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A Study of AK0529 in Infants Hospitalized With RSV
This study has been terminated.
(We switched this study design to another study per IEC's recommendations.)
Sponsor:
Ark Biosciences Inc.
Information provided by (Responsible Party):
Ark Biosciences Inc.
ClinicalTrials.gov Identifier:
NCT02460016
First received: May 27, 2015
Last updated: June 28, 2016
Last verified: June 2016
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Purpose
This study will assess the safety, tolerability, pharmacokinetics (PK) and anti-viral effect of single dose of AK0529 in infants hospitalized with respiratory syncytial virus (RSV).
| Condition | Intervention | Phase |
|---|---|---|
| Respiratory Syncytial Virus Infections | Drug: AK0529 | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1b, Open-label, Multicenter, Single Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of AK0529 in Infants Hospitalized With Respiratory Syncytial Virus Infection |
Resource links provided by NLM:
Further study details as provided by Ark Biosciences Inc.:
Primary Outcome Measures:
- Number of Adverse Events [ Time Frame: Baseline through 7 days post administration ]
Secondary Outcome Measures:
- Pharmacokinetics parameters, including maximum and minimum of drug concentration [ Time Frame: Baseline through 3 days post administration ]
- Pharmacokinetics parameters, including time to maximum concentration and half-time [ Time Frame: Baseline through 3 days post administration ]
- Pharmacokinetics parameters, including area under concentration-time curves (AUC) [ Time Frame: Baseline through 3 days post administration ]
| Enrollment: | 1 |
| Study Start Date: | September 2015 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: AK0529
AK0529 pellets
|
Drug: AK0529
AK0529 pellets for oral administration
Other Name: AK0529 pellets
|
Detailed Description:
This is a open-label Phase 1b study to evaluate the safety, tolerability, pharmacodynamics and Pharmacokinetics of AK0529 in hospitalized RSV infected infants age from 1 to 24 months.
Eligibility| Ages Eligible for Study: | 1 Month to 24 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female subjects of any race or ethnicity with an age adjusted for any prematurity of ≥1 month and ≤24 months.
- Diagnosis of RSV infection by virological.
- Subject must weigh >3 kg at screening.
- Must have provided written informed consent for the subject to participate.
- For patients aged <12 months, and occipitofrontal head circumference (OFHC) within the normal range for age and gender.
Exclusion Criteria:
- The subject has taken, is currently taking or requires any restricted medications.
- Subject is known to be HIV-positive (or the mother, if the potential subject is a child aged <6 months).
- Participation in an investigational drug or device study within 30 days prior to the date of screening.
- Requires vasopressors or inotropic support at the time of enrollment.
- Concurrent gastrointestinal conditions that could, in the opinion of the investigator, prejudice absorption of the Investigational Medicinal Product (e.g. protracted vomiting, malabsorption syndrome, a history of necrotising enterocolitis with consequent short gut syndrome).
- Bronchopulmonary dysplasia or chronic lung disease requiring assisted ventilation at the time of enrollment.
- Diminished ventilatory reserve at risk for hypercapnia (e.g. pulmonary hypoplasia, sequestration syndromes, cystadenomatoid malformation, a history of surgery for diaphragmatic hernia).
- Left to right shunt meriting corrective therapy.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02460016
Please refer to this study by its ClinicalTrials.gov identifier: NCT02460016
Locations
| Australia, South Australia | |
| Women's & Children's Hospital | |
| Adelaide, South Australia, Australia | |
Sponsors and Collaborators
Ark Biosciences Inc.
Investigators
| Study Director: | Stephen Toovey, MD PhD | Ark Biosciences Inc. |
More Information
| Responsible Party: | Ark Biosciences Inc. |
| ClinicalTrials.gov Identifier: | NCT02460016 History of Changes |
| Other Study ID Numbers: |
AK0529-1002 |
| Study First Received: | May 27, 2015 |
| Last Updated: | June 28, 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Additional relevant MeSH terms:
|
Infection Virus Diseases Respiratory Syncytial Virus Infections Pneumovirus Infections |
Paramyxoviridae Infections Mononegavirales Infections RNA Virus Infections |
ClinicalTrials.gov processed this record on July 14, 2017