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Phase 1 N=10 Randomized

Study to Evaluate Potential Food Effects

Healthy

Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Sep 2011
Primary outcome: Primary: Cmax — 2567.9; 3568.9 ng/mL

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
PG-760564 (Drug)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Procter and Gamble
Primary completion
Jan 2006

Outcome Measures

OutcomeResultp-value
PRIMARY
Cmax
2567.9; 3568.9

Summary

Half the group will be given a high fat diet and the other half will fast. They will then be crossed over.

Eligibility Criteria

Inclusion Criteria

  • Healthy males and surgically sterile or post-menopausal (last menstrual period > 1 year at the time of enrollment) healthy females, 18-45 years of age, inclusive, at screening;
  • Who have not used tobacco or nicotine-containing products within the past 3 months;
  • Willing to abstain from caffeine or xanthine-containing beverages, including coffee and tea, chocolate, alcohol, grapefruit juice, and Seville oranges, from 24 hours before admission and for the duration of the study;
  • Who have a body mass index (BMI) between 18 and 32 kg/m2, inclusive.

Exclusion Criteria

  • History of diabetes, cardiovascular, hepatic, renal, or malabsorptive disease;
  • History of diabetes, cardiovascular, hepatic, renal, or malabsorptive disease;
  • History of peptic ulcer disease, hemorrhoids, GI surgery (appendectomy and cholecystectomy are allowed), or GI bleeding;
  • History of autoimmune disease;
  • History of immunodeficiency or of unusual susceptibility to infectious diseases;
  • History of tuberculosis, acquired immunodeficiency syndrome (AIDS), or infection with human immunodeficiency virus (HIV);
  • Any history of hypersensitivity or clinically significant allergy to any drug;
  • Personal or family history of prolonged QT syndrome or any cardiac conduction abnormality;
  • Family history of sudden death;
  • History of uveitis or inflammatory ocular disease;
  • History of peptic ulcer disease, hemorrhoids, GI surgery (appendectomy and cholecystectomy are allowed), or GI bleeding;
  • History of autoimmune disease;
  • History of immunodeficiency or of unusual susceptibility to infectious diseases;
  • History of tuberculosis, acquired immunodeficiency syndrome (AIDS), or infection with human immunodeficiency virus (HIV);
  • Any history of hypersensitivity or clinically significant allergy to any drug;
  • Personal or family history of prolonged QT syndrome or any cardiac conduction abnormality;
  • Family history of sudden death;
  • History of uveitis or inflammatory ocular disease.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00791817). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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