Safety and Efficacy Study of GS-5806 in Healthy Volunteers Infected With Respiratory Syncytial Virus (RSV)

NCT ID: NCT01756482

Last Updated: 2015-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-06-30

Brief Summary

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

Detailed Description

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Conditions

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Respiratory Syncytial Virus Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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GS-5806

GS-5806, powder for oral solution

Group Type EXPERIMENTAL

GS-5806

Intervention Type DRUG

GS-5806, powder for oral solution

Sugar powder for oral solution in juice

Sugar powder for oral solution

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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GS-5806

GS-5806, powder for oral solution

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adeyi Adeyemi, MD

Role: PRINCIPAL_INVESTIGATOR

Retroscreen Virology

Locations

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Retroscreen Virology

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 25140957 (View on PubMed)

Other Identifiers

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GS-US-218-0103

Identifier Type: -

Identifier Source: org_study_id

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