Study of the Safety, Tolerability, and Pharmacokinetics of GAP-134 Administered Intravenously

An Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of GAP-134 Administered Intravenously as 6-Day Continuous Infusions to Healthy Subjects

This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of ascending doses of GAP 134 administered as 6-day continuous IV infusions to healthy subjects.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: placebo; Drug: GAP-134

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19428

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion

1. Men or women of non childbearing potential (WONCBP) aged 18 to 50 years inclusive at screening.
2. Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight ≥50 kg.
3. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital sign measurements, and 12-lead electrocardiogram (ECG).
4. Serum creatinine level must be less than 1.30 mg/dL. (Normal range: 0.44 to 1.24 mg/dL.)
5. 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.

Exclusion

1. Presence or history of any disorder that may prevent the successful completion of the study.
2. Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
3. Any surgical or medical condition that may interfere with the distribution, metabolism, or excretion of the test article.
4. Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before study day 1.
5. Any history of clinically important cardiac arrhythmias.
6. Familial history of long QT syndrome or unexpected cardiac death.
7. History of drug abuse within 1 year before study day 1.
8. History of alcoholism within 1 year before study day 1.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: placebo	Drug: placebo
EXPERIMENTAL: GAP-134	Drug: GAP-134

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety as determined by reported adverse events, laboratory test results, and ECGs	3 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetic parameters	9 days

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (ACTUAL): February 1, 2009
• Study Completion (ACTUAL): February 1, 2009

Study Registration Dates

• First Submitted: October 30, 2008
• First Submitted That Met QC Criteria: October 30, 2008
• First Posted (ESTIMATE): October 31, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): July 17, 2009
• Last Update Submitted That Met QC Criteria: July 16, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Other Study ID Numbers: 3205K2-1001