20 Years to 45 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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]).
- Troponin T or CK-MB levels above reference range at screening. Allergies and Adverse Drug Reactions
History of any clinically important drug allergy (eg, relapsing dermatitis, drug hypersensitivity, drug allergy, hypersensitivity to ingredient in the test articles, angioedema).
- Use of any investigational drug within 90 days before study day 1 or prescription drug within 30 days before study day 1.
- 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.
- Consumption of grapefruit or grapefruit-containing products within 72 hours before study day 1 until the end of the inpatient confinement period.
- 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).
- Donation of blood within 90 days before study day 1. Others
- 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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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
Wyeth is now a wholly owned subsidiary of Pfizer
||Wyeth is now a wholly owned subsidiary of Pfizer
No publications provided
||Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 28, 2010
||December 28, 2010
||Japan: Pharmaceuticals and Medical Devices Agency
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
ClinicalTrials.gov processed this record on March 03, 2015