Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001657415
Ethics application status
Approved
Date submitted
29/11/2016
Date registered
1/12/2016
Date last updated
1/12/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 290609 0
None
Universal Trial Number (UTN)
U1111-1190-0073
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adenovirus 301098 0
cytomegalovirus 301100 0
smallpox 301179 0
Condition category
Condition code
Infection 300871 300871 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
4 cohorts
Intravenous (IV) brincidofovir (BCV) 10mg or IV Placebo, single dose-6 active and 2 placebo
IV BCV 25mg or IV Placebo, single dose-6 active and 2 placebo
IV BCV 50mg or IV Placebo, single dose-9 active and 3 placebo
IV BCV 100mg or IV Placebo, single dose-9 active and 3 placebo

Dose escalation will be based on safety, tolerability, and pharmacokinetics of each cohort. A safety and PK review by the Chimerix Study Team and the Principal Investigator (PI) will occur prior to escalation to the next dose level.
Intervention code [1] 296472 0
Treatment: Drugs
Comparator / control treatment
IV Placebo D5W Solution, single dose
Control group
Placebo

Outcomes
Primary outcome [1] 300279 0
To investigate the safety and tolerability following single dose escalating doses of BCV administered IV in healthy adult subjects.

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
Timepoint [1] 300279 0
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

Hematology, serum chemistry, urinalysis Screening Day -28, Days -1, 3, 5, 8, and Follow Up Day 14

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 [1] 329598 0
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

Plasma BCV and CDV Cmax, Tmax, AUClast, AUCinf, %AUCextrap, Clast, Tlast, t1/2, CL (BCV only), Vss (BCV only)
Timepoint [1] 329598 0
Blood will be collected for determination of plasma BCV and CDV concentrations during each period as follows:
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.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
29/11/2016
Date of last participant enrolment
Anticipated
17/03/2017
Actual
Date of last data collection
Anticipated
15/06/2017
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 8420 0
New Zealand
State/province [1] 8420 0

Funding & Sponsors
Funding source category [1] 295071 0
Commercial sector/Industry
Name [1] 295071 0
Chimerix, Inc
Country [1] 295071 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Chimerix, Inc
Address
2505 Meridian Parkway
Suite 100
Durham, NC 27713
USA
Country
United States of America
Secondary sponsor category [1] 293881 0
None
Name [1] 293881 0
Address [1] 293881 0
Country [1] 293881 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296415 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 296415 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 296415 0
New Zealand
Date submitted for ethics approval [1] 296415 0
Approval date [1] 296415 0
17/11/2016
Ethics approval number [1] 296415 0

Summary
Brief summary
This is the first clinical study administering a new intravenous formulation of BCV. BCV has been studied in hundreds of patients as an oral formulation for the treatment of adenovirus and for the treatment and prevention of cytomegalovirus following stem cell transplantation. This first IV BCV study will investigate the safety and tolerability following single escalating doses to healthy subjects to observe how the new formulation compares to the oral formulations.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70706 0
Dr Christopher J. Wynne
Address 70706 0
Christchurch Clinical Studies Trust Ltd
31 Tuam Street
Christchurch 8011
Country 70706 0
New Zealand
Phone 70706 0
+ 64 3 372 9477
Fax 70706 0
Email 70706 0
mark@ccst.co.nz
Contact person for public queries
Name 70707 0
Mr Mark Warner
Address 70707 0
Christchurch Clinical Studies Trust Ltd
31 Tuam Street
Christchurch 8011
Country 70707 0
New Zealand
Phone 70707 0
+ 64 3 372 9477
Fax 70707 0
Email 70707 0
mark@ccst.co.nz
Contact person for scientific queries
Name 70708 0
Mrs Maggie Anderson
Address 70708 0
2505 Meridian Parkway
Suite 100
Durham NC 27713
USA
Country 70708 0
United States of America
Phone 70708 0
+ 1 919-313 2971
Fax 70708 0
Email 70708 0
manderson@chimerix.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseRecent Advances in Research and Management of Human Monkeypox Virus: An Emerging Global Health Threat.2023https://dx.doi.org/10.3390/v15040937
Dimensions AIAn opportunity for evidence-based care of individuals with monkeypox2022https://doi.org/10.1136/bmjebm-2022-112086
N.B. These documents automatically identified may not have been verified by the study sponsor.