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

Procter & Gamble (P&G)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: PG-760564

Study type: Interventional

Funder types: Industry

Identifiers

NCT00791388

2005046

Details and patient eligibility

About

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).

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

45 participants in 5 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

placebo capsule

Treatment:

Drug: Placebo

50 mg PG 760564

Experimental group

Description:

50 mg PG 760564 active

Treatment:

Drug: PG-760564

Drug: PG-760564

Drug: PG-760564

Drug: PG-760564

100 mg PG 760564

Experimental group

Description:

100 mg PG 760564 active

Treatment:

Drug: PG-760564

Drug: PG-760564

Drug: PG-760564

Drug: PG-760564

200 mg PG 760564

Experimental group

Description:

200 mg PG 760564 active

Treatment:

Drug: PG-760564

Drug: PG-760564

Drug: PG-760564

Drug: PG-760564

400 mg PG 760564

Experimental group

Description:

400 mg PG 760564 active

Treatment:

Drug: PG-760564

Drug: PG-760564

Drug: PG-760564

Drug: PG-760564