AspergillosisPhase 1NCT02715570
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of PC945
A Phase 1 study testing PC945 - single doses and PC945 - repeat doses in people with Aspergillosis, run by Pulmocide Ltd at 1 site in United Kingdom.
Trial summary
PC945 is a new medicine being developed for treatment of fungal lung diseases. The main purpose of this study is to investigate the safety, tolerability and pharmacokinetics of single and repeat doses of PC945 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Aspergillosis
- What is being tested?
- PC945 - single doses and PC945 - repeat doses
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Oct 2017to 27 Apr 2018
- 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
- All subjects (Cohorts 1, 2 \& 3)
- Male or female, aged between 18 and 65 years inclusive (at the time of consent) who fit one of the following criteria: Women of childbearing potential who are willing and able to use required contraception from screening until 30 days after receipt of the final dose; Women of non-childbearing potential defined as being amenorrhoeic or have been permanently sterilised; Men who are willing and able to use required contraception from the time of the first dose, until 90 days after receipt of the final dose of study medication.
- Females with a negative pregnancy test at screening and at Day -1.
- Willing and able to adhere to the restrictions and prohibitions required by this protocol.
- Signed informed consent form.
- Body weight ≥ 50 kg and body mass index (BMI) within the range 18 - 30 kg/m2 (inclusive).
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- Average QTcF <450 msec at screening and pre-dose.
- Vital signs assessments within normal ranges
- Healthy Subjects (Cohorts 1 and 2)
- Healthy as determined by a physician based on a full medical examination.
- Spirometry readings (FEV1 and FVC) to be ≥ 80% of predicted value and FEV1/FVC ratio > 0.7 at screening.
- Subjects with Asthma (Cohort 3)
- Diagnosis of asthma.
- Positive result to methacholine challenge at the screening visit.
- FEV1 >60% of predicted normal value at screening.
- Stable asthma based on physician assessment at screening, with no changes 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
- Otherwise healthy on the basis of a full medical examination at screening
Who cannot join
- All subjects (Cohorts 1, 2 \& 3)
- Any acute illness.
- Upper or lower respiratory tract infection within 4 weeks of the screening visit or randomisation.
- Use of prescription medications within 14 days of the Screening visit.
- Taking over the counter (OTC) medications other than vitamins or multivitamins, within 14 days prior to Screening.
- History of regular alcohol consumption within 6 months of the study with average weekly intake of >21 units for males, or >14 units for females.
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- History of drug or alcohol abuse within the previous 5 years.
- Smoker (regular or irregular), or has smoked or used nicotine-containing products (including e-cigarettes) within the 6 months prior to screening or has a smoking history of ≥ 10 pack years.
- Positive test for HIV-1 \& -2 antibodies at screening.
- Positive pre-study hepatitis B surface antigen or positive hepatitis C antibody result at screening.
- Positive test for alcohol, smoking or drugs of abuse at screening or Day -1.
- Received an experimental drug or used an experimental medical device within last 3 months.
- Allergy to any of the active or inactive ingredients in the study medication.
- Donation of blood in excess of 500 mL within a 3 month period prior to dosing, or if study participation would result in blood loss in excess of 500 mL in a 3 month period.
- Mentally or legally incapacitated.
- An employee of the Sponsor or contract research organisation (CRO), or a relative of an employee of the Sponsor or CRO.
- Unable or unwilling to undergo multiple venepuncture procedures or poor access to veins suitable for cannulation.
- Pregnant or lactating female
- Healthy subjects (Cohorts 1 and 2)
- Any chronic illness or clinically relevant abnormality identified on the screening medical assessment, laboratory tests or ECG.
- Subjects with asthma (Cohort 3)
- Had an episode of life-threatening asthma.
- Presence of clinically significant diseases other than asthma, hyper-responsive airways, seasonal allergic rhinitis or atopic diseases.
- Experienced an acute asthma exacerbation in the 12 months prior to screening requiring hospitalisation or accident and emergency treatment or management with systemic or injectable steroids.
- Uncontrolled, or moderate to severe asthma based on PI assessment and/or use of prohibited medications, or has required treatment with these therapies in the previous 12 weeks.
- History or presence of any known conditions contraindicated for methacholine challenge.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Single-blind, Placebo-controlled, Study to Assess the Safety and Tolerability of Single Escalating and Repeat, Inhaled Doses of PC945 in Healthy Subjects Combined With a Randomised, Single-blind, Placebo-controlled, Parallel Group to Assess the Safety and Tolerability of a Single Dose of Inhaled PC945 in Subjects With Mild Asthma
PC945 is a new medicine being developed for treatment of fungal lung diseases. The main purpose of this study is to investigate the safety, tolerability and pharmacokinetics of single and repeat doses of PC945
- Conditions
- Aspergillosis
- Being tested
- PC945 - single doses, Placebo - single doses, PC945 - repeat doses, Placebo - repeat doses
- Keywords
- Aspergillus species, Filamentous fungi, 14-alpha Demethylase Inhibitors, Anti-Infective Agents, Antifungal Agents, Enzyme Inhibitors, Aspergillosis, Allergic Bronchopulmonary, Asthma
- Medical subject headings
- Aspergillosis, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PC945 - single dosesDrug
Safety and tolerability of single doses
Placebo - single dosesDrug
Safety and tolerability of single doses
PC945 - repeat dosesDrug
Safety and tolerability of repeat doses
Placebo - repeat dosesDrug
Safety and tolerability of repeat doses
| Study group | Role | What they receive |
|---|---|---|
| Single dose - healthy volunteers | Experimental | Not described Receives: Drug: PC945 - single doses; Drug: Placebo - single doses |
| Repeat dose - healthy volunteers | Experimental | Not described Receives: Drug: PC945 - repeat doses; Drug: Placebo - repeat doses |
| Single dose - asthmatic patients | Experimental | Not described Receives: Drug: PC945 - single doses; Drug: Placebo - single doses |
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 number of adverse events reported by subjects following dosing
Measured: Cohort 1 - 12 weeks; Cohort 2 - 7 weeks; Cohort 3 - 6 weeks
12-lead ECG assessment
Change from pre-dose values
Measured: Cohort 1 - 12 weeks; Cohort 2 - 7 weeks; Cohort 3 - 6 weeks
Vital signs assessment (blood pressure and heart rate - measured together)
Change for pre-dose values
Measured: Cohort 1 - 12 weeks; Cohort 2 - 7 weeks; Cohort 3 - 6 weeks
Clinical laboratory assessments (blood and urine samples - measured together)
Change from pre-dose values
Measured: Cohort 1 - 12 weeks; Cohort 2 - 7 weeks; Cohort 3 - 6 weeks
Spirometry assessment (FEV1 & FVC - measured together)
Change from pre-dose values
Measured: Cohort 1 - 12 weeks; Cohort 2 - 7 weeks; Cohort 3 - 6 weeks
Secondary outcomes (2)
Plasma concentration data of PC945
Blood levels of PC945 measured after dosing
Measured: Cohort 1 (4 treatment periods) & Cohort 3 (1 treatment period) Day1 = 8 samples; Day2 = 2 samples; Day3 = 1 sample; F/U = 1 sample. Cohort 2 - Days1&7 = 10 samples; Days2,5,6 = 1 sample; Day8 = 2 samples; Day9 = 1 sample; F/U = 1 sample
Spirometry assessment (FEV1)
Observed drops in FEV1 assessment after dosing patients with mild asthma
Measured: Cohort 3 only - Day 1, 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2016 (estimated)
- Study start23 Oct 2017
- Primary completion27 Apr 2018
- Study completion27 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AspergillosisStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulmocide Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Muna Albayaty, MBChB, FFPM, MSc, Principal investigator, cro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02715570
- Sponsor's protocol ID
- PC_ASP_001
- Other IDs
- 2015-003327-64, 2015
- Status last verified
- Apr 2018
- First submitted
- 16 Mar 2016
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Single-blind, Placebo-controlled, Study to Assess the Safety and Tolerability of Single Escalating and Repeat, Inhaled Doses of PC945 in Healthy Subjects Combined With a Randomised, Single-blind, Placebo-controlled, Parallel Group to Assess the Safety and Tolerability of a Single Dose of Inhaled PC945 in Subjects With Mild Asthma
- ClinicalTrials.gov ID
- NCT02715570
- Acronym / sponsor ID
- PC_ASP_001
- Conditions
- Aspergillosis
- Keywords
- Aspergillus species, Filamentous fungi, 14-alpha Demethylase Inhibitors, Anti-Infective Agents, Antifungal Agents, Enzyme Inhibitors, Aspergillosis, Allergic Bronchopulmonary
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Pulmocide LtdIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2017 (actual)
- Primary completion
- 27 Apr 2018 (actual)
- Study completion
- 27 Apr 2018 (actual)
- First posted
- 22 Mar 2016 (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.
PC945 is a new medicine being developed for treatment of fungal lung diseases. The main purpose of this study is to investigate the safety, tolerability and pharmacokinetics of single and repeat doses of PC945
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single dose - healthy volunteers | Experimental | Drug: PC945 - single doses, Drug: Placebo - single doses |
| Repeat dose - healthy volunteers | Experimental | Drug: PC945 - repeat doses, Drug: Placebo - repeat doses |
| Single dose - asthmatic patients | Experimental | Drug: PC945 - single doses, Drug: Placebo - single doses |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- All subjects (Cohorts 1, 2 \& 3)
- Male or female, aged between 18 and 65 years inclusive (at the time of consent) who fit one of the following criteria: Women of childbearing potential who are willing and able to use required contraception from screening until 30 days after receipt of the final dose; Women of non-childbearing potential defined as being amenorrhoeic or have been permanently sterilised; Men who are willing and able to use required contraception from the time of the first dose, until 90 days after receipt of the final dose of study medication.
- Females with a negative pregnancy test at screening and at Day -1.
- Willing and able to adhere to the restrictions and prohibitions required by this protocol.
- Signed informed consent form.
Key exclusion criteria (26 listed)
- All subjects (Cohorts 1, 2 \& 3)
- Any acute illness.
- Upper or lower respiratory tract infection within 4 weeks of the screening visit or randomisation.
- Use of prescription medications within 14 days of the Screening visit.
- Taking over the counter (OTC) medications other than vitamins or multivitamins, within 14 days prior to Screening.
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 |
|---|---|---|
| PC945 - single dosesSafety and tolerability of single doses | Drug | Single dose - asthmatic patients, Single dose - healthy volunteers |
| Placebo - single dosesSafety and tolerability of single doses | Drug | Single dose - asthmatic patients, Single dose - healthy volunteers |
| PC945 - repeat dosesSafety and tolerability of repeat doses | Drug | Repeat dose - healthy volunteers |
| Placebo - repeat dosesSafety and tolerability of repeat doses | Drug | Repeat dose - healthy volunteers |
Primary outcome
Incidence of treatment emergent adverse events
Time frame: Cohort 1 - 12 weeks; Cohort 2 - 7 weeks; Cohort 3 - 6 weeks
Assessment of number of adverse events reported by subjects following dosing
12-lead ECG assessment
Time frame: Cohort 1 - 12 weeks; Cohort 2 - 7 weeks; Cohort 3 - 6 weeks
Change from pre-dose values
Vital signs assessment (blood pressure and heart rate - measured together)
Time frame: Cohort 1 - 12 weeks; Cohort 2 - 7 weeks; Cohort 3 - 6 weeks
Change for pre-dose values
Clinical laboratory assessments (blood and urine samples - measured together)
Time frame: Cohort 1 - 12 weeks; Cohort 2 - 7 weeks; Cohort 3 - 6 weeks
Change from pre-dose values
Spirometry assessment (FEV1 & FVC - measured together)
Time frame: Cohort 1 - 12 weeks; Cohort 2 - 7 weeks; Cohort 3 - 6 weeks
Change from pre-dose values
2 secondary outcomes
Plasma concentration data of PC945
Time frame: Cohort 1 (4 treatment periods) & Cohort 3 (1 treatment period) Day1 = 8 samples; Day2 = 2 samples; Day3 = 1 sample; F/U = 1 sample. Cohort 2 - Days1&7 = 10 samples; Days2,5,6 = 1 sample; Day8 = 2 samples; Day9 = 1 sample; F/U = 1 sample
Spirometry assessment (FEV1)
Time frame: Cohort 3 only - Day 1, 8 hours
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 1 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.
Muna Albayaty, MBChB, FFPM, MSc principal investigator
cro
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 PC945 - single doses and PC945 - repeat doses in people with Aspergillosis, run by Pulmocide 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 17 inclusion and 26 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 1 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. 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 - 12 weeks; Cohort 2 - 7 weeks; Cohort 3 - 6 weeks). 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 1 May 2018.