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A Phase 1 Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BCX4430 Administered Via Intramuscular Injection (IM) in Healthy Subjects

Trial Profile

A Phase 1 Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BCX4430 Administered Via Intramuscular Injection (IM) in Healthy Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 09 May 2019

At a glance

  • Drugs Galidesivir (Primary)
  • Indications Ebola virus infections; Marburg virus disease; Middle East respiratory syndrome coronavirus; Yellow fever
  • Focus Adverse reactions; First in man
  • Sponsors BioCryst Pharmaceuticals
  • Most Recent Events

    • 05 May 2016 Status changed from recruiting to completed, as per BioCryst media release.
    • 08 May 2015 According to Biocryst media release, safety and pharmacokinetic/phamacodynamic results from this trial are expected in the third quarter of 2015.
    • 08 May 2015 According to Biocryst media release, this trial is funded by NIAID.

Trial Overview

Purpose

This is a 2-part, first-in-human dose-ranging study to evaluate the safety, tolerability and pharmacokinetics of escalating doses of BCX4430 administered via intramuscular (IM) injection in healthy subjects. In part 1, subjects will receive a single dose of BCX4430; in part 2 subjects will receive BCX4430 for 7 days.

Comments

This trial is funded by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health in the US.

Primary Endpoints

Safety, measured by the frequency and severity of adverse events, laboratory abnormalities and other safety parameters following single (Part 1) and multiple (Part 2) doses of BCX4430

safety_issue: Yes
description: Evaluation of the incidence and severity of adverse events, laboratory abnormalities, ECG findings, vital sign changes, injection site and physical examination findings
time_frame: Part 1: 7 days. Part 2: 14 days

Other Endpoints

Plasma exposure of BCX4430, determined by the concentration time profile and PK parameters following single (Part 1) and multiple (Part 2) doses of BCX4430

safety_issue: No
time_frame: Part 1: 7 days. Part 2: 14 days

The urinary elimination of BCX4430, determined by the concentration of drug following single (Part 1) and multiple (Part 2) doses of BCX4430

safety_issue: No
time_frame: Part 1: 7 days. Part 2: 14 days

The levels of BCX6870, the triphosphate metabolite of BCX4430, in peripheral blood mononuclear cells following single (Part 1) and multiple (Part 2) doses of BCX4430

safety_issue: No
time_frame: Part 1: 7 days. Part 2: 14 days [1]

Diseases Treated

Indication Qualifiers Patient Segments
Ebola virus infections treatment -
Marburg virus disease treatment -
Middle East respiratory syndrome coronavirus treatment -
Yellow fever - -

Subjects

  • Subject Type volunteers
  • Number

    Planned: 88

    Actual: 94

  • Sex male & female
  • Age Group 18-50 years

Patient Inclusion Criteria

1. Weight ≥ 50 kg (110 lbs) and ≤ 100 kg (220 lbs) 2. Body mass index (BMI) of 19-32 kg/m2 3. Willing to abstain from alcohol consumption for a period of 2 days prior to and during the study 4. Sexually active women of child bearing potential and sexually active men must utilize 2 highly effective contraceptive methods 5. Abstain from caffeinated beverages 6. Normal vital signs at rest 7. Ability to provide written informed consent

Patient Exclusion Criteria

1. Subjects who are study site employees, or immediate family members of a study site or sponsor employee 2. Participation in a clinical research study within the previous 90 days 3. Any 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 4. Any screening laboratory test with an abnormal result that is grade 1 (mild) or greater 5. Abnormal ECG (defined as any screening or baseline QTc>450 msec, PR > 200 msec, or ventricular and/or atrial premature contractions that are more frequent than occasional, and/or as couplets or higher in grouping 6. An abnormal cardiovascular exam including a confirmed elevated blood pressure at screening (systolic greater than 140, diastolic greater than 90) after 5 minutes of supine rest, tachycardia >100 bpm after 5 minutes of supine rest 7. Family or personal history of sudden death or QT prolongation 8. Use of prescription, over-the-counter (OTC) medications or herbal supplements, with the exception of acetaminophen and non-oral hormonal contraception, for a period of 7 days prior to and during the study 9. Inadequate muscle mass to receive IM injections 10. History of alcohol or drug abuse within the previous year, or current evidence of substance dependence or abuse 11. Current smokers or history of smoking within the last 12 months 12. Serious adverse reaction or serious hypersensitivity to any drug 13. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active 14. Donation or loss of greater than 400 mL of blood within the previous 3 months 15. Positive serology for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) type 1 16. Pregnant or nursing females 17. Male subjects with pregnant female partners

Trial Details

Identifiers

Identifier Owner
NCT02319772 ClinicalTrials.gov: US National Institutes of Health
BCX4430-101 -
DMID14-0030 -

Organisations

  • Sponsors BioCryst Pharmaceuticals
  • Affiliations BioCryst Pharmaceuticals

Trial Dates

  • Initiation Dates

    Actual : 01 Dec 2014

  • Primary Completion Dates

    Planned : 01 Jun 2015

    Actual : 01 Mar 2016

  • End Dates

    Planned : 01 Aug 2015

    Actual : 05 May 2016

Other Details

  • Design double-blind; parallel; prospective; randomised
  • Phase of Trial Phase I
  • Location United Kingdom
  • Focus Adverse reactions; First in man

Interventions

Drugs Route Formulation
GalidesivirPrimary Drug Intramuscular Injection

BCX4430

Escalating doses of BCX4430 administered as an IM injection.
Drug: BCX4430

Placebo

Matched placebo administered as an IM injection.
Drug: Placebo

Results

Publications

  1. BioCryst Pharmaceuticals. BioCryst Completes Phase 1 Clinical Trial of Galidesivir . Media-Rel 2019;.

    Media Release

Authors

Author Total Publications First Author Last Author
BioCryst Pharmaceuticals 1 1 1

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Angela Rose
(+1) 919 226 5857
arose@biocryst.com
show details
-
Jo Collier, MBChB Quotient Clinical United-Kingdom
Sue Sweet
+44 (0)115 974 9000
show details
Quotient Clinical United-Kingdom

Centres

Centre Name Location Trial Centre Country
-
-
-
BioCryst Pharmaceuticals
-
-
National Institute of Allergy and Infectious Diseases (NIAID)
-
-
Quotient Clinical Ruddington United-Kingdom

Trial History

Event Date Event Type Comment
09 May 2019 Results Results presented in a BioCryst Pharmaceuticals media release. Updated 09 Aug 2019
11 Jul 2016 Other trial event Last checked against the ClinicalTrials.gov record. Updated 11 Jul 2016
05 May 2016 Status change - completed Status changed from recruiting to completed, as per BioCryst media release. Updated 12 May 2016
08 May 2015 Other trial event According to Biocryst media release, safety and pharmacokinetic/phamacodynamic results from this trial are expected in the third quarter of 2015. Updated 12 May 2015
08 May 2015 Other trial event According to Biocryst media release, this trial is funded by NIAID. Updated 12 May 2015
24 Dec 2014 New trial record New trial record Updated 24 Dec 2014
15 Dec 2014 Other trial event The first patient has been dosed, according to a BioCryst Pharmaceuticals media release Updated 26 Feb 2015

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  2. BioCryst Pharmaceuticals. BioCryst Completes Phase 1 Clinical Trial of Galidesivir . Media-Rel 2019;.

    Media Release
  3. BioCryst Pharmaceuticals. BioCryst Announces Initiation of a Phase 1 Clinical Trial of BCX4430 for the Treatment of Hemorrhagic Fever Viruses. Media-Rel 2014;.

    Media Release
  4. BioCryst Pharmaceuticals. BioCryst Reports Third Quarter 2014 Financial Results. Media-Rel 2014;.

    Media Release
  5. BioCryst Pharmaceuticals. BioCryst Reports First Quarter 2015 Financial Results. Media-Rel 2015;.

    Media Release
  6. BioCryst Pharmaceuticals. BioCryst Reports First Quarter 2016 Financial Results. Media-Rel 2016;.

    Media Release
  7. BioCryst Pharmaceuticals. BioCryst Reports Fourth Quarter & Full Year 2014 Financial Results. Media-Rel 2015;.

    Media Release
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