Safety, Tolerability and Pharmacokinetics of Inhaled Laninamivir Octanoate TwinCaps® DPI in Adults With Chronic Asthma

NCT02022761 | Completed Phase 1

• 1 other identifier: BTA51-350-101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single centre, randomized, double-blind, placebo-controlled, single ascending dose study, in which the safety and pharmacokinetics of laninamivir octanoate administered by inhalation via the TwinCaps® DPI will be assessed in adults with mild or moderate chronic asthma.

Conditions

Asthma

Keywords

Mild or moderate asthmatics; Adults; Laninamivir

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety and tolerability of single ascending doses (40 mg and 80 mg) of laninamivir octanoate administered by inhalation via the TwinCaps® DPI in adults with mild or moderate chronic asthma.

  Safety and tolerability data will be presented according to the dose group and asthma Strata. All safety data will be summarized with descriptive statistics and included assessments of SAEs, AEs, Laboratory Results, Vital Signs, ECGs, Spirometry parameters, Con Meds, Physical Exam findings

  Subjects assessed at clinic visits and up to 14 days post-dose

Secondary Outcomes (1)

• To evaluate the pharmacokinetics of laninamivir octanoate and its active metabolite laninamivir following administration of 40 mg & 80 mg doses of laninamivir octanoate by inhalation via the TwinCaps® DPI in adults with mild or moderate chronic a

  Samples are collected up to 144 hours post-dose

Study Arms (3)

40 mg Laninamivir octanoate

EXPERIMENTAL

Dry Powder Inhaler

Drug: Laninamivir octanoate

80 mg Laninamivir octanoate

EXPERIMENTAL

Dry Powder Inhaler

Drug: Laninamivir octanoate

Matching placebo

PLACEBO COMPARATOR

Dry Powder Inhaler

Drug: Laninamivir octanoate

Interventions

Laninamivir octanoate DRUG

40 mg dose consists of 2 laninamivir octanoate TwinCaps® DPI 80 mg dose consists of 4 laninamivir octanoate TwinCaps® DPI (2 administered 12 hours apart)

Also known as: CS-8958

40 mg Laninamivir octanoate; 80 mg Laninamivir octanoate; Matching placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male or female subjects 18 to 65 years of age, inclusive
• Body mass index (BMI) within the range of 19.0 to 33.0 kg/m2, inclusive at screening
• Minimum weight of 55.0 kg at screening and pre-dose Day 1
• Clinical diagnosis of asthma by a physician for ≥12 months prior to screening confirmed in writing and/or by medical records
• Mild asthmatics currently requiring treatment with low dose inhaled corticosteroids or other low intensity treatment OR Moderate asthmatics, requiring treatment with low dose inhaled corticosteroids and long-acting beta agonists, medium- high dose inhaled corticosteroids alone or low dose inhaled corticosteroids and other low intensity treatment8
• Well controlled asthma for 1 month prior to dosing defined by the following:
• Daytime symptoms occur ≤8 times/ 4 weeks
• Daily activity is not limited by asthma
• No nocturnal symptoms resulting in nighttime awakenings
• Use of short-acting beta-agonist (SABA) ≤8 times/4 weeks for the treatment of symptoms
• There has been no change in asthma medication (dose or regimen) within 4 weeks prior to dosing
• Pre-short-acting β2 agonist (SABA) forced expiratory volume in 1 second (FEV1) of ≥80% of predicted normal values at screening
• Non-smokers for at least 6 months prior to screening and agrees not to smoke during the study
• Negative test results for smoking status at screening (urine cotinine) and pre-dose Day 1 (Smokerlyser)
• Female subjects of childbearing potential must be practising true abstinence when this is in line with the preferred and usual lifestyle of the subject (Periodic abstinence, e.g. calendar, ovulation, symptothermal, post-ovulation methods and withdrawal are not acceptable methods of contraception), or be using and willing to continue using a medically acceptable form of birth control for at least 1 month prior to screening (at least 3 months for hormonal contraceptives) and for at least 1 month after the last study drug administration

You may not qualify if:

• A history of a life-threatening asthma exacerbation that required intubation and mechanical ventilation
• History of severe asthma exacerbation in the last year that required the use of systemic corticosteroids (tablets, suspension or injection)
• Hospitalization or a visit to ER because of asthma in the last year
• Intensive care admission for asthma in the previous 5 years
• Any clinically significant abnormalities on clinical chemistry, haematology, or urinalysis, as judged by the investigator (at screening and/or Day -1)
• Clinically significant abnormalities on physical examination, medical history, 12-lead ECG, or vital signs, as judged by the investigator (at screening or pre-dose Day 1)
• A QTcF \>430 msec for male subjects and \>450 msec for female subjects on ECG at screening or pre-dose Day 1
• History or presence of any clinically significant illness (e.g., cardiovascular, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, musculoskeletal, or psychiatric) or any other condition, which in the opinion of the investigator would jeopardize the safety of the subject or the validity of the study results
• History or clinical evidence of other respiratory disease (e.g., COPD, cystic fibrosis)
• Recent (within 2 weeks) or current signs or symptoms of a respiratory infection at screening or pre-dose Day 1
• Currently taking theophylline or has taken theophylline in the 3 months prior to screening
• Use of non-prescription drugs within 3 days prior to Day 1
• Use of prescription medications (except acceptable asthma medications, acceptable forms of birth control, and hormone replacement) and recreational drugs within 14 days prior to Day 1
• Positive urine drug screen or breath alcohol test at screening or pre-dose Day 1
• Female subjects who are pregnant or lactating or who are planning to become pregnant within 30 days of study drug administration

Sponsors & Collaborators

• Biota Scientific Management Pty Ltd: lead
• Department of Health and Human Services: collaborator

Study Sites (1)

Respiratory Clinical Trials

London, W1G 8HU, United Kingdom

Location

MeSH Terms

Conditions

Asthma; Lymphoma, Follicular

Interventions

laninamivir; CS 8958

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders

Study Officials

• Jolanta Airey, Dr

  Biota Scientific Management Pty Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2013
• First Posted: December 30, 2013
• Study Start: October 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: February 1, 2014
• Last Updated: May 30, 2018

Record last verified: 2018-05

Locations

GB (1)