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Pharmacokinetics and Safety of RV521 Formulations (C19007)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04065698
Recruitment Status : Completed
First Posted : August 22, 2019
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
ReViral Ltd

Brief Summary:
The main aims of the study are to assess the pharmacokinetics and safety of single doses of RV521 administered as two different formulations

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus Infections Drug: RV521 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An Open-label, Single Dose, Three Sequence Study in Healthy Adult Volunteers to Evaluate the Pharmacokinetics, Safety and Tolerability of RV521 Administered as the Drug in Capsule Formulation in the Fed State and the Dry Powder Blend Formulation Dispersed in Water in the Fed and Fasted States
Actual Study Start Date : August 13, 2019
Actual Primary Completion Date : September 2, 2019
Actual Study Completion Date : September 9, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RV521
Three single 200 mg oral doses of RV521 administered on Day 1, Day 5 and Day 9 as either the drug in capsule (1 dosing occasion) or the dry powder blend dispersed in water (2 dosing occasions)
Drug: RV521
Single doses of RV521 administered as the drug in capsule formulation when fed and as the dry powder blend formulation dispersed in water when fed and whilst fasting, each on a separate dosing day.
Other Name: Sisunatovir




Primary Outcome Measures :
  1. Time to maximum plasma concentration (tmax) for RV521 [ Time Frame: Baseline to study day 11 ]
  2. Terminal half life (t1/2) for RV521 [ Time Frame: Baseline to study day 11 ]
  3. Maximum observed plasma concentration (Cmax) for RV521 [ Time Frame: Baseline to study day 11 ]
  4. Area under the plasma concentration-time curve from time zero to last detectable plasma concentration (AUC0-t) for RV521 [ Time Frame: Baseline to study day 11 ]
  5. Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) for RV521 [ Time Frame: Baseline to study day 11 ]

Secondary Outcome Measures :
  1. Incidence of treatment emergent adverse events as assessed by CTCAE V5.0 [ Time Frame: Screening to final study visit (performed at 7 days following the last dose of any intervention) ]
  2. Proportion of subjects with clinically significant changes in laboratory safety tests (haematology, chemistry, coagulation and urinalysis) [ Time Frame: Screening to final study visit (performed at 7 days following the last dose of any intervention) ]
  3. Proportion of subjects with morphological and/or rhythm abnormalities on ECG [ Time Frame: Screening to final study visit (performed at 7 days following the last dose of any intervention) ]
  4. Proportion of subjects with clinically significant changes in ECG time intervals (PR, QRS, QT and QTc intervals) [ Time Frame: Screening to final study visit (performed at 7 days following the last dose of any intervention) ]
  5. Proportion of subjects with clinically significant changes in vital signs (systolic blood pressure, diastolic blood pressure and pulse rate) [ Time Frame: Screening to final study visit (performed at 7 days following the last dose of any intervention) ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Willing to comply with protocol defined contraception requirements
  • In good health with no history of major medical conditions
  • A body mass index (BMI) of 18-25 kg/m^2, inclusive

Exclusion Criteria:

  • Evidence of any clinically significant or currently active major medical condition
  • Positive test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening
  • Not willing to comply with protocol defined restrictions for intake of drugs of abuse, alcohol, nicotine-containing products, medication (prescription, OTC, herbal, vitamins/minerals etc) and specified food and drink products

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04065698


Locations
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United Kingdom
Richmond Pharmacology Ltd
London, United Kingdom, SE1 1YR
Sponsors and Collaborators
ReViral Ltd
Investigators
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Principal Investigator: Lorch, MD Richmond Pharmacology Limited
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Responsible Party: ReViral Ltd
ClinicalTrials.gov Identifier: NCT04065698    
Other Study ID Numbers: REVC005
2019-000976-40 ( EudraCT Number )
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Syncytial Virus Infections
Virus Diseases
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections