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

This study has been completed.
Sponsor:
Information provided by:
Procter and Gamble
ClinicalTrials.gov Identifier:
NCT00791388
First received: November 13, 2008
Last updated: September 27, 2011
Last verified: September 2011
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 26, 2014