A Study of AK0529 in Infants Hospitalized With RSV

Respiratory Syncytial Virus Infections Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02460016
• Other study ID #: AK0529-1002
• Status: Terminated
• Phase: Phase 1
• Start date: August 28, 2015
• Est. completion date: November 3, 2015

Study information

• Verified date: June 2018
• Source: Ark Biosciences Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: November 3, 2015
• Est. primary completion date: November 3, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 24 Months

Eligibility

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.

Related Conditions & MeSH terms

• Infection
• Respiratory Syncytial Virus Infections
• Virus Diseases

Intervention

Drug:
• AK0529
AK0529 pellets for oral administration

Locations

Country	Name	City	State
Australia	Women's & Children's Hospital	Adelaide	South Australia

Sponsors (1)

Lead Sponsor	Collaborator
Ark Biosciences Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Events		Baseline through 7 days post administration
Secondary	Pharmacokinetics parameters, including maximum and minimum of drug concentration		Baseline through 3 days post administration
Secondary	Pharmacokinetics parameters, including time to maximum concentration and half-time		Baseline through 3 days post administration
Secondary	Pharmacokinetics parameters, including area under concentration-time curves (AUC)		Baseline through 3 days post administration