Effects of CS-8080 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: CS8080; Drug: Placebo

• Registration Number: NCT00613431
• Lead Sponsor: Daiichi Sankyo

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-31
• Study First Submitted QC: 2008-02-12
• Study First Posted: 2008-02-13
• Primary Completion: 2008-08
• Status Verified: 2008-12
• Last Update Submitted: 2018-12-19
• Last Update Posted: 2018-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	CS8080	6 dose groups, 9 subjects on active, 3 subjects on placebo in each group
2	Placebo	3 subjects on placebo in each group

Primary Outcome Measures

Name	Time	Method
Safety assessed over the 5-day post-dose inpatient period and at a follow-up 1 week post-discharge.	2 weeks
Single dose plasma pharmacokinetics of CS-8080	2 weeks

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamic response to CS-8080, as assessed by mRNA levels to 24 h post-dose.	2 weeks

Trial Locations

Locations (1)

MDS Pharma Services; 🇺🇸 Neptune, New Jersey, United States