Chronic Obstructive Pulmonary Disease (COPD)Phase 1NCT01970618
Safety, Tolerability and Pharmacokinetics (PK) of RV1162 in Healthy Subjects and COPD Patients
A Phase 1 study testing RV1162 single dose, RV1162: 7 day repeat dose and RV1162: 14 day repeat dose in people with Chronic Obstructive Pulmonary Disease (COPD) and Healthy Volunteers, run by Respivert Ltd at 1 site in United Kingdom.
Trial summary
RV1162 is a new medicine being developed for possible treatment of 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 RV1162. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD), Healthy Volunteers
- What is being tested?
- RV1162 single dose, RV1162: 7 day repeat dose and RV1162: 14 day repeat dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2013to Nov 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 2 forms of contraception from screening until 4 months after the final dose of RV1162. Must not be a woman of child bearing potential for subjects in Part C, OR
- If a woman of non-childbearing potential must be amenorrhoeic for at least 1 year with an appropriate clinical profile, 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, from the first dose until 4 months after the final dose of RV1162.
- Have a 12-lead ECG consistent with normal cardiac function
- Capable of complying with all study restrictions and procedures including ability to use the study inhaler correctly.
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- Parts A \& B (healthy volunteers only)
- Aged between 18 and 50 years of age inclusive, at the time of signing the informed consent
- Healthy as determined by a physician, based on a full medical evaluation including medical history, physical examination and laboratory tests.
- Vital sign assessments within normal ranges
- Body mass index between 19 and 30 kg/m2 and body weight not less than 50 kg.
- Spirometry readings (FEV1 and FVC) to be ≥80% predicted value and FEV1/FVC ratio >0.7 at screening
- Are not taking prescription medications (with the exception of contraceptive or hormone replacement therapies) 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 and up to the final follow-up visit
- Part C (COPD patients only)
- Aged between 40 and 75 years of age inclusive, at the time of signing the informed consent
- Have a diagnosis of COPD with symptoms compatible with COPD for at least 1 year
- COPD severity classification for GOLD Grade II/III
- Current or previous smoker with a smoking history of ≥ 10 pack years
- Not have a clinical abnormality or laboratory parameters outside the reference range
- Able to produce a viable induced sputum sample at the screening visit.
Who cannot join
- Upper or lower respiratory tract infection within 4 weeks of screening
- 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
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- Donated blood or blood products or had substantial loss of blood (more than 500 mL) within 3 months study drug or intention to donate blood or blood products during the study.
- Received an experimental drug or used an experimental medical device within 3 months or within a period less than 5 times the drug's half-life, whichever is longer, before the first dose of the study drug is scheduled.
- If a woman, has a positive pregnancy test at screening or admission, is pregnant, breast-feeding or planning to become pregnant during the study, or is a woman of child bearing potential (subjects in Part C).
- Positive test for human immunodeficiency virus (HIV) 1 and 2 antibodies, hepatitis B virus (HBV) infection, or hepatitis C antibodies.
- Preplanned surgery or procedures that would interfere with the conduct of the study.
- Employee of the Investigator or study centre, with direct involvement in the proposed study or other studies under the direction of that Investigator or study centre, 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 of an average weekly intake of >21 units for males, or >14 units for females
- 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
- Parts A \& B (healthy volunteers only)
- History of smoking or use of nicotine-containing substances within the previous 6 months or a positive carbon monoxide test at screening or on admission
- Part C (COPD patients only)
- A history of life-threatening COPD including Intensive Care Unit admission and/or requiring intubation
- A history of > 1 hospitalisation for COPD in the previous 2 years prior to screening
- Evidence of cor pulmonale or clinically significant pulmonary hypertension.
- Requires routine treatment for COPD using one of the restricted therapies listed in the protocol within the 6 weeks before screening
- A current diagnosis of asthma, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, interstitial lung diseases or other active pulmonary diseases
- A history of chronic uncontrolled diseases that the Investigator believes are clinically significant.
- A history of sleep apnoea.
- Previous lung resection or lung reduction surgery.
- Active participation in a pulmonary rehabilitation program
- Alanine transaminase (ALT) > 1.5 x upper limit of normal (ULN) at the screening visit.
- Major surgery, (requiring general anesthesia) within 6 weeks before the screening visit, or will not have fully recovered from surgery, or planned surgery through the end of the study
- A disclosed history, or one known to the Investigator, of significant noncompliance in previous investigational studies or with prescribed medications
- A history of unstable, or uncontrolled hypertension, or has been diagnosed with hypertension in last 3 months
- Any other reason that the Investigator considers makes the subject unsuitable to participate
- Vital sign assessments outside ranges: blood pressure between 100 and 160 mmHg systolic, inclusive, and between 55 and 100 mmHg diastolic; heart rate 50 - 100 bpm.
- Requires oxygen, even on an occasional basis
Trial locations and contacts
1 site in 1 country.
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 RV1162 in Healthy Subjects and Subjects With Chronic Obstructive Pulmonary Disease.
RV1162 is a new medicine being developed for possible treatment of 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 RV1162.
- Being tested
- RV1162 single dose, RV1162 matching placebo single dose, RV1162: 7 day repeat dose, RV1162 matching placebo: 7 day repeat dose, RV1162: 14 day repeat dose
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RV1162 single doseDrug
Safety and tolerability of single escalating doses
RV1162 matching placebo single doseDrug
Safety and tolerability of single escalating doses
RV1162: 7 day repeat doseDrug
Safety and tolerability of a repeat dose
RV1162 matching placebo: 7 day repeat doseDrug
Safety and tolerability of a repeat dose
RV1162: 14 day repeat doseDrug
Safety and tolerability of repeat escalating doses
RV1162 matching placebo: 14 day repeat doseDrug
Safety and tolerability of repeat escalating doses
| Study group | Role | What they receive |
|---|---|---|
| Part A: single dose escalation (healthy subjects) | Experimental | Not described Receives: Drug: RV1162 single dose; Drug: RV1162 matching placebo single dose |
| Part B: 7 day repeat dose (healthy subjects) | Experimental | Not described Receives: Drug: RV1162: 7 day repeat dose; Drug: RV1162 matching placebo: 7 day repeat dose |
| Part C: 14 day repeat dose (COPD patients) | Experimental | Not described Receives: Drug: RV1162: 14 day repeat dose; Drug: RV1162 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 subject following dosing
Measured: Cohorts 1 & 2, 42 days: Cohort 3, 15 days: Cohort 4, 21 days: Cohorts 5 & 6, 28 days,
ECG assessment (12-lead ECG)
Change from pre-dose values
Measured: Cohorts 1 & 2, 42 days: Cohort 3, 15 days: Cohort 4, 21 days: Cohorts 5 & 6, 28 days
Vital sign assessment (blood pressure and heart rate)
Change from pre-dose values
Measured: Cohorts 1 & 2, 42 days: Cohort 3, 15 days: Cohort 4, 21 days: Cohorts 5 & 6, 28 days
Spirometry assessment (FEV1 & FVC)
Change from pre-dose values
Measured: Cohorts 1 & 2, 42 days: Cohort 3, 15 days: Cohort 4, 21 days: Cohorts 5 & 6, 28 days
Clinical laboratory assessments (blood and urine samples)
Change from pre-dose values
Measured: Cohorts 1 & 2, 42 days: Cohort 3, 15 days: Cohort 4, 21 days: Cohorts 5 & 6, 28 days
Secondary outcomes (1)
Plasma RV1162 levels
Measurement of RV1162 in blood after dosing
Measured: Part A: Cohorts 1 & 2 x 4 treatment periods (TP), Cohort 3 x 1 TP (0, 10, 15 & 30 min, 1 ,2, 4, 6, 8, 10, 12 & 24h post-dose) each TP; Part B (Cohort 4): 34 samples up to 21 days post-dose; Part C (Cohorts 5 & 6): 46 samples up to 28 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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
- 78 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
- NCT01970618
- Sponsor's protocol ID
- EST001
- Other IDs
- 2013 002329-44
- Status last verified
- Nov 2014
- First submitted
- 22 Oct 2013
- Last updated
- 20 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 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 RV1162 in Healthy Subjects and Subjects With Chronic Obstructive Pulmonary Disease.
- ClinicalTrials.gov ID
- NCT01970618
- Acronym / sponsor ID
- EST001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Respivert LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 28 Oct 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.
RV1162 is a new medicine being developed for possible treatment of 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 RV1162.
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 (healthy subjects) | Experimental | Drug: RV1162 single dose, Drug: RV1162 matching placebo single dose |
| Part B: 7 day repeat dose (healthy subjects) | Experimental | Drug: RV1162: 7 day repeat dose, Drug: RV1162 matching placebo: 7 day repeat dose |
| Part C: 14 day repeat dose (COPD patients) | Experimental | Drug: RV1162: 14 day repeat dose, Drug: RV1162 matching placebo: 14 day repeat dose |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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 2 forms of contraception from screening until 4 months after the final dose of RV1162. Must not be a woman of child bearing potential for subjects in Part C, OR
- If a woman of non-childbearing potential must be amenorrhoeic for at least 1 year with an appropriate clinical profile, 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, from the first dose until 4 months after the final dose of RV1162.
- Have a 12-lead ECG consistent with normal cardiac function
Key exclusion criteria (37 listed)
- Upper or lower respiratory tract infection within 4 weeks of screening
- 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 |
|---|---|---|
| RV1162 single doseSafety and tolerability of single escalating doses | Drug | Part A: single dose escalation (healthy subjects) |
| RV1162 matching placebo single doseSafety and tolerability of single escalating doses | Drug | Part A: single dose escalation (healthy subjects) |
| RV1162: 7 day repeat doseSafety and tolerability of a repeat dose | Drug | Part B: 7 day repeat dose (healthy subjects) |
| RV1162 matching placebo: 7 day repeat doseSafety and tolerability of a repeat dose | Drug | Part B: 7 day repeat dose (healthy subjects) |
| RV1162: 14 day repeat doseSafety and tolerability of repeat escalating doses | Drug | Part C: 14 day repeat dose (COPD patients) |
| RV1162 matching placebo: 14 day repeat doseSafety and tolerability of repeat escalating doses | Drug | Part C: 14 day repeat dose (COPD patients) |
Primary outcome
Incidence of treatment emergent adverse events
Time frame: Cohorts 1 & 2, 42 days: Cohort 3, 15 days: Cohort 4, 21 days: Cohorts 5 & 6, 28 days,
Assessment of the number of adverse events reported by subject following dosing
ECG assessment (12-lead ECG)
Time frame: Cohorts 1 & 2, 42 days: Cohort 3, 15 days: Cohort 4, 21 days: Cohorts 5 & 6, 28 days
Change from pre-dose values
Vital sign assessment (blood pressure and heart rate)
Time frame: Cohorts 1 & 2, 42 days: Cohort 3, 15 days: Cohort 4, 21 days: Cohorts 5 & 6, 28 days
Change from pre-dose values
Spirometry assessment (FEV1 & FVC)
Time frame: Cohorts 1 & 2, 42 days: Cohort 3, 15 days: Cohort 4, 21 days: Cohorts 5 & 6, 28 days
Change from pre-dose values
Clinical laboratory assessments (blood and urine samples)
Time frame: Cohorts 1 & 2, 42 days: Cohort 3, 15 days: Cohort 4, 21 days: Cohorts 5 & 6, 28 days
Change from pre-dose values
1 secondary outcome
Plasma RV1162 levels
Time frame: Part A: Cohorts 1 & 2 x 4 treatment periods (TP), Cohort 3 x 1 TP (0, 10, 15 & 30 min, 1 ,2, 4, 6, 8, 10, 12 & 24h post-dose) each TP; Part B (Cohort 4): 34 samples up to 21 days post-dose; Part C (Cohorts 5 & 6): 46 samples up to 28 days 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 20 Nov 2014.
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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.
Jerome Boscia, MD study director
Sponsor GmbH
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 RV1162 single dose, RV1162: 7 day repeat dose and RV1162: 14 day repeat dose in people with Chronic Obstructive Pulmonary Disease (COPD) and Healthy Volunteers, run by Respivert 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 21 inclusion and 37 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 20 Nov 2014. 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. 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: Cohorts 1 & 2, 42 days: Cohort 3, 15 days: Cohort 4, 21 days: Cohorts 5 & 6, 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 20 Nov 2014.