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A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BCX4430

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ClinicalTrials.gov Identifier: NCT02319772
Recruitment Status : Completed
First Posted : December 18, 2014
Last Update Posted : July 7, 2016
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
BioCryst Pharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Filovirus Infections Ebola Virus Infection Drug: BCX4430 Drug: Placebo Phase 1

Detailed Description:

Part 1 of the study will evaluate the safety, tolerability and pharmacokinetics of single, ascending doses of BCX4430 versus placebo in healthy subjects. Up to 6 ascending dose cohorts will be enrolled in a sequential manner. Eight subjects will be treated with a single dose of study drug per dose cohort: 6 subjects per cohort will receive BCX4430, and 2 subjects per cohort will receive matching placebo.

Part 2 of the study will be initiated following review of all available data from Part 1 by an independent Safety Monitoring Committee

Part 2 of the study will evaluate the safety, tolerability, and pharmacokinetics of 7 days of daily dosing with BCX4430 versus placebo in healthy subjects. Up to 4 ascending dose cohorts will be treated in a sequential manner. Ten subjects will be treated with study drug per dose cohort (8 subjects will receive BCX4430 and 2 subjects will receive placebo per cohort). The planned doses and dosing regimens for each of the Part 2 cohorts will be determined based upon data collected during Part 1.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ebola

Arm Intervention/treatment
Experimental: BCX4430
BCX4430 administered as an IM injection
Drug: BCX4430
Placebo Comparator: Placebo
Matched placebo administered as an IM injection
Drug: Placebo



Primary Outcome Measures :
  1. 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 [ Time Frame: Part 1: 7 days. Part 2: 14 days ]
    Evaluation of the incidence and severity of adverse events, laboratory abnormalities, ECG findings, vital sign changes, injection site and physical examination findings


Secondary Outcome Measures :
  1. Plasma exposure of BCX4430, determined by the concentration time profile and PK parameters following single (Part 1) and multiple (Part 2) doses of BCX4430 [ Time Frame: Part 1: 7 days. Part 2: 14 days ]
  2. The urinary elimination of BCX4430, determined by the concentration of drug following single (Part 1) and multiple (Part 2) doses of BCX4430 [ Time Frame: Part 1: 7 days. Part 2: 14 days ]

Other Outcome Measures:
  1. 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 [ Time Frame: Part 1: 7 days. Part 2: 14 days ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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

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): NCT02319772


Locations
United Kingdom
Quotient Clinical
Ruddington, United Kingdom, NG11 6JS
Sponsors and Collaborators
BioCryst Pharmaceuticals
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Jo Collier, MBChB Quotient Clinical

Responsible Party: BioCryst Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02319772     History of Changes
Other Study ID Numbers: BCX4430-101
DMID 14-0030 ( Other Identifier: NIAID/ Division of Microbiology and Infectious Diseases )
First Posted: December 18, 2014    Key Record Dates
Last Update Posted: July 7, 2016
Last Verified: July 2016

Keywords provided by BioCryst Pharmaceuticals:
Healthy volunteers
Ebola virus
Filovirus

Additional relevant MeSH terms:
Infection
Communicable Diseases
Virus Diseases
Hemorrhagic Fever, Ebola
Hemorrhagic Fevers, Viral
RNA Virus Infections
Filoviridae Infections
Mononegavirales Infections