Multiple Rising Oral Dose Study of PG 760564 Administered Twice Daily to Healthy Male/Female Volunteers for 14 Days - Full Text View

Purpose

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).

Condition	Intervention	Phase
Healthy	Drug: Placebo Drug: PG-760564	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator)
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).

Further study details as provided by Procter and Gamble:

Primary Outcome Measures:

AUCτ Over a Dosing Interval (τ = 12 Hours) on Day 14 [ Time Frame: 14 days ] [ Designated as safety issue: No ]
the area under the plasma concentration-time curve over a dosing interval (τ = 12 hours) on Day 14 of Multiple Dose Oral Administration of PG-760564 Given Every 12 Hours
Cmax Over a Dosing Interval (τ = 12 Hours)on Day 14 [ Time Frame: 12 hours on Day 14 ] [ Designated as safety issue: No ]
Maximum plasma concentration (Cmax) over a dosing interval (τ = 12 hours)on Day 14
Tmax Over a Dosing Interval (τ = 12 Hours) on Day 14 [ Time Frame: 12 Hours on Day 14 ] [ Designated as safety issue: No ]
the time at which maximum plasma concentration occurred (Tmax) Over a Dosing Interval (τ = 12 Hours) on Day 14
t½,z Over a Dosing Interval (τ = 12 Hours)on Day 14 [ Time Frame: over a Dosing Interval (τ = 12 Hours) on Day 14 ] [ Designated as safety issue: No ]
t½,z is the terminal exponential half-life; over a Dosing Interval (τ = 12 Hours)on Day 14

Enrollment:	45
Study Start Date:	August 2005
Study Completion Date:	January 2006
Primary Completion Date:	January 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: placebo placebo capsule	Drug: Placebo oral capsule, 2x/day for 14 days
Experimental: 50 mg PG 760564 50 mg PG 760564 active	Drug: PG-760564 oral capsule, 50 mg, 2x/day for 14 days
Experimental: 100 mg PG 760564 100 mg PG 760564 active	Drug: PG-760564 oral capsule, 100mg, 2x/day for 14 days
Experimental: 200 mg PG 760564 200 mg PG 760564 active	Drug: PG-760564 oral capsule, 200 mg, 2x/day for 14 days
Experimental: 400 mg PG 760564 400 mg PG 760564 active	Drug: PG-760564 oral capsule, 400 mg, 2x/day for 14 days

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

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00791388

Locations

United States, Florida
Stuart I Harris, MD, PhD
Miami, Florida, United States, 33126

Sponsors and Collaborators

Procter and Gamble

Investigators

Study Director:

William S Aronstein, MD, PhD

Procter and Gamble

More Information

No publications provided

Responsible Party:	William S Aronstein, PhD, MD, Procter and Gamble Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00791388 History of Changes
Other Study ID Numbers:	2005046
Study First Received:	November 13, 2008
Results First Received:	August 3, 2011
Last Updated:	September 27, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Procter and Gamble:

Pharmacokinetics

ClinicalTrials.gov processed this record on May 19, 2013