Study Evaluating Single Doses of GAP-134

Healthy Subjects Clinical Trial

Official title:

Ascending Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of GAP-134 Administered Orally to Healthy Subjects

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00820521
• Other study ID #: 3205A2-1003
• Status: Withdrawn
• Phase: Phase 1
• Start date: February 2009
• Est. completion date: April 2009

Study information

• Verified date: September 2018
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• active

• placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	pharmacokinetic parameters		2 months