Back to results

A Study to Evaluate the Single Dose Safety, Tolerability and Pharmacokinetics of IV BCX4430

Primary Purpose

Marburg Virus Disease

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

galidesivir

placebo

About this trial

This is an interventional treatment trial for Marburg Virus Disease

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Key Inclusion Criteria:

written informed consent
males and non-pregnant, non-lactating females
BMI 19.0-32.0
willing to abide by contraceptive requirements
normal vitals
willing to abide by study procedures and restrictions

Exclusion Criteria:

clinically significant medical condition or medical history or psychiatric condition or history of psychiatric condition
abnormal cardiac finding, or laboratory/urinalysis abnormality at screening
known family history of sudden death or long QT syndrome, family or personal history of QT prolongation, or arrhythmia that required medical intervention
current participation in any other investigational drug study or participation in an investigational drug study within 3 months of screening visit
use of prescription, OTC, or herbal medications during study or use of any specified medications within 30 days prior to study
Recent or current history of alcohol or drug abuse
Regular use of tobacco or nicotine products
Positive serology for HBV, HCV, or HIV
history of severe adverse reaction to or known sensitivity to any drug
pregnant, lactating, or planning to become pregnant within 30 days of the study. Male subjects with pregnant female partners are excluded

Sites / Locations

PRA Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Galidesivir

placebo

Arm Description

Galidesivir IV infusion

Placebo IV infusion

Outcomes

Primary Outcome Measures

Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events.

Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE).

Secondary Outcome Measures

Plasma PK - Galidesivir Cmax (Maximum Observed Concentration of Drug)

Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points: Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose. Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day) Day 21 (+2 days) or early termination. Cmax for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.).

Plasma PK - Galidesivir AUC (Area Under the Concentration vs. Time Curve)

Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points: Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose. Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day) Day 21 (+2 days) or early termination. AUC0-inf (AUC from time 0 extrapolated to infinite time) and AUC0-t (AUC from time 0 to time t, where "t" = the last quantifiable concentration) for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.).

Galidesivir Renal Clearance

Urine was collected from subjects over a 96 hour period per protocol, analyzed for galidesivir concentrations. Urine PK parameters including CLR (renal clearance of unchanged drug cumulatively over all collection intervals or in a specific interval) were estimated in SAS for Windows v9.4 or higher (SAS Institute, Inc.) based on the recorded urine concentrations and volumes.

Full Information

NCT ID

NCT03800173

First Posted

December 12, 2018

Last Updated

July 2, 2021

Sponsor

BioCryst Pharmaceuticals

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

1. Study Identification

Unique Protocol Identification Number

NCT03800173

Brief Title

A Study to Evaluate the Single Dose Safety, Tolerability and Pharmacokinetics of IV BCX4430

Official Title

A Phase 1 Double-blind, Placebo Controlled, Dose Ranging Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Galidesivir (BCX4430) Administered as Single Doses Via Intravenous Infusion in Healthy Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

December 10, 2018 (Actual)

Primary Completion Date

April 30, 2019 (Actual)

Study Completion Date

April 30, 2019 (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

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a placebo-controlled, randomized, double-blind study to evaluate the pharmacokinetics of galidesivir following administration of single doses by IV infusion

Detailed Description

This single ascending dose study will evaluate the safety, tolerability, and PK of single doses of galidesivir vs. placebo administered as IV infusions in healthy subjects enrolled in up to four dose cohorts of 8 subjects each. A single dose of study drug will be administered per cohort: 6 subjects will receive galidesivir IV, and 2 subjects will receive matching placebo.

6. Conditions and Keywords

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

Marburg Virus Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Galidesivir

Arm Type

Experimental

Arm Description

Galidesivir IV infusion

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

Placebo IV infusion

Intervention Type

Drug

Intervention Name(s)

galidesivir

Intervention Description

galidesivir IV infusion

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

placebo IV infusion

Primary Outcome Measure Information:

Title

Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events.

Description

Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE).

Time Frame

AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up period, up to 23 days from IMP dosing on Day 1.

Secondary Outcome Measure Information:

Title

Plasma PK - Galidesivir Cmax (Maximum Observed Concentration of Drug)

Description

Time Frame

Plasma PK parameters are based on sampling over a 21 day period

Title

Plasma PK - Galidesivir AUC (Area Under the Concentration vs. Time Curve)

Description

Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points: Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose. Day 6 (+1 day), Day 8 (+1 day), Day 14 (± 1 day) Day 21 (+2 days) or early termination. AUC0-inf (AUC from time 0 extrapolated to infinite time) and AUC0-t (AUC from time 0 to time t, where "t" = the last quantifiable concentration) for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.).

Time Frame

Plasma PK parameters are based on sampling over a 21 day period

Title

Galidesivir Renal Clearance

Description

Time Frame

Urine PK parameters are based on sampling over a 96 hour period.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: written informed consent males and non-pregnant, non-lactating females BMI 19.0-32.0 willing to abide by contraceptive requirements normal vitals willing to abide by study procedures and restrictions Exclusion Criteria: clinically significant medical condition or medical history or psychiatric condition or history of psychiatric condition abnormal cardiac finding, or laboratory/urinalysis abnormality at screening known family history of sudden death or long QT syndrome, family or personal history of QT prolongation, or arrhythmia that required medical intervention current participation in any other investigational drug study or participation in an investigational drug study within 3 months of screening visit use of prescription, OTC, or herbal medications during study or use of any specified medications within 30 days prior to study Recent or current history of alcohol or drug abuse Regular use of tobacco or nicotine products Positive serology for HBV, HCV, or HIV history of severe adverse reaction to or known sensitivity to any drug pregnant, lactating, or planning to become pregnant within 30 days of the study. Male subjects with pregnant female partners are excluded

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel Dickerson, MD, PhD

Organizational Affiliation

PRA Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

PRA Health Sciences

City

Lenexa

State/Province

Kansas

ZIP/Postal Code

66219

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

Learn more about this trial

A Study to Evaluate the Single Dose Safety, Tolerability and Pharmacokinetics of IV BCX4430

We'll reach out to this number within 24 hrs