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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-10

Study Completion Date

2019-04-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Marburg Virus Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Galidesivir

Galidesivir IV infusion

Group Type EXPERIMENTAL

galidesivir

Intervention Type DRUG

galidesivir IV infusion

placebo

Placebo IV infusion

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo IV infusion

Interventions

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galidesivir

galidesivir IV infusion

Intervention Type DRUG

placebo

placebo IV infusion

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes