Safety & Pharmacokinetics Study of Inhaled Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Children With Influenza

NCT ID: NCT02014649

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-05-31

Brief Summary

This Phase 1/2 protocol is designed to collect safety, tolerability and pharmacokinetic data of two doses of Laninamivir Octanoate in children and adolescents. The protocol will also explore virology and efficacy endpoints.

Detailed Description

Approximately 48 subjects aged 5-17 years inclusive will be randomised into the study.

Subjects with recent onset of presumptive influenza will have influenza A or B infection confirm by Rapid Antigen Test.

The study will be conducted on an outpatient basis. The dose is administered in a single session in the clinic on Day 1. The subject will return to the clinic for assessments and follow up.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

20mg Laninamivir Octanoate

Dry Powder plus placebo

Group Type: EXPERIMENTAL

20 mg laninamivir octanoate

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

40mg Laninamivir Octanoate

Dry Powder

Group Type: EXPERIMENTAL

40 mg laninamivir octanoate

Intervention Type: DRUG

Interventions

20 mg laninamivir octanoate

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

40 mg laninamivir octanoate

Intervention Type: DRUG

Other Intervention Names

CS-8958; Lactose; CS-8958

Eligibility Criteria

Inclusion Criteria

• Subjects' parent/legally acceptable representative/guardian must give written informed consent to participate in the study and must understand the nature of the study and must be willing to comply with all protocol requirements. Subjects over 12 must provide assent to participate in the study and potential subjects below this age should provide assent if deemed appropriate to the maturity level of the subject or if required according to local guidance/regulations.
• Males or females aged between 5 and 17 years inclusive, who weigh at least 15 kg at screening.
• Confirmed influenza infection based on positive rapid antigen test (RAT) for Influenza A or B.
• Fever, defined as either:

1. Otic temperature ≥38.0° C (100.4°F) at the screening visit, OR,

2. A history of fever within the 24 hours prior to the screening visit and has administered antipyretic(s) in the 6 hours prior to the screening visit.

• Presence on the Screening questionnaire of, at least two, of the following influenza symptoms:

1. Non-productive Cough, of at least moderate severity,

2. Sore throat, of at least moderate severity,

3. Nasal congestion/runny nose, of at least moderate severity,

4. Headache, of at least moderate severity,

5. Muscle aches and pain, of at least moderate severity,

6. Feeling feverish, of at least moderate severity,

7. Low energy, tired, fatigue, of at least moderate severity;

• Onset of illness no more than 40 hours before randomization, defined as:

1. time when the temperature was first measured as elevated ≥38.0°C (oral or otic) OR

2. time when the subject first experienced at least one influenza symptom (non-productive cough, sore throat or nasal congestion/runny nose, headache, muscle aches and pain, feeling feverish, or low energy/tired/fatigue)

• In the Investigator's opinion able to complete the required inhalations of the investigational medicinal product.

Exclusion Criteria

• Use of antiviral treatment for influenza (e.g., zanamivir, oseltamivir, peramivir, rimantadine, or amantadine) within 14 days prior to screening
• Received influenza virus vaccine in the previous 3 weeks.
• History or presence of clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease, cystic fibrosis, or bronchiectasis)
• Current asthma requiring treatment, or history of asthma requiring treatment in the last 5 years, or episode of wheezing in the 12 months prior to randomization.
• History of congestive heart failure with symptoms consistent with New York Heart Association Class III or IV functional status.
• Presence of an immune compromised status due to chronic illness, organ transplantation or use of daily systemic immunosuppressants
• Presence of clinically significant signs of acute respiratory distress during screening.
• Current use of inhaled medications (nasal or oral) or anticipated use of inhaled medications (nasal or oral) at any time during the study.
• Current or a history of acute or chronic renal impairment/disease
• Currently hospitalized or any planned hospitalizations within 1 month following the last dose of IMP.
• Current clinical evidence of otitis, bronchitis, sinusitis, or pneumonia or active bacterial infection at any body site
• Severe infection within 30 days prior to screening which required parenteral antibiotic use or hospitalization.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Department of Health and Human Services

FED

Sponsor Role: collaborator

Biota Scientific Management Pty Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jolanta Airey, Dr

Role: STUDY_DIRECTOR

Biota Scientific Management Pty Ltd

Locations

Precision Trials LLC

Phoenix, Arizona, United States

Arkansas Children's Hospital

Little Rock, Arkansas, United States

SoCal Clinical Research Med Group

Bellflower, California, United States

Sherif Khamis MD Inc

Canoga Park, California, United States

Advanced Medical Research

Lakewood, California, United States

Madera Family Medical Group

Madera, California, United States

Connecticut Children's Medical Center

Hartford, Connecticut, United States

A.G.A Clinical Trials

Hialeah, Florida, United States

Lafayette Clinical Research Group

Lafayette, Indiana, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Louisiana State University Health Sciences Center

Shreveport, Louisiana, United States

Dr Haidar's Clinic

Carriere, Mississippi, United States

DePaul Health Center

Bridgeton, Missouri, United States

Blue Ridge Pediatric and Adolescent Medicine Group

Boone, North Carolina, United States

Dayton Children's Hospital

Dayton, Ohio, United States

The University of Toledo Medical Center

Toledo, Ohio, United States

Dr Santiago Reyes

Oklahoma City, Oklahoma, United States

Cyn3rgy Research

Gresham, Oregon, United States

Sanford Research University of South Dakota

Sioux Falls, South Dakota, United States

Avant Research Assoc.

Houston, Texas, United States

West Houston Clinical Research Service

Houston, Texas, United States

Foothill Family Clinic

Salt Lake City, Utah, United States

First Med

Salt Lake City, Utah, United States

Foothill Family Clinic South

Salt Lake City, Utah, United States

Copperview Medical Center

South Jordan, Utah, United States

Dixie Pediatrics

St. George, Utah, United States

Rockwood Clinic

Spokane, Washington, United States

Rockwood North Clinic

Spokane, Washington, United States

Countries

United States

Other Identifiers

U1111-1150-7392

Identifier Type: OTHER

Identifier Source: secondary_id

BTA51-350-203

Identifier Type: -

Identifier Source: org_study_id