SPC3649 Multiple Dose Study in Healthy Volunteers

Phase 1

Completed

• Conditions: Hepatitis C
• Interventions: Drug: saline; Drug: SPC3649

• Registration Number: NCT00979927
• Lead Sponsor: Santaris Pharma A/S

Brief Summary

The purpose of this study is to investigate the safety and tolerability of SPC3649 given in multiple doses to healthy volunteers.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-17
• Study First Submitted QC: 2009-09-17
• Study First Posted: 2009-09-18
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-04
• Last Update Posted: 2011-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Healthy volunteers: Males and postmenopausal females aged ≥ 18 to 60 years

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline	saline	-
SPC3649	SPC3649	-

Primary Outcome Measures

Name	Time	Method
Number of subjects experiencing adverse events	Up to 169 Days

Secondary Outcome Measures

Name	Time	Method
Peak Plasma Concentration (Cmax) of SPC3649	Up to 169 Days
Effect on total Cholesterol	Up to 169 Days

Trial Locations

Locations (1)

PRA international; 🇳🇱 Zuidlaren, Netherlands