NCT01756482

Brief Summary

This study is to evaluate the antiviral effect of GS-5806 in healthy adults infected with a strain of Respiratory Syncytial Virus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2012

Shorter than P25 for phase_2

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

November 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 27, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

August 21, 2015

Status Verified

August 1, 2015

Enrollment Period

7 months

First QC Date

December 20, 2012

Last Update Submit

August 3, 2015

Conditions

Respiratory Syncytial Virus Infections

Keywords

RespiratorySyncytialVirusInfectionsRSV

Outcome Measures

Primary Outcomes (1)

  • Change in viral load measurements.

    Area under the curve for viral load as measured by qRT-PCR assay from the first viral load measurement post initial dose of GS-5806 or placebo through day 12.

    Post initial dose of GS-5806/placebo to Day 12

Secondary Outcomes (1)

  • Change of baseline symptoms

    Innoculation through Day 12

Study Arms (2)

GS-5806

EXPERIMENTAL

GS-5806, powder for oral solution

Drug: GS-5806

Sugar powder for oral solution in juice

PLACEBO COMPARATOR

Sugar powder for oral solution

Drug: Placebo

Interventions

GS-5806DRUG

GS-5806, powder for oral solution

GS-5806
PlaceboDRUG
Sugar powder for oral solution in juice

Eligibility Criteria

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

You may qualify if:

  • Healthy male or female
  • Between 18 to 45 years old
  • Body Mass Index of 18 to 33 kg/m2

You may not qualify if:

  • Acute or chronic medical illness
  • Positive for Human Immunodeficiency Virus, Hepatitis B or C
  • Nose or nasopharynx abnormalities
  • Abnormal lung function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Retroscreen Virology

London, E12AX, United Kingdom

Location

Related Publications (1)

  • DeVincenzo JP, Whitley RJ, Mackman RL, Scaglioni-Weinlich C, Harrison L, Farrell E, McBride S, Lambkin-Williams R, Jordan R, Xin Y, Ramanathan S, O'Riordan T, Lewis SA, Li X, Toback SL, Lin SL, Chien JW. Oral GS-5806 activity in a respiratory syncytial virus challenge study. N Engl J Med. 2014 Aug 21;371(8):711-22. doi: 10.1056/NEJMoa1401184.

    PMID: 25140957DERIVED

MeSH Terms

Conditions

Respiratory Syncytial Virus InfectionsVirus DiseasesInfections

Interventions

presatovir

Condition Hierarchy (Ancestors)

Pneumovirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus Infections

Study Officials

  • Adeyi Adeyemi, MD

    Retroscreen Virology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2012

First Posted

December 27, 2012

Study Start

November 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

August 21, 2015

Record last verified: 2015-08

Locations

GB(1)