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Study Evaluating Single Doses of GAP-134

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Subjects
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-50 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00820521
Pfizer
Withdrawn
Study Evaluating Single Doses of GAP-134

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Study Evaluating Single Doses of GAP-134
Ascending Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of GAP-134 Administered Orally to Healthy Subjects
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Healthy Subjects
  • Drug: active
  • Drug: placebo
  • Experimental: active
    Intervention: Drug: active
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
24
April 2009
April 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00820521
3205A2-1003
No
Not Provided
Not Provided
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
January 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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