Clinical trial NCT00791388: Multiple Rising Oral Dose Study of PG 760564 Administered Twice Daily to Healthy Male/Female Volunteers for 14 Days
Official title: Multiple Ascending Oral Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of PG 760564 Administered Twice Daily to Healthy Male and Female Volunteers for 14 Days (27 Doses).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Pharmacokinetics
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2008-11-14
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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).

Detailed description: 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). The study is a multiple rising dose (MRD) study of active drug vs. placebo.

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

Primary outcomes:
measure: AUCτ Over a Dosing Interval (τ = 12 Hours) on Day 14
timeFrame: 14 days
measure: Cmax Over a Dosing Interval (τ = 12 Hours)on Day 14
timeFrame: 12 hours on Day 14
measure: Tmax Over a Dosing Interval (τ = 12 Hours) on Day 14
timeFrame: 12 Hours on Day 14
measure: t½,z Over a Dosing Interval (τ = 12 Hours)on Day 14
timeFrame: over a Dosing Interval (τ = 12 Hours) on Day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Stuart I Harris, MD, PhD
state: Florida
Study officials:
affiliation: Procter and Gamble
name: William S Aronstein, MD, PhD
role: STUDY_DIRECTOR
References: