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

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).

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).

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: PG-760564; Drug: PG-760564; Drug: PG-760564; Drug: PG-760564

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Drug: PG-760564; oral capsule, 100mg, 2x/day for 14 days; Drug: PG-760564; oral capsule, 200 mg, 2x/day for 14 days; Drug: PG-760564; oral capsule, 400 mg, 2x/day for 14 days
Experimental: 100 mg PG 760564; 100 mg PG 760564 active	Drug: PG-760564; oral capsule, 50 mg, 2x/day for 14 days; Drug: PG-760564; oral capsule, 100mg, 2x/day for 14 days; Drug: PG-760564; oral capsule, 200 mg, 2x/day for 14 days; Drug: PG-760564; oral capsule, 400 mg, 2x/day for 14 days
Experimental: 200 mg PG 760564; 200 mg PG 760564 active	Drug: PG-760564; oral capsule, 50 mg, 2x/day for 14 days; Drug: PG-760564; oral capsule, 100mg, 2x/day for 14 days; Drug: PG-760564; oral capsule, 200 mg, 2x/day for 14 days; Drug: PG-760564; oral capsule, 400 mg, 2x/day for 14 days
Experimental: 400 mg PG 760564; 400 mg PG 760564 active	Drug: PG-760564; oral capsule, 50 mg, 2x/day for 14 days; Drug: PG-760564; oral capsule, 100mg, 2x/day for 14 days; Drug: PG-760564; oral capsule, 200 mg, 2x/day for 14 days; Drug: PG-760564; oral capsule, 400 mg, 2x/day for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCτ Over a Dosing Interval (τ = 12 Hours) on Day 14	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	14 days
Cmax Over a Dosing Interval (τ = 12 Hours)on Day 14	Maximum plasma concentration (Cmax) over a dosing interval (τ = 12 hours)on Day 14	12 hours on Day 14
Tmax Over a Dosing Interval (τ = 12 Hours) on Day 14	the time at which maximum plasma concentration occurred (Tmax) Over a Dosing Interval (τ = 12 Hours) on Day 14	12 Hours on Day 14
t½,z Over a Dosing Interval (τ = 12 Hours)on Day 14	t½,z is the terminal exponential half-life; over a Dosing Interval (τ = 12 Hours)on Day 14	over a Dosing Interval (τ = 12 Hours) on Day 14

Collaborators and Investigators

• Sponsor: Procter and Gamble
• Investigators: Study Director: William S Aronstein, MD, PhD, Procter and Gamble

Study record dates

Study Major Dates

• Study Start: August 1, 2005
• Primary Completion (Actual): January 1, 2006
• Study Completion (Actual): January 1, 2006

Study Registration Dates

• First Submitted: November 13, 2008
• First Submitted That Met QC Criteria: November 13, 2008
• First Posted (Estimate): November 14, 2008

Study Record Updates

• Last Update Posted (Estimate): November 4, 2011
• Last Update Submitted That Met QC Criteria: September 27, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: Pharmacokinetics
• Other Study ID Numbers: 2005046