AsthmaPhase 1NCT01813084
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of RV1729
A Phase 1 study testing RV1729 single dose and RV1729: 14 day repeat dose in people with Asthma and Healthy Volunteers, run by Respivert Ltd at 2 sites in United Kingdom.
Trial summary
RV1729 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 and pharmacokinetics of single and repeat doses of RV1729. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Healthy Volunteers
- What is being tested?
- RV1729 single dose and RV1729: 14 day repeat dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- May 2013to Apr 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be a man or woman between 18 to 50 years of age, inclusive, at the time of signing the informed consent
- Sign an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study
- If a woman of childbearing potential, must have a documented menstrual period prior to the first dose and be willing and able to use two forms of contraception from screening to 90 days after the final dose of RV1729, OR
- If a woman of non-childbearing potential must be amenorrhoeic for greater than 1 year or have been permanently sterilised, OR
- If a man, must be willing and able to use one of the contraception methods listed in the protocol and agree not to donate sperm, the first dose until 90 days after they receive the final dose of RV1729.
- Body mass index between 19 and 30 kg/m2 (inclusive), and body weight not less than 50 kg
Show all 22Show fewer
- Vital sign assessments within normal ranges: blood pressure between 90 and 140 mmHg systolic, inclusive, and between 40 and 90 mmHg diastolic; heart rate 40 - 100 bpm
- Have a 12-lead ECG consistent with normal cardiac conduction and function
- Capable of complying with all study restrictions and procedures including ability to use the study Dry Powder Inhaler correctly
- Parts A \& B (healthy volunteers only)
- Healthy as determined by a physician, based on a full medical evaluation including medical history, physical examination, laboratory tests.
- Prebronchodilator spirometry readings (FEV1 and FVC) to be ≥ 80% predicted value and FEV1/FVC ratio > 0.7 at screening
- Are not taking prescription medications for 14 days prior to screening and agree not to use prescription medications throughout the duration of the study.
- Not taking over the counter medications for 14 days prior to Screening visit to the final follow up visit
- Part C (asthma patients only)
- Documented history of asthma, for at least 6 months prior and currently being treated with as needed short-acting beta -agonist therapy and daily inhaled corticosteroids
- Have a diagnosis of asthma. This may be confirmed with bronchodilator reversibility or a challenge test.
- Have a pre-bronchodilator forced expiratory volume in the first second (FEV1) ≥ 65% of predicted normal value
- Treated with a stable low or medium dose of inhaled corticosteroid for at least 4 weeks prior to screening
- Have stable asthma based on physician assessment at screening with no asthma exacerbation requiring augmentation of therapy in the 12 weeks prior to screening and no hospitalisation for asthma in the 5 years prior to screening
- Not have a clinical abnormality or laboratory parameters outside the reference range for the population being studied
- Not taking over the counter (OTC) medications and herbal medication for 14 days prior to screening visit and up to the final follow up visit
Who cannot join
- Upper or lower respiratory tract infection within 4 weeks of the screening visit
- Clinically significant abnormal values for haematology, clinical chemistry or urinalysis at screening
- History of, or a reason to believe a subject has a history of drug or alcohol abuse within the past 5 years
- Positive test for alcohol or drugs of abuse at screening or prior to dosing
- History of clinically significant allergies that would contraindicate participation
- Known allergy to the study drug or any of the excipients of the formulation
Show all 25Show fewer
- Donated blood or blood products or had substantial loss of blood (more than 500 mL) within 3 months before the study
- Received an experimental drug or used an experimental medical device within 3 months or within a period less than 10 times the drug's half life before the first dose of the study drug is scheduled
- If a woman, has a positive serum pregnancy test at screening or on admission, is pregnant, breast-feeding or planning to become pregnant during the study
- Positive test for human immunodeficiency virus (HIV) 1 and 2 antibodies, hepatitis B virus (HBV) infection, or hepatitis C antibodies
- History of smoking or use of nicotine-containing substances within the previous 6 months, or a positive carbon monoxide test at screening
- Preplanned surgery or procedures that would interfere with the conduct of the study
- Employee of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities
- History of regular alcohol consumption within 6 months of the study
- The subject is unable or unwilling to comply fully with the study protocol
- Subject is mentally or legally incapacitated
- Unable or unwilling to undergo multiple venepuncture 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
- Part C (asthma patients only)
- Administration of oral, injectable or dermal steroids within 3 months or intranasal steroids within 1 week of the screening visit.
- Has ever had an episode of life-threatening asthma
- Any acute or chronic illness or clinically relevant abnormality other than asthma
- Use of Cysteine within 24 hours of screening and throughout the study period
- Has severe asthma based on Investigator assessment
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Study site
London, NW10 7EW
Study site
Manchester, M23 9QZ
About this study
Official title: A Randomised, Double Blind, Placebo-controlled, Three Part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Treatment With Single and Repeat Doses of Inhaled RV1729 in Healthy Subjects and Subjects With Mild to Moderate Asthma
RV1729 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 and pharmacokinetics of single and repeat doses of RV1729.
- Conditions
- Asthma, Healthy Volunteers
- Being tested
- RV1729 single dose, RV1729 matching placebo single dose, RV1729: 14 day repeat dose, RV1729 matching placebo: 14 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.
RV1729 single doseDrug
Safety and tolerability of single escalating doses
RV1729 matching placebo single doseDrug
Safety and tolerability of single escalating doses
RV1729: 14 day repeat doseDrug
Safety and tolerability of repeat escalating doses
RV1729 matching placebo: 14 day repeat doseDrug
Safety and tolerability of repeat escalating doses
| Study group | Role | What they receive |
|---|---|---|
| Part A: single dose escalation | Experimental | Not described Receives: Drug: RV1729 single dose; Drug: RV1729 matching placebo single dose |
| Part B: 14 day repeat dose escalation (healthy volunteers) | Experimental | Not described Receives: Drug: RV1729: 14 day repeat dose; Drug: RV1729 matching placebo: 14 day repeat dose |
| Part C: 14 day repeat dose (asthma patients) | Experimental | Not described Receives: Drug: RV1729: 14 day repeat dose; Drug: RV1729 matching placebo: 14 day repeat dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events
Assessment of the number of adverse events reported by subjects following dosing.
Measured: Cohort 1, 49 days: Cohorts 2 & 3, 21 days; Cohorts 4, 5, 6 & 7, 28 days
ECG Assessment (12-lead ECG)
Change from pre-dose values.
Measured: Cohort 1, 49 days: Cohorts 2 & 3, 21 days; Cohorts 4, 5, 6 & 7, 28 days
Vital sign assessment (blood pressure & heart rate)
Change from pre-dose values.
Measured: Cohort 1, 49 days: Cohorts 2 & 3, 21 days; Cohorts 4, 5, 6 & 7, 28 days
Spirometry assessment (FEV1 & FVC)
Change from pre-dose values
Measured: Cohort 1, 49 days: Cohorts 2 & 3, 21 days; Cohorts 4, 5, 6 & 7, 28 days
Clinical laboratory assessments (blood and urine samples)
Change from pre-dose values
Measured: Cohort 1, 49 days: Cohorts 2 & 3, 21 days; Cohorts 4, 5, 6 & 7, 28 days
Secondary outcomes (1)
Plasma RV1729 levels
Measured: Cohort 1: Day 1 (0,10,15&30min,1,2,4,6&24h), 5 treatment periods. Cohorts 2&3: Day 1 (0,10,15&30min 1,2,4,6,8,12h), Days 2-8 (24,48,72,96,120,144&168h). Cohorts 4,5,6&7: Days 1, 7&14 (0,10,15&30min,1,2,4,6,8,10,12&24h) & Days 8-13 & 16-21 & 28 (0h)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2013 (estimated)
- Study startMay 2013
- Primary completionApr 2014
- Study completionApr 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, Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Respivert Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jerome Boscia, MD, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01813084
- Sponsor's protocol ID
- STN001
- Other IDs
- 2012-005452-42
- Status last verified
- Apr 2014
- First submitted
- 14 Mar 2013
- Last updated
- 24 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double Blind, Placebo-controlled, Three Part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Treatment With Single and Repeat Doses of Inhaled RV1729 in Healthy Subjects and Subjects With Mild to Moderate Asthma
- ClinicalTrials.gov ID
- NCT01813084
- Acronym / sponsor ID
- STN001
- Conditions
- Asthma, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Respivert LtdIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 18 Mar 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.
RV1729 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 and pharmacokinetics of single and repeat doses of RV1729.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A: single dose escalation | Experimental | Drug: RV1729 single dose, Drug: RV1729 matching placebo single dose |
| Part B: 14 day repeat dose escalation (healthy volunteers) | Experimental | Drug: RV1729: 14 day repeat dose, Drug: RV1729 matching placebo: 14 day repeat dose |
| Part C: 14 day repeat dose (asthma patients) | Experimental | Drug: RV1729: 14 day repeat dose, Drug: RV1729 matching placebo: 14 day repeat dose |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (22 listed)
- Be a man or woman between 18 to 50 years of age, inclusive, at the time of signing the informed consent
- Sign an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study
- If a woman of childbearing potential, must have a documented menstrual period prior to the first dose and be willing and able to use two forms of contraception from screening to 90 days after the final dose of RV1729, OR
- If a woman of non-childbearing potential must be amenorrhoeic for greater than 1 year or have been permanently sterilised, OR
- If a man, must be willing and able to use one of the contraception methods listed in the protocol and agree not to donate sperm, the first dose until 90 days after they receive the final dose of RV1729.
Key exclusion criteria (25 listed)
- Upper or lower respiratory tract infection within 4 weeks of the screening visit
- Clinically significant abnormal values for haematology, clinical chemistry or urinalysis at screening
- History of, or a reason to believe a subject has a history of drug or alcohol abuse within the past 5 years
- Positive test for alcohol or drugs of abuse at screening or prior to dosing
- History of clinically significant allergies that would contraindicate participation
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 |
|---|---|---|
| RV1729 single doseSafety and tolerability of single escalating doses | Drug | Part A: single dose escalation |
| RV1729 matching placebo single doseSafety and tolerability of single escalating doses | Drug | Part A: single dose escalation |
| RV1729: 14 day repeat doseSafety and tolerability of repeat escalating doses | Drug | Part B: 14 day repeat dose escalation (healthy volunteers), Part C: 14 day repeat dose (asthma patients) |
| RV1729 matching placebo: 14 day repeat doseSafety and tolerability of repeat escalating doses | Drug | Part B: 14 day repeat dose escalation (healthy volunteers), Part C: 14 day repeat dose (asthma patients) |
Primary outcome
Incidence of treatment emergent adverse events
Time frame: Cohort 1, 49 days: Cohorts 2 & 3, 21 days; Cohorts 4, 5, 6 & 7, 28 days
Assessment of the number of adverse events reported by subjects following dosing.
ECG Assessment (12-lead ECG)
Time frame: Cohort 1, 49 days: Cohorts 2 & 3, 21 days; Cohorts 4, 5, 6 & 7, 28 days
Change from pre-dose values.
Vital sign assessment (blood pressure & heart rate)
Time frame: Cohort 1, 49 days: Cohorts 2 & 3, 21 days; Cohorts 4, 5, 6 & 7, 28 days
Change from pre-dose values.
Spirometry assessment (FEV1 & FVC)
Time frame: Cohort 1, 49 days: Cohorts 2 & 3, 21 days; Cohorts 4, 5, 6 & 7, 28 days
Change from pre-dose values
Clinical laboratory assessments (blood and urine samples)
Time frame: Cohort 1, 49 days: Cohorts 2 & 3, 21 days; Cohorts 4, 5, 6 & 7, 28 days
Change from pre-dose values
1 secondary outcome
Plasma RV1729 levels
Time frame: Cohort 1: Day 1 (0,10,15&30min,1,2,4,6&24h), 5 treatment periods. Cohorts 2&3: Day 1 (0,10,15&30min 1,2,4,6,8,12h), Days 2-8 (24,48,72,96,120,144&168h). Cohorts 4,5,6&7: Days 1, 7&14 (0,10,15&30min,1,2,4,6,8,10,12&24h) & Days 8-13 & 16-21 & 28 (0h)
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 24 Apr 2014.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
Jerome Boscia, MD 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 RV1729 single dose and RV1729: 14 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 22 inclusion and 25 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 24 Apr 2014. 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 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?
Incidence of treatment emergent adverse events (time frame: Cohort 1, 49 days: Cohorts 2 & 3, 21 days; Cohorts 4, 5, 6 & 7, 28 days). The study lists 5 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 24 Apr 2014.