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A Study to Evaluate the Single Dose Safety, Tolerability and Pharmacokinetics of IV BCX4430

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03800173
Recruitment Status : Recruiting
First Posted : January 11, 2019
Last Update Posted : January 11, 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 of galidesivir following administration of single doses by IV infusion

Condition or disease Intervention/treatment Phase
Marburg Virus Disease Drug: galidesivir Drug: placebo Phase 1

Detailed Description:
This single ascending dose study will evaluate the safety, tolerability, and PK of single doses of galidesivir vs. placebo administered as IV infusions in healthy subjects enrolled in up to four dose cohorts of 8 subjects each. A single dose of study drug will be administered per cohort: 6 subjects will receive galidesivir IV, and 2 subjects will receive matching placebo.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1 Double-blind, Placebo Controlled, Dose Ranging Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Galidesivir (BCX4430) Administered as Single Doses Via Intravenous Infusion in Healthy Subjects
Actual Study Start Date : December 10, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


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 and percent of subjects with treatment emergent adverse events and serious adverse events [ Time Frame: absolute number and change from baseline through the end of the study, approximately 21 days ]
  2. number and percent of subjects with laboratory abnormalities [ Time Frame: absolute number and change from baseline through the end of the study, approximately 21 days ]
  3. number and percentage of subjects with electrocardiogram changes in PR, QRS, QT, RR and QTcF intervals [ Time Frame: absolute and change from baseline through the end of the study, approximately 21 days ]
  4. number and percent of subjects with changes to echocardiogram [ Time Frame: absolute and change from baseline through day 4 ]
  5. number and percent of subjects with changes following 24 hour cardiac telemetry [ Time Frame: absolute and change from baseline through 24 hours ]

Secondary Outcome Measures :
  1. plasma PK parameters - Cmax (maximum plasma concentration) [ Time Frame: plasma PK parameters are based on sampling over a 21 day period ]
  2. plasma PK parameters - AUC (Area under the curve) [ Time Frame: plasma PK parameters are based on sampling over a 21 day period ]
  3. renal clearance [ Time Frame: urine PK parameters are based on sampling over a 5 day period ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  • written informed consent
  • males and non-pregnant, non-lactating females
  • BMI 19.0-32.0
  • willing to abide by contraceptive requirements
  • normal vitals
  • willing to abide by study procedures and restrictions

Exclusion Criteria:

  • clinically significant medical condition or medical history or psychiatric condition or history of psychiatric condition
  • abnormal cardiac finding, or laboratory/urinalysis abnormality at screening
  • known family history of sudden death or long QT syndrome, family or personal history of QT prolongation, or arrhythmia that required medical intervention
  • current participation in any other investigational drug study or participation in an investigational drug study within 3 months of screening visit
  • use of prescription, OTC, or herbal medications during study or use of any specified medications within 30 days prior to study
  • Recent or current history of alcohol or drug abuse
  • Regular use of tobacco or nicotine products
  • Positive serology for HBV, HCV, or HIV
  • history of severe adverse reaction to or known sensitivity to any drug
  • pregnant, lactating, or planning to become pregnant within 30 days of the study. Male subjects with pregnant female partners are excluded

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): NCT03800173


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

Locations
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United States, Kansas
PRA Health Sciences Recruiting
Lenexa, Kansas, United States, 66219
Contact: Recruitment Center         
Sponsors and Collaborators
BioCryst Pharmaceuticals
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Daniel Dickerson, MD, PhD PRA Health Sciences

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Responsible Party: BioCryst Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03800173    
Other Study ID Numbers: BCX4430-106
DMID18-0013 ( Other Identifier: NIAID )
272201300017C-18-0-1 ( U.S. NIH Grant/Contract )
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 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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Marburg Virus Disease
Virus Diseases
Hemorrhagic Fevers, Viral
RNA Virus Infections
Filoviridae Infections
Mononegavirales Infections