Clinical Trials/NCT00613431

NCT00613431

Completed

Phase 1

A Randomized, Placebo-Controlled, Single Ascending Dose Study To Assess The Safety, Tolerability and Pharmacokinetics Of CS-8080 In Healthy Volunteers

Daiichi Sankyo1 site in 1 country72 target enrollmentJanuary 2008

ConditionsHealthy

InterventionsCS8080 Placebo

DrugsCS8080 Placebo

Overview

Phase: Phase 1
Intervention: CS8080
Conditions: Healthy
Sponsor: Daiichi Sankyo
Enrollment: 72
Locations: 1
Primary Endpoint: Safety assessed over the 5-day post-dose inpatient period and at a follow-up 1 week post-discharge.
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The main purposes of this study are to assess the safety and measure the pharmacokinetics of CS-8080 in healthy volunteers.

Registry

clinicaltrials.gov

Start Date

January 2008

End Date

August 2008

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

1

6 dose groups, 9 subjects on active, 3 subjects on placebo in each group

Intervention: CS8080

2

3 subjects on placebo in each group

Intervention: Placebo

Outcomes

Primary Outcomes

Safety assessed over the 5-day post-dose inpatient period and at a follow-up 1 week post-discharge.

Time Frame: 2 weeks

Single dose plasma pharmacokinetics of CS-8080

Time Frame: 2 weeks

Secondary Outcomes

Pharmacodynamic response to CS-8080, as assessed by mRNA levels to 24 h post-dose.(2 weeks)

Study Sites (1)

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