AsthmaPhase 1NCT02022761
Safety, Tolerability and Pharmacokinetics of Inhaled Laninamivir Octanoate TwinCaps® DPI in Adults With Chronic Asthma
A Phase 1 study testing Laninamivir octanoate in people with Asthma, run by Biota Scientific Management Pty Ltd at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Laninamivir octanoate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2013to Feb 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
- Male subjects of reproductive potential who are not truly abstinent must be using and willing to continue using medically acceptable contraceptive precautions from screening and for at least 1 month after the last study drug administration
- Female subjects must have a negative serum pregnancy test at screening and a negative urine pregnancy test pre-dose Day 1
- Able to speak, read, and understand English sufficiently to understand the nature of the study, to provide informed consent, and to allow completion of all study assessments
- Must provide written informed consent prior to the initiation of any protocol-specific procedures
Who cannot join
- 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)
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- 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
- History of allergy, hypersensitivity, or serious adverse reaction to lactose or neuraminidase inhibitors
- Previous exposure to laninamivir octanoate
- Positive for Hepatitis B surface antigen, Hepatitis C virus antibody, or Human Immunodeficiency Virus (HIV) p24 antigen/antibodies at screening
- Donation or loss of ≥500 mL whole blood within 2 months prior to Day 1
- Current or pending legal charges or currently on probation, based on subject report
- Receipt of an investigational product in a clinical trial within 30 days or 5 half-lives, whichever is longer, prior to Day 1
- Concurrent enrolment in any other type of medical research, judged by the investigator not to be scientifically or medically compatible with this study
- An employee of the sponsor or research site personnel directly affiliated with this study or their immediate family members defined as a spouse, parent, sibling, or child, whether biological or legally adopted
- A subject who, in the opinion of the investigator, is not considered to be suitable and is unlikely to comply with the study protocol for any reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Inhaled Laninamivir Octanoate in Adults With Chronic Asthma
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.
Read the detailed description
32 subjects, as two sequential groups of 16 subjects at each dose level (40 mg and 80 mg), will be randomised 3:1 to receive active drug or matching placebo.
Males and females aged 18 to 65 years inclusive, with mild or moderate chronic asthma.
Stratum 1: Mild asthma - requiring treatment consistent with Global Initiative for Asthma (GINA) Step 2 Stratum 2: Moderate asthma - requiring treatment consistent with GINA Step 3
Following a screening period of up to 30 days, eligible consenting subjects will be admitted to the clinic on the morning of Day 1. Laninamivir octanoate will be administered on Day 1. Subjects will remain in the clinic until Day 3 and will return for subsequent outpatient visits on Day 5, Day 6 and Day 7. A final follow-up visit for safety evaluations will occur on Day 14 ± 1 (or at the time of premature discontinuation). Each subject will participate in the study for approximately 7 weeks.
- Conditions
- Asthma
- Being tested
- Laninamivir octanoate
- Keywords
- Mild or moderate asthmatics, Adults, Laninamivir
- Medical subject headings
- Asthma, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laninamivir octanoateDrug
Also called CS-8958
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)
| Study group | Role | What they receive |
|---|---|---|
| 40 mg Laninamivir octanoate | Experimental | Dry Powder Inhaler Receives: Drug: Laninamivir octanoate |
| 80 mg Laninamivir octanoate | Experimental | Dry Powder Inhaler Receives: Drug: Laninamivir octanoate |
| Matching placebo | Placebo comparator | Dry Powder Inhaler Receives: Drug: Laninamivir octanoate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Cohort 1 - Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 96, 120 and 144 hours post dose Cohort 2 - Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 15, 16, 18, 20, 24, 36, 48, 96, 120 and 144 hours post dose
Pharmacokinetic concentration data and PK parameters will be calculated and summarized.
Measured: Samples are collected up to 144 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biota Scientific Management Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Department of Health and Human Services
- Responsible party
- Sponsor
- Investigators
- Jolanta Airey, Dr, Study director, Biota Scientific Management Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02022761
- Sponsor's protocol ID
- BTA51-350-101
- Status last verified
- May 2018
- First submitted
- 22 Dec 2013
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Inhaled Laninamivir Octanoate in Adults With Chronic Asthma
- ClinicalTrials.gov ID
- NCT02022761
- Acronym / sponsor ID
- BTA51-350-101
- Conditions
- Asthma
- Keywords
- Mild or moderate asthmatics, Adults, Laninamivir
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Biota Scientific Management Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Department of Health and Human Services
- Study start
- Oct 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 30 Dec 2013 (estimated)
- Results
- Not posted in the source record
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 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.
Detailed description
32 subjects, as two sequential groups of 16 subjects at each dose level (40 mg and 80 mg), will be randomised 3:1 to receive active drug or matching placebo.
Males and females aged 18 to 65 years inclusive, with mild or moderate chronic asthma.
Stratum 1: Mild asthma - requiring treatment consistent with Global Initiative for Asthma (GINA) Step 2 Stratum 2: Moderate asthma - requiring treatment consistent with GINA Step 3
Following a screening period of up to 30 days, eligible consenting subjects will be admitted to the clinic on the morning of Day 1. Laninamivir octanoate will be administered on Day 1. Subjects will remain in the clinic until Day 3 and will return for subsequent outpatient visits on Day 5, Day 6 and Day 7. A final follow-up visit for safety evaluations will occur on Day 14 ± 1 (or at the time of premature discontinuation). Each subject will participate in the study for approximately 7 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 40 mg Laninamivir octanoate | Experimental | Drug: Laninamivir octanoateDry Powder Inhaler |
| 80 mg Laninamivir octanoate | Experimental | Drug: Laninamivir octanoateDry Powder Inhaler |
| Matching placebo | Placebo comparator | Drug: Laninamivir octanoateDry Powder Inhaler |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (24 listed)
- 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)
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 |
|---|---|---|
| Laninamivir octanoateAlso: CS-895840 mg dose consists of 2 laninamivir octanoate TwinCaps® DPI 80 mg dose consists of 4 laninamivir octanoate TwinCaps® DPI (2 administered 12 hours apart) | Drug | 40 mg Laninamivir octanoate, 80 mg Laninamivir octanoate, Matching placebo |
Primary outcome
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.
Time frame: Subjects assessed at clinic visits and up to 14 days post-dose
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
1 secondary outcome
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
Time frame: Samples are collected up to 144 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
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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.
Jolanta Airey, Dr study director
Biota Scientific Management Pty Ltd
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 Laninamivir octanoate in people with Asthma, run by Biota Scientific Management Pty Ltd at 1 site in United Kingdom.
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 19 inclusion and 24 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 30 May 2018. 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 Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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. (time frame: Subjects assessed at clinic visits and up to 14 days post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2018.