Marburg Virus DiseasePhase 1NCT03800173
A Study to Evaluate the Single Dose Safety, Tolerability and Pharmacokinetics of IV BCX4430
A Phase 1 study testing galidesivir in people with Marburg Virus Disease, run by BioCryst Pharmaceuticals at 1 site in United States.
Trial summary
This is a placebo-controlled, randomized, double-blind study to evaluate the pharmacokinetics of galidesivir following administration of single doses by IV infusion Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Marburg Virus Disease
- What is being tested?
- galidesivir
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2018to 30 Apr 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
This is a placebo-controlled, randomized, double-blind study to evaluate the pharmacokinetics of galidesivir following administration of single doses by IV infusion
Read the 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.
- Conditions
- Marburg Virus Disease
- Being tested
- galidesivir, placebo
- Medical subject headings
- Marburg Virus Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
galidesivirDrug
galidesivir IV infusion
placeboDrug
placebo IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Galidesivir | Experimental | Galidesivir IV infusion Receives: Drug: galidesivir |
| placebo | Placebo comparator | Placebo IV infusion Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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 (3)
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.).
Measured: 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.).
Measured: 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.
Measured: Urine PK parameters are based on sampling over a 96 hour period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start10 Dec 2018
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Marburg Virus DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioCryst Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Dickerson, MD, PhD, Principal investigator, PRA Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03800173
- Sponsor's protocol ID
- BCX4430-106
- Other IDs
- DMID18-0013, 272201300017C-18-0-1
- Status last verified
- Jul 2021
- First submitted
- 12 Dec 2018
- Last updated
- 23 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35182042
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03800173
- Acronym / sponsor ID
- BCX4430-106
- Conditions
- Marburg Virus Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- BioCryst PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 11 Jan 2019 (actual)
- Results
- Posted 23 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Galidesivir | Experimental | Drug: galidesivirGalidesivir IV infusion |
| placebo | Placebo comparator | Drug: placeboPlacebo IV infusion |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- written informed consent
- males and non-pregnant, non-lactating females
- BMI 19.0-32.0
- willing to abide by contraceptive requirements
- normal vitals
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| galidesivirgalidesivir IV infusion | Drug | Galidesivir |
| placeboplacebo IV infusion | Drug | placebo |
Primary outcome
Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events.
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.
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).
3 secondary outcomes
Plasma PK - Galidesivir Cmax (Maximum Observed Concentration of Drug)
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)
Time frame: Plasma PK parameters are based on sampling over a 21 day period
Galidesivir Renal Clearance
Time frame: Urine PK parameters are based on sampling over a 96 hour period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35182042Mathis 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.
- Individual participant dataSharing planned: No
Related trials for Marburg Virus Disease
Active, not recruitingPhase 1
A Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-MARV-GP Vaccine in Adults in Good General Health
Marburg Virus Disease
Active, not recruitingPhase 2
A Trial to Evaluate Safety, Tolerability, and Immune Responses of an Investigational Monovalent Chimpanzee Adenoviral Vectored Marburg Virus Vaccine in Healthy Adults
Marburg Virus Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Dickerson, MD, PhD principal investigator
PRA Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing galidesivir in people with Marburg Virus Disease, run by BioCryst Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03800173, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2021.