Study Evaluating Single Doses of GAP-134

NCT00820521

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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.

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Advanced Information
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
  • Drug: active
  • Drug: placebo
Study Arms  ICMJE
  • Experimental: active
    Intervention: Drug: active
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
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
 (submitted: September 25, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: January 9, 2009)
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

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
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