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A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of PC945

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02715570
Recruitment Status : Completed
First Posted : March 22, 2016
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Pulmocide Ltd

Brief 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

Condition or disease Intervention/treatment Phase
Aspergillosis Drug: PC945 - single doses Drug: Placebo - single doses Drug: PC945 - repeat doses Drug: Placebo - repeat doses Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : October 23, 2017
Actual Primary Completion Date : April 27, 2018
Actual Study Completion Date : April 27, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis

Arm Intervention/treatment
Experimental: Single dose - healthy volunteers Drug: PC945 - single doses
Safety and tolerability of single doses

Drug: Placebo - single doses
Safety and tolerability of single doses

Experimental: Repeat dose - healthy volunteers Drug: PC945 - repeat doses
Safety and tolerability of repeat doses

Drug: Placebo - repeat doses
Safety and tolerability of repeat doses

Experimental: Single dose - asthmatic patients Drug: PC945 - single doses
Safety and tolerability of single doses

Drug: Placebo - single doses
Safety and tolerability of single doses




Primary Outcome Measures :
  1. 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

  2. 12-lead ECG assessment [ Time Frame: Cohort 1 - 12 weeks; Cohort 2 - 7 weeks; Cohort 3 - 6 weeks ]
    Change from pre-dose values

  3. 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

  4. 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

  5. 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


Secondary Outcome Measures :
  1. 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 ]
    Blood levels of PC945 measured after dosing

  2. Spirometry assessment (FEV1) [ Time Frame: Cohort 3 only - Day 1, 8 hours ]
    Observed drops in FEV1 assessment after dosing patients with mild asthma


Other Outcome Measures:
  1. Determination of exogenous fungal flora [ Time Frame: Cohort 1 (4 treatment periods) & Cohort 3 (1 treatment period) Day1 = 1 sample; Day3 = 1 sample. Cohort 2, Day 1 = 1 sample; Day 9 = 1 sample ]
    Assessment of fungal flora found in mouth and throat after dosing



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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).
  • 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

Exclusion Criteria:

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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715570


Locations
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United Kingdom
Parexel EPCU
Harrow, Middlesex, United Kingdom, HA1 3UJ
Sponsors and Collaborators
Pulmocide Ltd
Investigators
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Principal Investigator: Muna Albayaty, MBChB, FFPM, MSc cro
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Responsible Party: Pulmocide Ltd
ClinicalTrials.gov Identifier: NCT02715570    
Other Study ID Numbers: PC_ASP_001
2015-003327-64 ( EudraCT Number )
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pulmocide Ltd:
Aspergillus species
Filamentous fungi
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Enzyme Inhibitors
Aspergillosis
Allergic Bronchopulmonary
Asthma
Additional relevant MeSH terms:
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Aspergillosis
Mycoses