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A Study to Evaluate the Safety, Pharmacokinetics and Antiviral Effects of Galidesivir in Yellow Fever

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ClinicalTrials.gov Identifier: NCT03891420
Recruitment Status : Not yet recruiting
First Posted : March 27, 2019
Last Update Posted : March 27, 2019
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
BioCryst Pharmaceuticals

Brief Summary:
This is a placebo-controlled, randomized, double-blind study to evaluate the pharmacokinetics, safety and antiviral activity of galidesivir in subjects with yellow fever (YF).

Condition or disease Intervention/treatment Phase
Yellow Fever Drug: Galidesivir Drug: Placebo Phase 1

Detailed Description:
This is a randomized, double-blind, placebo-controlled dose-ranging study to evaluate the pharmacokinetics (PK), safety, and antiviral effects of galidesivir administered via intravenous (IV) infusion vs. placebo in adult subjects with Yellow fever (YF). The study will be conducted in two parts. Part 1 will be a dose ranging study where subjects with YF will be administered escalating dose regimens of galidesivir twice daily for 7 days. Eight subjects will be enrolled in each cohort: 6 to receive galidesivir and 2 will receive placebo. Part 2 of the study is an expansion cohort, where the optimized regimen of galidesivir will be administered to more subjects randomized in a 2:1 manner to galidesivir or placebo. The optimized regimen will be selected based on safety, viral load reduction, improvement in YF signs and symptoms and mortality. Thirty subjects are planned for Part 2.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1b Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Safety, Pharmacokinetics, and Anti-viral Effects of Galidesivir Administered Via Intravenous Infusion to Subjects With Yellow Fever
Estimated Study Start Date : April 15, 2019
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : July 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arm Intervention/treatment
Experimental: Galidesivir
Galidesivir IV infusion
Drug: Galidesivir
Galidesivir IV infusion

Placebo Comparator: Placebo
Placebo IV infusion
Drug: Placebo
Placebo IV infusion




Primary Outcome Measures :
  1. number of subjects with treatment emergent adverse events and serious adverse events [ Time Frame: absolute number through the end of the study, approximately 56 days ]
  2. number of subjects with change in laboratory parameters [ Time Frame: absolute number and change from baseline through the end of the study, approximately 56 days ]
  3. exposure of galidesivir as measured by plasma concentrations [ Time Frame: 24 hours post dose on Day 1 through 12 hours post dose on Day 7 ]

Secondary Outcome Measures :
  1. yellow fever virus (YFV) titer [ Time Frame: change in YFV titer from baseline through Day 21 ]
  2. mortality [ Time Frame: mortality at Day 56 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability to provide written informed consent
  • Males and nonpregnant, non-breast-feeding females, aged 18 years or older
  • Subject weight ≥ 50 kg (110 lb.)
  • Positive test for YFV by molecular amplification of the virus in the blood
  • First onset of symptoms of YF occurring within the previous 7 days
  • Male and female subjects must agree to the contraception requirements and must meet the inclusion criteria regarding contraception as outlined in the protocol
  • CLCR of at least 60 mL/min by Cockcroft-Gault equation
  • AST < 5000 u/L
  • Indirect bilirubin < 1.5 mg/dL
  • Neutrophil count < 7500 /mm3
  • International Normalized Ratio (INR) < 1.5

Exclusion Criteria:

  • Any clinically significant medical condition or medical history that, in the opinion of the investigator or sponsor, would interfere with the subject's ability to participate in the study or increase the risk of participation for that subject
  • Employment by the study site, or an immediate family relationship to either study site employees or Sponsor employee
  • Lack of suitable veins for venipuncture/cannulation as assessed by the Investigator at Screening
  • Participation in any other investigational drug or vaccine study currently or within the past 30 days
  • Diagnosis of YF vaccine-related viscerotropic disease
  • Subjects with hepatic encephalopathy as defined by Conn Score ≥ 1.
  • Subject has severe immunosuppression or immunodeficiency, leukemia, lymphoma, thymic disease, generalized malignancy, or radiation therapy (within the past 3 months), or is undergoing current treatment with immunosuppressive drugs, defined as drugs that impair immune responses to infections
  • A treatment plan for YF that would include concomitant administration of antiviral medications

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): NCT03891420


Contacts
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Contact: Study Director 919-859-1302 clinicaltrials@biocryst.com

Locations
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Brazil
Clinical Research Unit and Department of Infectious and Parasitic Diseases Hospital das Clínicas, School of Medicine, USP Not yet recruiting
São Paulo, SP, Brazil, 05403-010
Sponsors and Collaborators
BioCryst Pharmaceuticals
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Esper Kallas, MD, PhD University of Sao Paulo, Brazil

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Responsible Party: BioCryst Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03891420     History of Changes
Other Study ID Numbers: BCX4430-108
272201300017C-18-0-1 ( U.S. NIH Grant/Contract )
DMID18-0022 ( Other Identifier: NIAID )
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Yellow Fever
Fever
Body Temperature Changes
Signs and Symptoms
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral