COPDPhase 1NCT01661244
A Study to Investigate the Safety and Tolerability of a New Inhaled Formulation of RV568 in Healthy Volunteers
A Phase 1 study testing RV568 single dose and RV568 repeat dose in people with COPD and Healthy Volunteers, run by Respivert Ltd at 1 site in United Kingdom.
Trial summary
RV568 is being developed as a possible treatment of smoking related lung disease (also known as Chronic Obstructive Pulmonary Disease - COPD). The main purpose of this study is to examine the safety and tolerability of a new inhaled formulation of RV568 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD, Healthy Volunteers
- What is being tested?
- RV568 single dose and RV568 repeat dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2012to Feb 2013
- 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
- Male or female between 18 and 65 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.
- Body weight ≥50 kg and body mass index within the range 19-29 kg/m2 (inclusive).
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Average QTc(B) or QTc(F) <450 msec (or QTc <480 msec in healthy subjects with right bundle branch block).
- Capable of complying with all study restrictions and procedures including ability to use the Dry Powder Inhaler correctly.
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- Spirometry readings (FEV1 and FVC) to be ≥ 80% predicted value and FEV1/FVC ratio > 0.7 calculated using ECCS reference equations.
- Vital sign assessments within normal ranges (systolic blood pressure (SBP) 90 140 mm/Hg; diastolic blood pressure (DBP) 55 - 90 mm/Hg; heart rate (HR) 40 - 100 bpm).
- Agree not to use prescription medications within 14 days before first administration of study medication and through the duration of the study (with the exception of contraception and hormone replacement therapy (HRT)).
- Agree not to use over the counter (OTC) medications (including corticosteroids, decongestants, antihistamines, aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs)) and herbal medication (including, but not limited to, herbal tea and St. John's Wort), within 14 days before first administration of study medication and through to the final follow up visit, unless approved by the Investigator and Sponsor Medical Monitor. Occasional use of paracetamol at recommended doses (≤ 1 g/ 6 hours and ≤ 2 g/day) and continued pre-existing use of vitamins at recommended doses is allowed.
Who cannot join
- Any acute or chronic illness or clinically relevant abnormality identified on the screening medical assessment, laboratory tests or ECG.
- Upper or lower respiratory tract infection within 4 weeks of the screening visit.
- 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 (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Positive urinary drugs or breath alcohol test at screening or prior to dosing.
- The Investigator suspects drug or alcohol abuse.
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- A positive test for human immunodeficiency virus antibody.
- History of regular alcohol consumption within 6 months of the study.
- The subject has participated in any other study of an investigational drug during the 3 months before receipt of the first dose of study medication or has previously received RV568.
- Regular use of prescription or non-prescription drugs within 14 days prior to the first dose of study medication.
- Allergy to any of the active or inactive ingredients in the study medication.
- History of drug, or other allergy that, in the opinion of the Investigator or Sponsor Medical Monitor, would contraindicate their participation.
- The subject is a smoker (regular or irregular), or has smoked or used nicotine-containing products within the 6 months prior to screening.
- Positive carbon monoxide breath test at the screening visit indicative of smoking or use of tobacco or nicotine-containing products.
- Donation of blood in excess of 500 mL within a 3 month period prior to screening, or if study participation would result in blood loss in excess of 500 mL in a 3 month period.
- The subject is unable or unwilling to comply fully with the study protocol.
- 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 venepuncture procedures or the subject has poor access to veins suitable for cannulation.
- A positive pregnancy test or is a lactating (nursing) female.
- Any other reason that the Investigator considers makes the subject unsuitable to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Two Part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Treatment With Single and Repeat Doses of Inhaled RV568 in Healthy Volunteers
RV568 is being developed as a possible treatment of smoking related lung disease (also known as Chronic Obstructive Pulmonary Disease - COPD).
The main purpose of this study is to examine the safety and tolerability of a new inhaled formulation of RV568 in healthy volunteers. The study will be run in two parts; Part A and Part B. Part A (Cohorts 1, 2 \& 3) will investigate 6 different dose levels of RV568 given as a single dose and Part B (Cohorts 4 \& 5) will investigate 2 different dose levels of RV568 given once a day for 14 days.
- Conditions
- COPD, Healthy Volunteers
- Being tested
- RV568 single dose, RV568 matching placebo single dose, RV568 repeat dose, RV568 matching placebo 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.
RV568 single doseDrug
Safety and tolerability of single escalating doses in normal human volunteers
RV568 matching placebo single doseDrug
Safety and tolerability of escalating repeat doses in normal human volunteers.
RV568 repeat doseDrug
Safety and tolerability of escalating repeat doses in normal human volunteers.
RV568 matching placebo repeat doseDrug
Safety and tolerability of escalating repeat doses in normal human volunteers.
| Study group | Role | What they receive |
|---|---|---|
| Part A - Single dose escalation | Experimental | Not described Receives: Drug: RV568 single dose; Drug: RV568 matching placebo single dose |
| Part B - 14 day repeat dose escalation | Experimental | Not described Receives: Drug: RV568 repeat dose; Drug: RV568 matching placebo 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, 56 days; Cohorts 2 & 3, 28 days; Cohorts 4 & 5, 35 days
ECG assessment
Change from pre-dose values.
Measured: Cohort 1, 56 days; Cohorts 2 & 3, 28 days; Cohorts 4 & 5, 35 days
Vital signs assessment
Change from pre-dose values
Measured: Cohort 1, 56 days; Cohorts 2 & 3, 28 days; Cohorts 4 & 5, 35 days
Spirometry assessment
Change from pre-dose values
Measured: Cohort 1, 56 days; Cohorts 2 & 3, 28 days; Cohorts 4 & 5, 35 days
Secondary outcomes (1)
Plasma RV568 levels
Measured: Cohorts 1, 2 & 3: Day 1 (0, 15, 30 & 45 min and 1, 2, 4, 6, 8, 10, 12 and 24 h), then 7, 14 and 28 days. Cohorts 4 & 5: Day 1, 7 & 14 (0, 15, 30 & 45 min and 1, 2, 4, 6, 8, 10, 12 and 24 h), Day 10, 11, 12 & 13 (0 & 30 min), then Day 21, 28 and 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Respivert Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Garth Rapeport, Study director, Respivert Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01661244
- Sponsor's protocol ID
- RVH007
- Status last verified
- Mar 2013
- First submitted
- 7 Aug 2012
- Last updated
- 4 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Two Part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Treatment With Single and Repeat Doses of Inhaled RV568 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01661244
- Acronym / sponsor ID
- RVH007
- Conditions
- COPD, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Respivert LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 9 Aug 2012 (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.
RV568 is being developed as a possible treatment of smoking related lung disease (also known as Chronic Obstructive Pulmonary Disease - COPD).
The main purpose of this study is to examine the safety and tolerability of a new inhaled formulation of RV568 in healthy volunteers. The study will be run in two parts; Part A and Part B. Part A (Cohorts 1, 2 \& 3) will investigate 6 different dose levels of RV568 given as a single dose and Part B (Cohorts 4 \& 5) will investigate 2 different dose levels of RV568 given once a day for 14 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A - Single dose escalation | Experimental | Drug: RV568 single dose, Drug: RV568 matching placebo single dose |
| Part B - 14 day repeat dose escalation | Experimental | Drug: RV568 repeat dose, Drug: RV568 matching placebo repeat dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female between 18 and 65 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.
- Body weight ≥50 kg and body mass index within the range 19-29 kg/m2 (inclusive).
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Average QTc(B) or QTc(F) <450 msec (or QTc <480 msec in healthy subjects with right bundle branch block).
Key exclusion criteria (21 listed)
- Any acute or chronic illness or clinically relevant abnormality identified on the screening medical assessment, laboratory tests or ECG.
- Upper or lower respiratory tract infection within 4 weeks of the screening visit.
- 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 (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Positive urinary drugs or breath alcohol test at screening or prior to dosing.
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 |
|---|---|---|
| RV568 single doseSafety and tolerability of single escalating doses in normal human volunteers | Drug | Part A - Single dose escalation |
| RV568 matching placebo single doseSafety and tolerability of escalating repeat doses in normal human volunteers. | Drug | Part A - Single dose escalation |
| RV568 repeat doseSafety and tolerability of escalating repeat doses in normal human volunteers. | Drug | Part B - 14 day repeat dose escalation |
| RV568 matching placebo repeat doseSafety and tolerability of escalating repeat doses in normal human volunteers. | Drug | Part B - 14 day repeat dose escalation |
Primary outcome
Incidence of treatment emergent adverse events
Time frame: Cohort 1, 56 days; Cohorts 2 & 3, 28 days; Cohorts 4 & 5, 35 days
Assessment of the number of adverse events reported by subjects following dosing.
ECG assessment
Time frame: Cohort 1, 56 days; Cohorts 2 & 3, 28 days; Cohorts 4 & 5, 35 days
Change from pre-dose values.
Vital signs assessment
Time frame: Cohort 1, 56 days; Cohorts 2 & 3, 28 days; Cohorts 4 & 5, 35 days
Change from pre-dose values
Spirometry assessment
Time frame: Cohort 1, 56 days; Cohorts 2 & 3, 28 days; Cohorts 4 & 5, 35 days
Change from pre-dose values
1 secondary outcome
Plasma RV568 levels
Time frame: Cohorts 1, 2 & 3: Day 1 (0, 15, 30 & 45 min and 1, 2, 4, 6, 8, 10, 12 and 24 h), then 7, 14 and 28 days. Cohorts 4 & 5: Day 1, 7 & 14 (0, 15, 30 & 45 min and 1, 2, 4, 6, 8, 10, 12 and 24 h), Day 10, 11, 12 & 13 (0 & 30 min), then Day 21, 28 and 35
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 4 Mar 2013.
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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.
Dr Garth Rapeport study director
Respivert 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 RV568 single dose and RV568 repeat dose in people with 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 10 inclusion and 21 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 4 Mar 2013. 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: Cohort 1, 56 days; Cohorts 2 & 3, 28 days; Cohorts 4 & 5, 35 days). The study lists 4 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 2013.