AsthmaPhase 1NCT02517359
A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Repeat Doses of RV6153
A Phase 1 study testing RV6153 single dose, RV6153 14 day repeat dose and RV6153 28 day repeat dose in people with Asthma and Healthy Volunteers, run by Respivert Ltd at 2 sites in United Kingdom.
Trial summary
RV6153 is a new medicine being developed for possible treatment of asthma and smoking related lung disease (also known as chronic obstructive pulmonary disease - COPD). The main purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat doses of RV6153 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Healthy Volunteers
- What is being tested?
- RV6153 single dose, RV6153 14 day repeat dose and RV6153 28 day repeat dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jul 2015to Feb 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cohorts 1 to 13 (all subjects)
- Subject must be a man or woman aged between 18 to 65 years of age, inclusive: Women of non-childbearing potential only - defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile or permanently sterilised. Men who are willing and able to use suitable contraception methods listed in Section 4.5.1, from the time of the first dose of study medication until 90 days after discharge from the study.
- A woman must have a negative serum β human chorionic gonadotropin (β-hCG) test at screening and a negative urine pregnancy test at Day -1.
- Subject must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
- Each subject must sign an informed consent form (ICF)
- Body weight ≥50 kg and BMI within the range 19-29 kg/m2 (inclusive).
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- Average QTcF <450 msec at screening and Day -1 visits
- Vital sign assessments within normal ranges.
- Cohorts 1 to 11 and 13 (healthy volunteers and smokers only)
- Healthy as determined by a physician, based on a full medical evaluation including medical history, physical examination, laboratory tests.
- Spirometry readings (FEV1 and FVC) to be ≥80% predicted value and FEV1/FVC ratio >0.7 at screening.
- Cohort 12 (asthma patients only)
- Documented history of asthma, first diagnosed at least 6 months prior to the screening visit.
- Currently being treated with daily standard of care asthma therapy
- Have a diagnosis of asthma confirmed at screening by bronchodilator reversibility.
- Have stable asthma based on physician assessment at screening and prior to randomisation, with no asthma exacerbation requiring augmentation of therapy in the 12 weeks prior to screening and no hospitalization or visit to accident and emergency for asthma in the 12 months prior to screening.
- Have a pre-bronchodilator forced expiratory volume in the first second (FEV1) ≥60% and ≤85% of predicted normal value at screening.
- Subject must be otherwise healthy on the basis of full medical evaluation performed at screening.
- Cohort 13 (smokers only)
- Subjects who are current daily cigarette smokers.
Who cannot join
- Cohorts 1 to 13 (all subjects)
- Upper or lower respiratory tract infection within 4 weeks of the screening visit and prior to randomisation.
- A positive pre-study hepatitis B surface antigen or positive hepatitis C antibody result at screening.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities.
- Positive test for alcohol or drugs of abuse.
- Use of prescription medications within 14 days prior to the screening visit and agree not to use prescription medications throughout the duration of the study.
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- Are taking over the counter (OTC) medications for 14 days prior to Screening visit and agree to refrain from taking such medications throughout the study.
- History of regular alcohol consumption within 6 months of the study
- Definite or suspected history of drug or alcohol abuse within the previous 5 years.
- A positive test for HIV antibody.
- Received an experimental drug or used an experimental medical device within 3 months or within a period less than five times the drug's half-life before the first dose of the study drug is scheduled.
- Allergy to any of the active or inactive ingredients (including lactose and milk protein intolerance) in the study medication.
- History of drug, or other allergy that would contraindicate their participation.
- A disclosed history or one known to the Investigator, of significant non-compliance in previous investigational studies or with prescribed medications.
- Donated blood or blood products or had substantial loss of blood (more than 500 mL) within 3 months before the first administration of study drug or intention to donate blood or blood products during the study.
- Subject is mentally or legally incapacitated.
- Subject is an employee of the Sponsor or contract research organization (CRO), or a relative of an employee of the Sponsor or CRO.
- Unable or unwilling to undergo multiple venipuncture procedures or the subject has poor access to veins suitable for cannulation.
- Any other reason that the Investigator considers makes the subject unsuitable to participate.
- Cohorts 1 to 11 (healthy subjects only)
- Any acute or chronic illness or clinically relevant abnormality identified on the screening medical assessment.
- The subject is a smoker or has smoked or used nicotine-containing products (including e-cigarettes or other nicotine containing products) within the 6 months prior to screening or has a smoking history of ≥5 pack years.
- Positive urine cotinine test at the screening visit indicative of smoking or use of tobacco or nicotine-containing products.
- Cohort 12 (asthma patients only)
- Has ever had an episode of life-threatening asthma defined as respiratory arrest, intubation for asthma, or ICU admission for asthma
- Has been hospitalized for greater than 24 hours due to asthma in the 5 years prior to the study.
- Has experienced an asthma exacerbation in the 3 months prior to screening (and prior to randomisation) requiring management with systemic or injectable steroids.
- Has uncontrolled (severe) asthma and/or use of the study prohibited asthma medications.
- The subject is a smoker (regular or irregular), or has smoked or used nicotine-containing products (including e-cigarettes) within the 6 months prior to screening (or a smoking history ≥10 pack years).
- Positive urine cotinine test at the screening visit, and at Day -1, indicative of smoking or use of tobacco or nicotine-containing products.
- Cohort 13 (smokers only)
- Any acute or chronic illness, including a diagnosis of COPD, or clinically relevant abnormality identified on the screening medical assessment.
- Subjects who are unable to produce a viable sputum sample at screening
- Subjects whose primary consumption of tobacco is via methods other than cigarettes. Primary methods of tobacco consumption that are excluded include, but are not limited to pipes, cigars and e-cigarettes.
- Urinary cotinine levels at screening <30 nanograms (ng)/mL.
- Subjects who have asthma or a history of asthma (except in childhood and which has now remitted).
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Study site
Manchester, M23 9QZ
Study site
Nottingham, NG11 6JS
About this study
Official title: A Randomized, Double Blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Treatment With Single and Repeat Doses of Inhaled RV6153 in Healthy Subjects and Subjects With Stable Asthma.
RV6153 is a new medicine being developed for possible treatment of asthma and smoking related lung disease (also known as chronic obstructive pulmonary disease - COPD).
The main purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat doses of RV6153
- Conditions
- Asthma, Healthy Volunteers
- Being tested
- RV6153 single dose, RV6153 matching placebo single dose, RV6153 14 day repeat dose, RV6153 matching placebo 14 day repeat dose, RV6153 28 day repeat dose
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RV6153 single doseDrug
Safety and tolerability of single doses
RV6153 matching placebo single doseDrug
Safety and tolerability of single doses
RV6153 14 day repeat doseDrug
Safety and tolerability of repeat doses
RV6153 matching placebo 14 day repeat doseDrug
Safety and tolerability of repeat doses
RV6153 28 day repeat doseDrug
Safety and tolerability of repeat doses
RV6153 matching placebo 28 day repeat doseDrug
Safety and tolerability of repeat doses
| Study group | Role | What they receive |
|---|---|---|
| Single dose, healthy volunteers | Experimental | Not described Receives: Drug: RV6153 single dose; Drug: RV6153 matching placebo single dose |
| 14 day repeat dose, healthy volunteers | Experimental | Not described Receives: Drug: RV6153 14 day repeat dose; Drug: RV6153 matching placebo 14 day repeat dose |
| 28 day repeat dose, healthy volunteers | Experimental | Not described Receives: Drug: RV6153 28 day repeat dose; Drug: RV6153 matching placebo 28 day repeat dose |
| 14 day repeat dose, asthma patients | Experimental | Not described Receives: Drug: RV6153 14 day repeat dose; Drug: RV6153 matching placebo 14 day repeat dose |
| 14 day repeat dose, smokers | Experimental | Not described Receives: Drug: RV6153 14 day repeat dose; Drug: RV6153 matching placebo 14 day repeat dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of single and repeat doses assessed by incidence of treatment emergent adverse events
Assessment of the number of adverse events reported by subjects following dosing
Measured: Up to 29 days post final dose
Safety and tolerability of single and repeat doses assessed by ECG (12-lead ECG)
12-lead ECGs will be obtained using an ECG machine that automatically calculates heart rate and measures PR, QRS, QT, and QTcB/QTcF intervals. ECGs will be measured after resting for 5 minutes
Measured: Up to 29 days post final dose
Safety and tolerability of single and repeat doses assessed by vital sign measurement (blood pressure & heart rate)
Blood pressure heart rate will be assessed together using an automated device after resting for 5 minutes. Blood pressure will include systolic and diastolic measurements.
Measured: Up to 29 days post final dose
Safety and tolerability of single and repeat doses assessed by respiration rate
Respiration rate will be measured after resting for 5 minutes
Measured: Up to 29 days post final dose
Safety and tolerability of single and repeat doses assessed by temperature
Temperature will be measured orally
Measured: Up to 29 days post final dose
Safety and tolerability of single and repeat doses assessed by spirometry
Pulmonary function test measured from forced expiratory volume in 1 second (FEV1). Pulmonary function test will be repeated until three technically acceptable measurements have been made.
Measured: Up to 29 days post final dose
Safety and tolerability of single and repeat doses by assessment of clinical laboratory tests
Clinical laboratory tests include haematology, clinical chemistry, urinalysis and additional parameters
Measured: Up to 29 days post final dose
Pharmacodynamic (PD) effect of repeat doses of RV6153 assessed by sputum cell biomarkers
Sputum samples will be collected to evaluate PD effects of repeat doses of RV6153 by assessment of phosphatidylinositol biphosphate (PIP2) and phosphatidylinositol triphosphate (PIP3).
Measured: Cohort 13 (subjects who smoke) only - assessments at screening and Days 1, 7 & 14
Secondary outcomes (1)
Plasma RV6153 levels
Measured: Cohorts 1-9: Day 1, 10 samples, Days 2,8,15&29, 1 sample per day; Cohorts 10, 12 & 13: Days 1,7&14, 10 samples per day, Days 2,8-13,1,21,28&42, 1 sample per day; Cohort 11: Days 1,14&28, 10 samples per day, Days 7,21,26,27,29,35,42&56, 1 sample per day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Why it stopped: Preset pharmacokinetic stopping criteria met at lower doses than expected.
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, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Respivert Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher O'Brien, MD, PhD, FCCP, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02517359
- Sponsor's protocol ID
- SFT001
- Other IDs
- 2015-000440-41, 2015
- Status last verified
- Mar 2016
- First submitted
- 28 Jul 2015
- Last updated
- 4 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Treatment With Single and Repeat Doses of Inhaled RV6153 in Healthy Subjects and Subjects With Stable Asthma.
- ClinicalTrials.gov ID
- NCT02517359
- Acronym / sponsor ID
- SFT001
- Conditions
- Asthma, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Preset pharmacokinetic stopping criteria met at lower doses than expected.
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Respivert LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 7 Aug 2015 (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.
RV6153 is a new medicine being developed for possible treatment of asthma and smoking related lung disease (also known as chronic obstructive pulmonary disease - COPD).
The main purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat doses of RV6153
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Single dose, healthy volunteers | Experimental | Drug: RV6153 single dose, Drug: RV6153 matching placebo single dose |
| 14 day repeat dose, healthy volunteers | Experimental | Drug: RV6153 14 day repeat dose, Drug: RV6153 matching placebo 14 day repeat dose |
| 28 day repeat dose, healthy volunteers | Experimental | Drug: RV6153 28 day repeat dose, Drug: RV6153 matching placebo 28 day repeat dose |
| 14 day repeat dose, asthma patients | Experimental | Drug: RV6153 14 day repeat dose, Drug: RV6153 matching placebo 14 day repeat dose |
| 14 day repeat dose, smokers | Experimental | Drug: RV6153 14 day repeat dose, Drug: RV6153 matching placebo 14 day repeat dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Cohorts 1 to 13 (all subjects)
- Subject must be a man or woman aged between 18 to 65 years of age, inclusive: Women of non-childbearing potential only - defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile or permanently sterilised. Men who are willing and able to use suitable contraception methods listed in Section 4.5.1, from the time of the first dose of study medication until 90 days after discharge from the study.
- A woman must have a negative serum β human chorionic gonadotropin (β-hCG) test at screening and a negative urine pregnancy test at Day -1.
- Subject must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
- Each subject must sign an informed consent form (ICF)
Key exclusion criteria (36 listed)
- Cohorts 1 to 13 (all subjects)
- Upper or lower respiratory tract infection within 4 weeks of the screening visit and prior to randomisation.
- A positive pre-study hepatitis B surface antigen or positive hepatitis C antibody result at screening.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities.
- Positive test for alcohol or drugs of abuse.
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 |
|---|---|---|
| RV6153 single doseSafety and tolerability of single doses | Drug | Single dose, healthy volunteers |
| RV6153 matching placebo single doseSafety and tolerability of single doses | Drug | Single dose, healthy volunteers |
| RV6153 14 day repeat doseSafety and tolerability of repeat doses | Drug | 14 day repeat dose, asthma patients, 14 day repeat dose, healthy volunteers, 14 day repeat dose, smokers |
| RV6153 matching placebo 14 day repeat doseSafety and tolerability of repeat doses | Drug | 14 day repeat dose, asthma patients, 14 day repeat dose, healthy volunteers, 14 day repeat dose, smokers |
| RV6153 28 day repeat doseSafety and tolerability of repeat doses | Drug | 28 day repeat dose, healthy volunteers |
| RV6153 matching placebo 28 day repeat doseSafety and tolerability of repeat doses | Drug | 28 day repeat dose, healthy volunteers |
Primary outcome
Safety and tolerability of single and repeat doses assessed by incidence of treatment emergent adverse events
Time frame: Up to 29 days post final dose
Assessment of the number of adverse events reported by subjects following dosing
Safety and tolerability of single and repeat doses assessed by ECG (12-lead ECG)
Time frame: Up to 29 days post final dose
12-lead ECGs will be obtained using an ECG machine that automatically calculates heart rate and measures PR, QRS, QT, and QTcB/QTcF intervals. ECGs will be measured after resting for 5 minutes
Safety and tolerability of single and repeat doses assessed by vital sign measurement (blood pressure & heart rate)
Time frame: Up to 29 days post final dose
Blood pressure heart rate will be assessed together using an automated device after resting for 5 minutes. Blood pressure will include systolic and diastolic measurements.
Safety and tolerability of single and repeat doses assessed by respiration rate
Time frame: Up to 29 days post final dose
Respiration rate will be measured after resting for 5 minutes
Safety and tolerability of single and repeat doses assessed by temperature
Time frame: Up to 29 days post final dose
Temperature will be measured orally
Safety and tolerability of single and repeat doses assessed by spirometry
Time frame: Up to 29 days post final dose
Pulmonary function test measured from forced expiratory volume in 1 second (FEV1). Pulmonary function test will be repeated until three technically acceptable measurements have been made.
Safety and tolerability of single and repeat doses by assessment of clinical laboratory tests
Time frame: Up to 29 days post final dose
Clinical laboratory tests include haematology, clinical chemistry, urinalysis and additional parameters
Pharmacodynamic (PD) effect of repeat doses of RV6153 assessed by sputum cell biomarkers
Time frame: Cohort 13 (subjects who smoke) only - assessments at screening and Days 1, 7 & 14
Sputum samples will be collected to evaluate PD effects of repeat doses of RV6153 by assessment of phosphatidylinositol biphosphate (PIP2) and phosphatidylinositol triphosphate (PIP3).
1 secondary outcome
Plasma RV6153 levels
Time frame: Cohorts 1-9: Day 1, 10 samples, Days 2,8,15&29, 1 sample per day; Cohorts 10, 12 & 13: Days 1,7&14, 10 samples per day, Days 2,8-13,1,21,28&42, 1 sample per day; Cohort 11: Days 1,14&28, 10 samples per day, Days 7,21,26,27,29,35,42&56, 1 sample per day
Results and safety
The study was stopped early (reason given: Preset pharmacokinetic stopping criteria met at lower doses than expected.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2016.
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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.
Christopher O'Brien, MD, PhD, FCCP study director
Sponsor GmbH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RV6153 single dose, RV6153 14 day repeat dose and RV6153 28 day repeat dose in people with Asthma and Healthy Volunteers, run by Respivert Ltd at 2 sites 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 20 inclusion and 36 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: stopped early, as of the sponsor's last update on 4 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 was stopped early (reason given: Preset pharmacokinetic stopping criteria met at lower doses than expected.). Results are not available in the source record.
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?
Safety and tolerability of single and repeat doses assessed by incidence of treatment emergent adverse events (time frame: Up to 29 days post final dose). The study lists 8 primary outcomes in all. 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 4 Mar 2016.