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

NCT ID: NCT00791388

Last Updated: 2011-11-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2006-01-31

Brief Summary

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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

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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placebo

placebo capsule

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral capsule, 2x/day for 14 days

50 mg PG 760564

50 mg PG 760564 active

Group Type EXPERIMENTAL

PG-760564

Intervention Type DRUG

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

100 mg PG 760564

100 mg PG 760564 active

Group Type EXPERIMENTAL

PG-760564

Intervention Type DRUG

oral capsule, 100mg, 2x/day for 14 days

200 mg PG 760564

200 mg PG 760564 active

Group Type EXPERIMENTAL

PG-760564

Intervention Type DRUG

oral capsule, 200 mg, 2x/day for 14 days

400 mg PG 760564

400 mg PG 760564 active

Group Type EXPERIMENTAL

PG-760564

Intervention Type DRUG

oral capsule, 400 mg, 2x/day for 14 days

Interventions

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Placebo

oral capsule, 2x/day for 14 days

Intervention Type DRUG

PG-760564

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

Intervention Type DRUG

PG-760564

oral capsule, 100mg, 2x/day for 14 days

Intervention Type DRUG

PG-760564

oral capsule, 200 mg, 2x/day for 14 days

Intervention Type DRUG

PG-760564

oral capsule, 400 mg, 2x/day for 14 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Procter and Gamble

INDUSTRY

Sponsor Role lead

Responsible Party

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Procter and Gamble Pharmaceuticals

Principal Investigators

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William S Aronstein, MD, PhD

Role: STUDY_DIRECTOR

Procter and Gamble

Locations

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Stuart I Harris, MD, PhD

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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2005046

Identifier Type: -

Identifier Source: org_study_id