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
Latest Information Update: 09 Aug 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
- 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.
Most Recent Events
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
-
BioCryst Pharmaceuticals. BioCryst Completes Phase 1 Clinical Trial of Galidesivir . Media-Rel 2019;.
Media Release
Trial Centres
Investigators
Investigator | Centre Name | Trial Centre Country |
---|---|---|
Angela Rose
(+1) 919 226 5857
show details
arose@biocryst.com |
-
|
|
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 |
Table of Contents
References
-
ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov -
BioCryst Pharmaceuticals. BioCryst Completes Phase 1 Clinical Trial of Galidesivir . Media-Rel 2019;.
Media Release -
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 -
BioCryst Pharmaceuticals. BioCryst Reports Third Quarter 2014 Financial Results. Media-Rel 2014;.
Media Release -
BioCryst Pharmaceuticals. BioCryst Reports First Quarter 2015 Financial Results. Media-Rel 2015;.
Media Release -
BioCryst Pharmaceuticals. BioCryst Reports First Quarter 2016 Financial Results. Media-Rel 2016;.
Media Release -
BioCryst Pharmaceuticals. BioCryst Reports Fourth Quarter & Full Year 2014 Financial Results. Media-Rel 2015;.
Media Release
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