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

NCT00791388 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2011-11-04

Study results available
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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).

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Procter and Gamble

    lead INDUSTRY

Principal Investigators

  • William S Aronstein, MD, PhD · Procter and Gamble

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2006-01-31
Completion
2006-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00791388 on ClinicalTrials.gov