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

NCT02319772 | Completed Phase 1 DMC

• 2 other identifiers: BCX4430-101DMID 14-0030
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Filovirus Infections; Ebola Virus Infection

Keywords

Healthy volunteers; Ebola virus; Filovirus

Outcome Measures

Primary Outcomes (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

  Evaluation of the incidence and severity of adverse events, laboratory abnormalities, ECG findings, vital sign changes, injection site and physical examination findings

  Part 1: 7 days. Part 2: 14 days

Secondary Outcomes (2)

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

  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

  Part 1: 7 days. Part 2: 14 days

Other Outcomes (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

  Part 1: 7 days. Part 2: 14 days

Study Arms (2)

BCX4430

EXPERIMENTAL

BCX4430 administered as an IM injection

Drug: BCX4430

Placebo

PLACEBO COMPARATOR

Matched placebo administered as an IM injection

Drug: Placebo

Interventions

BCX4430 DRUG

BCX4430

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BioCryst Pharmaceuticals: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Quotient Clinical

Ruddington, NG11 6JS, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 35182042 DERIVED

MeSH Terms

Conditions

Filoviridae Infections; Hemorrhagic Fever, Ebola

Interventions

galidesivir

Condition Hierarchy (Ancestors)

Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections; Hemorrhagic Fevers, Viral

Study Officials

• Jo Collier, MBChB

  Quotient Clinical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2014
• First Posted: December 18, 2014
• Study Start: December 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: April 1, 2016
• Last Updated: July 7, 2016

Record last verified: 2016-07

Locations

GB (1)