SPC3649 Multiple Dose Study in Healthy Volunteers

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Santaris Pharma A/S

ClinicalTrials.gov Identifier:

NCT00979927

First received: September 17, 2009

Last updated: October 4, 2011

Last verified: October 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

September 17, 2009

Last Updated Date

October 4, 2011

Start Date ^ICMJE

September 2009

Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of subjects experiencing adverse events [ Time Frame: Up to 169 Days ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00979927 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Peak Plasma Concentration (Cmax) of SPC3649 [ Time Frame: Up to 169 Days ] [ Designated as safety issue: No ]
Effect on total Cholesterol [ Time Frame: Up to 169 Days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

SPC3649 Multiple Dose Study in Healthy Volunteers

Official Title ^ICMJE

A Placebo-controlled Double-blind, Randomised, Multiple Dose, Dose Escalating Study in Healthy Subjects to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPC3649

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Hepatitis C

Intervention ^ICMJE

Drug: SPC3649
5 weekly doses
Drug: saline
5 weekly doses

Study Arm (s)

Placebo Comparator: Saline
Intervention: Drug: saline
Active Comparator: SPC3649
Intervention: Drug: SPC3649

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

September 2010

Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT Number ^ICMJE

NCT00979927

Other Study ID Numbers ^ICMJE

SPC3649-202, Eudract no 2009-012153-38

Has Data Monitoring Committee

Responsible Party

Santaris Pharma A/S

Study Sponsor ^ICMJE

Santaris Pharma A/S

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Salah Hadi, MD,MSc

PRA International

Information Provided By

Santaris Pharma A/S

Verification Date

October 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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