A Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and pharmacokinetics (PK) of escalating single dose of brincidofovir administered intravenously in healthy adult subjects
Phase 1
Recruiting
- Conditions
- AdenoviruscytomegalovirussmallpoxInfection - Other infectious diseases
- Registration Number
- ACTRN12616001657415
- Lead Sponsor
- Chimerix, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
non-child bearing potential
willing and able to provide written informed consent
non-tobacco/non-nicotine user in the past 6 months
body weight no greater than 50kg
BMI from 18-32 kg/m
no significant medical history
males cannot donate sperm during participation
Exclusion Criteria
child bearing potential
investigational drug or clinical study in the past 30 days
had any infection within the past 2 weeks
history of history chronic liver disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To investigate the safety and tolerability following single dose escalating doses of BCV administered IV in healthy adult subjects.<br><br>Clinical and laboratory safety parameters including: adverse events (AE's), absolute and changes over time of hematology, clinical chemistry, urinalysis, vital signs, and ECG intervals<br>[Adverse Events (AEs), vital signs, clinical and laboratory safety assessments: At Screening Day -28, Days -1, 1, 2, 3, 4, 5, 8, 10, and Follow Up Day 14<br><br>Hematology, serum chemistry, urinalysis Screening Day -28, Days -1, 3, 5, 8, and Follow Up Day 14<br><br>ECG Assessments: On Day 1: pre-dose (within 15 minutes prior to start of infusion), 2 (end of infusion), 3, 4, 6, 8, 10, 12, 14, 16, and 24 hours post start of infusion. ]
- Secondary Outcome Measures
Name Time Method To characterize plasma BCV and CDV PK, and intracellular (peripheral blood mononuclear cells {PBMCs}) BCV and CDV-PP PK following single escalating doses of BCV administered IV in healthy adult subjects<br><br>Plasma BCV and CDV Cmax, Tmax, AUClast, AUCinf, %AUCextrap, Clast, Tlast, t1/2, CL (BCV only), Vss (BCV only)[Blood will be collected for determination of plasma BCV and CDV concentrations during each period as follows:<br>Subjects receiving BCV IV: pre-dose (within 15 minutes prior to start of infusion) and at 2 (end of infusion), 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96, and 168 hours post start of infusion.<br>]