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

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ClinicalTrials.gov Identifier: NCT00510029
Recruitment Status : Completed
First Posted : August 1, 2007
Last Update Posted : March 13, 2008
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

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.

Condition or disease Intervention/treatment Phase
Arrhythmia Drug: GAP-134 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of GAP-134 Administered Intravenously as a 24-Hour Infusion to Healthy Subjects.
Study Start Date : September 2007
Primary Completion Date : January 2008
Study Completion Date : January 2008

Arm Intervention/treatment
GAP-134, IV and Oral
Experimental; Active Comparator; Placebo
Drug: GAP-134
atrial fibrillation 24-hr IV infusion; 1-minute IV bolus; PO



Primary Outcome Measures :
  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 [ Time Frame: 3-4 months ]

Secondary Outcome Measures :
  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 [ Time Frame: 3-4 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00510029


Locations
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19148
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00510029     History of Changes
Other Study ID Numbers: 3205K2-1000
First Posted: August 1, 2007    Key Record Dates
Last Update Posted: March 13, 2008
Last Verified: March 2008