Phase 1
N=11
Multiple Rising Oral Dose Study of PG 760564 Administered Twice Daily to Healthy Male/Female Volunteers for 14 Days
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT00791388 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Nov 2011
Primary outcome: Primary: AUCτ Over a Dosing Interval (τ = 12 Hours) on Day 14 — 12090.998; 23472.1329; 30005.781; 50354.938 ng*h/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Placebo (Drug); PG-760564 (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Procter and Gamble
- Primary completion
- Jan 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AUCτ Over a Dosing Interval (τ = 12 Hours) on Day 14 |
12090.998; 23472.1329; 30005.781; 50354.938 | — |
| PRIMARY Cmax Over a Dosing Interval (τ = 12 Hours)on Day 14 |
1601.4; 2951.3; 3935.0; 7195.0 | — |
| PRIMARY Tmax Over a Dosing Interval (τ = 12 Hours) on Day 14 |
2.46; 2.89; 3.01; 2.03 | — |
| PRIMARY t½,z Over a Dosing Interval (τ = 12 Hours)on Day 14 |
9.411; 7.882; 10.223; 9.701 | — |
Summary
This study is a multiple ascending dose study to Assess the Safety, Tolerability, and Pharmacokinetics of orally dosed PG 760564 Administered Twice Daily to Healthy Male and Female Volunteers for 14 Days (27 Doses).
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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00791388). 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.