Respiratory Syncytial Virus (RSV) Infection MedDRA version: 18.1 Level: LLT Classification code 10039247 Term: RSV infection System Organ Class: 100000004862
Conditions
Interventions
Product Code: GS-5806
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: presatovir
CAS Number: 1353625-73-6
Current Sponsor code: GS-5806
Concentration unit: mg milligram(s)
Concentration t
Sponsors
Gilead Sciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Males and females = 18 years of age who have received a LT (single or double) or heart/lung transplant > 90 days prior to Screening 2) Confirmed to be RSV-positive by local polymerase chain reaction (PCR) testing (starting from when the upper or lower respiratory tract sample is obtained) = 7 days prior to IMP administration on Day 1/Baseline 3) New onset or acute worsening, if the symptom is chronic, of at least 1 of the following respiratory symptoms = 7 days prior to IMP administration on Day 1/Baseline: nasal congestion, earache, runny nose, cough, sore throat, shortness of breath, or wheezing 4) An informed consent document signed and dated by the subject 5) A negative urine or serum pregnancy test for female subjects of childbearing potential (unless surgically sterile or greater than 2 years post-menopause) at Screening or prior to Randomization on Day 1/Baseline 6) Agreement from male and female subjects of childbearing potential who engage in heterosexual intercourse to use protocol specified method(s) of contraception as described in Appendix 6 of the protocol 7) Ability and willingness to complete necessary study procedures Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 45
Exclusion criteria
Exclusion criteria: Related to concomitant or previous medication use: 1) Use of any investigational agents within 30 days, OR use of any investigational monoclonal anti-RSV antibodies within 4 months or 5 half-lives of Screening, whichever is longer, OR use of any prior investigational RSV vaccines 2) Use of a strong or moderate cytochrome P450 enzyme (CYP) inducer including but not limited to rifampin, St. John’s Wort, carbamazepine, phenytoin, efavirenz, bosentan, etravirine, modafinil, and nafcillin, within 2 weeks prior to the first dose of IMP 3) Use of any of the following lympholytic treatment within the stated time frame: anti-thymocyte globulin (ATG), 5 times the ULN obtained in screening laboratory measurements or via local laboratory measurements obtained = 7 days prior to Screening 18) Clinically signi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the effect of presatovir on nasal RSV viral load in RSV-positive LT recipients with acute respiratory symptoms;Secondary Objective: - To evaluate the effect of presatovir on clinical sequelae of RSV infection and on measures of lung function - To evaluate the pharmacokinetics (PK), safety, and tolerability of presatovir;Primary end point(s): The co-primary efficacy endpoints are: - The time-weighted average change in log10 viral load from Day 1/Baseline through Day 7 (DAVG7) as measured in nasal samples by RT-qPCR among subjects in the FAS - Time-weighted average change in log10 viral load from Day 1/Baseline through Day 7 (DAVG7) as measured in nasal samples by RT-qPCR in a subset of FAS subjects whose duration of RSV symptoms prior to the first dose of study medication is = median;Timepoint(s) of evaluation of this end point: Day 1 and Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Time-weighted average change in FLU-PRO score from Day 1/Baseline through Day 7 - Percent change from Day 1/Baseline in FEV1% predicted value at Day 28/End of Study;Timepoint(s) of evaluation of this end point: Day 1 and Day 7 Day 1 and Day 28 | — |
Countries
Australia, Austria, Belgium, Canada, France, Germany, Netherlands, United Kingdom, United States
Contacts
Public ContactClinical Trials Mailbox
Gilead Sciences International Ltd.
Outcome results
None listed