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

Primary Purpose

Filovirus Infections, Ebola Virus Infection

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

BCX4430

Placebo

About this trial

This is an interventional treatment trial for Filovirus Infections focused on measuring Healthy volunteers, Ebola virus, Filovirus

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Subjects who are study site employees, or immediate family members of a study site or sponsor employee
Participation in a clinical research study within the previous 90 days
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
Any screening laboratory test with an abnormal result that is grade 1 (mild) or greater
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
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
Family or personal history of sudden death or QT prolongation
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
Inadequate muscle mass to receive IM injections
History of alcohol or drug abuse within the previous year, or current evidence of substance dependence or abuse
Current smokers or history of smoking within the last 12 months
Serious adverse reaction or serious hypersensitivity to any drug
Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active
Donation or loss of greater than 400 mL of blood within the previous 3 months
Positive serology for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) type 1
Pregnant or nursing females
Male subjects with pregnant female partners

Sites / Locations

Quotient Clinical

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BCX4430

Placebo

Arm Description

BCX4430 administered as an IM injection

Matched placebo administered as an IM injection

Outcomes

Primary Outcome Measures

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

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

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

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

Full Information

NCT ID

NCT02319772

First Posted

December 11, 2014

Last Updated

July 6, 2016

Sponsor

BioCryst Pharmaceuticals

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

1. Study Identification

Unique Protocol Identification Number

NCT02319772

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

December 2014 (undefined)

Primary Completion Date

March 2016 (Actual)

Study Completion Date

April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

BioCryst Pharmaceuticals

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Filovirus Infections, Ebola Virus Infection

Keywords

Healthy volunteers, Ebola virus, Filovirus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

94 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BCX4430

Arm Type

Experimental

Arm Description

BCX4430 administered as an IM injection

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Matched placebo administered as an IM injection

Intervention Type

Drug

Intervention Name(s)

BCX4430

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

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

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

Secondary Outcome Measure Information:

Title

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

Title

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 Pre-specified Outcome Measures:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Weight ≥ 50 kg (110 lbs) and ≤ 100 kg (220 lbs) Body mass index (BMI) of 19-32 kg/m2 Willing to abstain from alcohol consumption for a period of 2 days prior to and during the study Sexually active women of child bearing potential and sexually active men must utilize 2 highly effective contraceptive methods Abstain from caffeinated beverages Normal vital signs at rest Ability to provide written informed consent Exclusion Criteria: Subjects who are study site employees, or immediate family members of a study site or sponsor employee Participation in a clinical research study within the previous 90 days 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 Any screening laboratory test with an abnormal result that is grade 1 (mild) or greater 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 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 Family or personal history of sudden death or QT prolongation 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 Inadequate muscle mass to receive IM injections History of alcohol or drug abuse within the previous year, or current evidence of substance dependence or abuse Current smokers or history of smoking within the last 12 months Serious adverse reaction or serious hypersensitivity to any drug Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active Donation or loss of greater than 400 mL of blood within the previous 3 months Positive serology for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) type 1 Pregnant or nursing females Male subjects with pregnant female partners

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jo Collier, MBChB

Organizational Affiliation

Quotient Clinical

Official's Role

Principal Investigator

Facility Information:

Facility Name

Quotient Clinical

City

Ruddington

ZIP/Postal Code

NG11 6JS

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

35182042

Citation

Mathis A, Collins D, Dobo S, Walling DM, Sheridan WP, Taylor R. Pharmacokinetics and Safety of the Nucleoside Analog Antiviral Drug Galidesivir Administered to Healthy Adult Subjects. Clin Pharmacol Drug Dev. 2022 Apr;11(4):467-474. doi: 10.1002/cpdd.1037. Epub 2022 Feb 19.

Results Reference

derived

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

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