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

BioCryst Pharmaceuticals32 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Marburg Virus Disease

Interventions

galidesivirDRUG

galidesivir IV infusion

placeboDRUG

placebo IV infusion

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

PRA Health Sciences

Lenexa, Kansas, United States

Outcomes

Primary Outcomes

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).

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 Outcomes

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.).

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

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.).

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

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.

Data from ClinicalTrials.gov

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