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

NCT00510029 | Completed Phase 1

• 1 other identifier: 3205K2-1000
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The study will assess the safety, tolerability and pharmacokinetics of single intravenous (IV) doses of GAP-134 in healthy subjects. GAP-134 will be administered as a 24-hour infusion.

Conditions

Arrhythmia

Outcome Measures

Primary Outcomes (1)

• To assess the safety and tolerability of single ascending IV doses of GAP-134 administered as 24-hour continuous infusions and as single bolus injection of GAP-134 in healthy subjects

  3-4 months

Secondary Outcomes (1)

• To provide the initial Pharmacokinetic (PK) profile of single ascending IV doses (24 hour and 1-minute) and the initial PK assessment of the bioavailability of an oral formulation of GAP-134 under fasting conditions in healthy subjects

  3-4 months

Study Arms (1)

GAP-134, IV and Oral

OTHER

Experimental; Active Comparator; Placebo

Drug: GAP-134

Interventions

GAP-134 DRUG

atrial fibrillation 24-hr IV infusion; 1-minute IV bolus; PO

GAP-134, IV and Oral

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Generally healthy men and women of nonchildbearing potential (WONCBP), aged 18 to 50 years.
• Body Mass Index (BMI) range of 18 to 30 kg/m2.
• Blood serum creatinine levels less than or equal to the upper limit of normal.

You may not qualify if:

• Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
• Any history of clinically important cardiac arrhythmias and familial history of long QT syndrome or unexpected cardiac death.
• History of drug and alcohol abuse, positive HIV, HCV, and/or HBs Ag test, and any clinically important deviation from normal limits in physical examination, vital signs, 12-lead ECGs, or clinical laboratory test results.

Sponsors & Collaborators

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

Study Sites (1)

Unknown Facility

Philadelphia, Pennsylvania, 19148, United States

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 31, 2007
• First Posted: August 1, 2007
• Study Start: September 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: March 13, 2008

Record last verified: 2008-03

Locations

US (1)