NCT00791388

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Aug 2005

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2008

Completed
3 years until next milestone

Results Posted

Study results publicly available

November 4, 2011

Completed
Last Updated

November 4, 2011

Status Verified

September 1, 2011

Enrollment Period

5 months

First QC Date

November 13, 2008

Results QC Date

August 3, 2011

Last Update Submit

September 27, 2011

Conditions

Healthy

Keywords

Pharmacokinetics

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (5)

placebo

PLACEBO COMPARATOR

placebo capsule

Drug: Placebo

50 mg PG 760564

EXPERIMENTAL

50 mg PG 760564 active

Drug: PG-760564

100 mg PG 760564

EXPERIMENTAL

100 mg PG 760564 active

Drug: PG-760564

200 mg PG 760564

EXPERIMENTAL

200 mg PG 760564 active

Drug: PG-760564

400 mg PG 760564

EXPERIMENTAL

400 mg PG 760564 active

Drug: PG-760564

Interventions

PlaceboDRUG

oral capsule, 2x/day for 14 days

placebo
PG-760564DRUG

oral capsule, 50 mg, 2x/day for 14 days

50 mg PG 760564

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stuart I Harris, MD, PhD

Miami, Florida, 33126, United States

Location

Results Point of Contact

Title
Peter Thomas
Organization
Procter & Gamble
thomas.pr@pg.com
513.622.4838

Study Officials

  • William S Aronstein, MD, PhD

    Procter and Gamble

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 13, 2008

First Posted

November 14, 2008

Study Start

August 1, 2005

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

November 4, 2011

Results First Posted

November 4, 2011

Record last verified: 2011-09

Locations

US(1)