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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00510029
First received: July 31, 2007
Last updated: March 12, 2008
Last verified: March 2008

July 31, 2007
March 12, 2008
September 2007
January 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
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
Complete list of historical versions of study NCT00510029 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
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
Not Provided
Not Provided
 
Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of GAP-134 Administered Intravenously
Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of GAP-134 Administered Intravenously as a 24-Hour Infusion to Healthy Subjects.

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Arrhythmia
Drug: GAP-134
atrial fibrillation 24-hr IV infusion; 1-minute IV bolus; PO
GAP-134, IV and Oral
Experimental; Active Comparator; Placebo
Intervention: Drug: GAP-134
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
January 2008
January 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00510029
3205K2-1000
No
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP