Study Comparing the Safety of ASP2151 to Valacyclovir and Placebo in Healthy Volunteers

Conditions

• Safety of ASP2151

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Accepted

Interventions

• ASP2151 — DRUG
  Oral
• Valacyclovir — DRUG
  Oral
• Placebo — DRUG
  Oral

Study Details

The objective of the study is to compare the safety of ASP2151 to valacyclovir and placebo in healthy male and female adult volunteers.

Key Dates

Start date

Mar 31, 2009

Status verified

Jun 2010

Primary completion

Apr 30, 2010

Completion

Apr 30, 2010

Study Design

Enrollment

442 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Arms

• Experimental: 1. ASP2151
• Active Comparator: 2. Valacyclovir
• Placebo Comparator: 3. Placebo

Primary Outcome Measure

Assessment of clinical laboratory evaluations and adverse events [ Time Frame: Days 1,4,7,10,14,17,21,24, 28 and follow-up visit ]

Locations (5)