Healthy Subjects
Conditions
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.
Interventions
DRUGactive
DRUGplacebo
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability will be evaluated from reported AEs, scheduled physical examinations, vital sign measurements, cardiac rhythm monitoring, 12 lead ECGs, and clinical laboratory test results. | 2 months |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetic parameters | 2 months |
Outcome results
None listed