NCT00688012

Brief Summary

A placebo-controlled, double-blind, randomized, single dose, dose escalating trial in healthy men to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SPC3649.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2008

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 2, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

September 18, 2009

Status Verified

September 1, 2009

Enrollment Period

1 year

First QC Date

May 7, 2008

Last Update Submit

September 17, 2009

Conditions

Hepatitis C

Keywords

antisensemicroRna antagonistanti-miR-122Safety in healthy volunteersHepatitis C

Interventions

SPC3649DRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Volunteers
  • BMI: 19-28 kg/m2
  • No clinically significant disease/disorder
  • Screening laboratory tests without clinically significant abnormalities, must agree to use condoms during intercourse for one week after study drug infusion
  • Following receipt of verbal and written information about the study, the subject must provide signed informed consent before any study related activity is carried out.

You may not qualify if:

  • Heavy exercise within the past 7 days
  • Alcohol intake\> 21 units weekly
  • Regular smoker
  • Received experimental drug within 30 days of study entry
  • Planned participation in any experimental study during the study period
  • HIV-Ab, HBsAg and/or HCV Ab positive
  • History of specific allergy
  • Current use of any drug or narcotics.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PhaseOne Trials, Hvidovre University Hospital

Hvidovre, DK-2650, Denmark

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

miravirsen

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 7, 2008

First Posted

June 2, 2008

Study Start

May 1, 2008

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

September 18, 2009

Record last verified: 2009-09

Locations

DK(1)