NCT00791388

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

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).

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Procter and Gamble · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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).

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Placebo	oral capsule, 2x/day for 14 days
DRUG	PG-760564	oral capsule, 50 mg, 2x/day for 14 days
DRUG	PG-760564	oral capsule, 100mg, 2x/day for 14 days
DRUG	PG-760564	oral capsule, 200 mg, 2x/day for 14 days
DRUG	PG-760564	oral capsule, 400 mg, 2x/day for 14 days

Timeline

• Start date: 2005-08-01
• Primary completion: 2006-01-01
• Completion: 2006-01-01
• First posted: 2008-11-14
• Last updated: 2011-11-04
• Results posted: 2011-11-04

Locations

1 site across 1 country: United States