Single Ascending Dose of GAP-134 as a 24-hour IV Infusion in Healthy Japanese Males

NCT00543946 | Completed Phase 1

• 1 other identifier: 3205K2-1002
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study of GAP-134, an antiarrhythmic di-peptide. This study will provide an initial assessment of the safety, tolerability, and pharmacokinetics (PK) of GAP-134 after administration of ascending single intravenous (IV) doses to healthy Japanese male subjects.

Conditions

Arrhythmia

Outcome Measures

Primary Outcomes (1)

• The primary objective is to assess the safety and tolerability of ascending, single IV doses of GAP-134 as 24-hour continuous infusions and as a single bolus injection in healthy Japanese male subjects.

  6 months

Secondary Outcomes (1)

• The secondary objective is to provide the initial PK profiles of ascending single IV doses (24 hour and 1-minute) of GAP-134 taken under fasting conditions in healthy Japanese male subjects.

  6 months

Interventions

GAP-134 DRUG

24-Hour IV infusion, SAD

Eligibility Criteria

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

You may qualify if:

• Healthy Japanese men age 20-45.
• BMI within 17.6 to 26.4 kg/m2 and body weight greater than or equal to 45 kg.
• Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking within 48 hours before study day 1 until the end of the inpatient confinement period.

You may not qualify if:

• Any significant cardiovascular, 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 (e.g., resection of liver, kidney, gallbladder, or gastrointestinal tract).
• Acute disease state.
• Any history of clinically important cardiac arrhythmias. Family history of long QT syndrome, Torsades de Pointes or unexpected cardiac death.
• Any clinically important deviation from normal limits in physical examination, vital signs, 12-lead electrocardiograms (ECGs), or clinical laboratory test results. Creatinine levels must be less than or equal to the upper limit of normal at screening.
• Demonstration of a positive orthostatic test at screening. The definition of a positive test is a greater than or equal to 20 mm Hg decrease in systolic blood pressure, greater than or equal to 10 mm Hg decrease in diastolic blood pressure, or a greater than or equal to 30 bpm increase in pulse rate, after standing for 3 minutes.
• Positive serologic findings for human immunodeficiency virus (HIV) antigen and antibodies, hepatitis B surface antigen (HbsAg), and/or hepatitis C virus (HCV) antibodies.
• Positive findings of urine drug screen.
• History of any clinically important drug allergy or adverse drug reaction (e.g., relapsing dermatitis, drug hypersensitivity, drug allergy, hypersensitivity to ingredient in the test articles or angioedemas)
• Use of any investigational drug within 90 days before study day 1 or prescription drug within 30 days before study day 1.
• Consumption of any caffeine-containing products.
• 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 less than or equal to 100% of the recommended daily allowance), within 14 days before study day 1.

Sponsors & Collaborators

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

Study Sites (1)

Unknown Facility

Shinagawa-Ku, Tokyo, 141-0001, Japan

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

1-(2-aminoacetyl)-4-benzamidopyrrolidine-2-carboxylic acid

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2007
• First Posted: October 15, 2007
• Study Start: October 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: September 27, 2018

Record last verified: 2018-09

Locations

JP (1)