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

Study Overview
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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.

Official Title
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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).

Conditions
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Healthy

Intervention / Treatment
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* Drug: Placebo
* Drug: PG-760564
* Drug: PG-760564
* Drug: PG-760564
* Drug: PG-760564


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>placebo capsule | Drug: Placebo<br>* oral capsule, 2x/day for 14 days<br>|
| Experimental: 50 mg PG 760564<br>50 mg PG 760564 active | Drug: PG-760564<br>* oral capsule, 50 mg, 2x/day for 14 days<br>|
| Experimental: 100 mg PG 760564<br>100 mg PG 760564 active | Drug: PG-760564<br>* oral capsule, 100mg, 2x/day for 14 days<br>|
| Experimental: 200 mg PG 760564<br>200 mg PG 760564 active | Drug: PG-760564<br>* oral capsule, 200 mg, 2x/day for 14 days<br>|
| Experimental: 400 mg PG 760564<br>400 mg PG 760564 active | Drug: PG-760564<br>* oral capsule, 400 mg, 2x/day for 14 days<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics