ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Men or women of nonchildbearing potential (WONCBP) aged 18 to 50 years inclusive at screening.
- WONCBP may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for ≥1 year (with follicle stimulating hormone [FSH] level ≥38 mIU/mL) and must have a negative pregnancy test result within 24 hours before administration of the study drug or placebo.
- Women who are surgically sterile must provide documentation of the procedure by an operative report or by an ultrasound scan report.
- Sexually active men must agree to use a medically acceptable form of contraception during the study and continue using it for 12 weeks after study drug or placebo administration.
- Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight ≥50 kg.
- 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).
- Serum creatinine level must be less than 1.30 mg/dL. (Normal range: 0.44 to 1.24 mg/dL.)
- 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.
- Presence or history of any disorder that may prevent the successful completion of the
study.
- 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 study drug or placebo.
- Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before
administration of study drug or placebo.
- Any history of clinically important cardiac arrhythmias.
- Familial history of long QT syndrome or unexpected cardiac death.
- History of drug abuse within 1 year before before administration of study drug or
placebo.
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Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Study Evaluating Single Doses of GAP-134 | |||
Official Title ICMJE | Ascending Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of GAP-134 Administered Orally to Healthy Subjects | |||
Brief Summary | The purpose of this study is to assess the safety and tolerability of ascending single oral doses of GAP-134 in healthy subjects, to provide the initial pharmacokinetic profile of the oral formulation of GAP-134 in healthy subjects, and to evaluate the effect on the pharmacokinetic profile of a high-fat meal of 450 mg of GAP-134 administered to healthy subjects. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Healthy Subjects | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Withdrawn | |||
Actual Enrollment ICMJE | 0 | |||
Original Estimated Enrollment ICMJE | 24 | |||
Estimated Study Completion Date ICMJE | April 2009 | |||
Estimated Primary Completion Date | April 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 50 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00820521 | |||
Other Study ID Numbers ICMJE | 3205A2-1003 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | September 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |