Study Evaluating Single Doses of GAP-134

NCT00820521 | Withdrawn Phase 1

• 1 other identifier: 3205A2-1003
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• pharmacokinetic parameters

  2 months

Study Arms (2)

active

EXPERIMENTAL

Drug: active

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

active DRUG

active

placebo DRUG

placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2009
• First Posted: January 12, 2009
• Study Start: February 1, 2009
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: September 27, 2018

Record last verified: 2018-09