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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02919995 |
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Date of registration:
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21/09/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study of RPL554 in Patients With Cystic Fibrosis
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Scientific title:
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A Phase IIa, Randomised, Double Blind, Placebo Controlled, Three Way Crossover Study to Assess the Pharmacokinetics of RPL554 Administered to Adult Patients With Cystic Fibrosis. |
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Date of first enrolment:
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February 8, 2017 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02919995 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Andres Floto |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cambridge Centre for Medical Research, Papworth Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 1. 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.
2. Male or female aged =18 years at the time of informed consent. Females of
childbearing potential must have been using a consistent and reliable form of
contraception (see Appendix 1) from the last menses before the first study treatment
administration, and must commit to continue to do so during the study and for 3 months
after the last dose of study treatment.
3. Have a 12-lead ECG recording at screening (Visit 1) and Visit 2 pre-dose showing
the following:
- Heart rate between 45 and 90 beats per minute
- QT interval corrected for heart rate using Fridericia's formula (QTcF) interval
=450 msec
- QRS interval =120 msec
- PR interval =220 msec
- No clinically significant abnormality including morphology (e.g. left bundle
branch block, atrioventricular nodal dysfunction, ST segment abnormalities) 4.
Capable of complying with all study restrictions and procedures including ability
to use the study nebuliser correctly.
5. Body mass index (BMI) between 18 and 30 kg/m2 (inclusive) with a minimum
weight of 40 kg.
6. Patients with a genetic diagnosis of CF. 7. Spirometry at screening
demonstrating an FEV1 =40% and =80% of predicted normal.
8. Capable of withdrawing from long acting bronchodilators1 until the end of the
treatment period, and short acting bronchodilators for 8 hours prior to
administration of study treatment.
9. Clinically stable CF in the 2 weeks prior to randomisation (Visit 2).
Exclusion Criteria:
1. History of cirrhotic liver disease or portal hypertension.
2. CF exacerbation requiring hospitalisation in the month prior to screening (Visit 1) or
prior to randomisation (Visit 2).
3. Use of oral or intravenous antibiotics (in additional to usual maintenance therapy) in
the 2 weeks prior to screening (Visit 1) or randomisation (Visit 2).
4. Other non-CF related respiratory disorders: Patients with a current diagnosis of
active tuberculosis, lung cancer, sarcoidosis, sleep apnoea, known alpha-1 antitrypsin
deficiency or other active pulmonary diseases.
5. Previous lung resection or lung transplant.
6. History of, or reason to believe a patient has, drug or alcohol abuse within the past
3 years.
7. Received an experimental drug within 3 months or five half-lives, whichever is longer.
8. Patients with a history of chronic uncontrolled disease including, but not limited to,
cardiovascular (including arrhythmias), endocrine, active hyperthyroidism,
neurological, hepatic, gastrointestinal, renal, haematological, urological,
immunological or ophthalmic diseases that the Investigator believes are clinically
significant.
9. Documented cardiovascular disease: angina, recent or suspected myocardial infarction,
congestive heart failure, a history of unstable, or uncontrolled hypertension, or has
been diagnosed with hypertension in last 3 months.
10. Has had major surgery, (requiring general anaesthesia) in the 6 weeks prior to
screening (Visit 1) or will not have fully recovered from surgery, or planned surgery
through the end of the study.
11. Infection with nontuberculous mycobacteria, methicillin-resistant Staphylococcus
aureus (MRSA), or Burkholderia species.
12. Use of immune-suppression; long term use of prednisolone =10 mg/day.
13. History of malignancy of any organ system within 5 years with the exception of
localised skin cancers (basal or squamous cell).
14. Clinically significant abnormal values for safety laboratory tests (haematology,
biochemistry or urinalysis) at screening (Visit 1), as determined by the Investigator.
15. A disclosed history or one known to the Investigator, of significant non-compliance in
previous investigational studies or with prescribed medications.
16. Requires oxygen therapy, even on an occasional basis.
17. Pregnancy or lactation (female subjects only).
18. Any other reason that the Investigator considers makes the patient unsuitable to
participate. -
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Drug: Placebo
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Drug: RPL554
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Primary Outcome(s)
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AUC by Dose
[Time Frame: Pre dose, 15 and 30 minutes and 1, 2, 4, 6, 8 and 24 hours post dose after each treatment]
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Maximum Plasma Concentration After Each Dose
[Time Frame: Pre dose, 15 and 30 minutes and 1, 2, 4, 6, 8 and 24 hours post dose]
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Half Life for Each Dose
[Time Frame: Pre dose, 15 and 30 minutes and 1, 2, 4, 6, 8 and 24 hours post dose]
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Time to Maximum Plasma Concentration After Each Dose
[Time Frame: Pre dose, 15 and 30 minutes and 1, 2, 4, 6, 8 and 24 hours post dose]
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Secondary Outcome(s)
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FVC
[Time Frame: Over 24 hours after treatment]
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Laboratory Safety Tests 2
[Time Frame: Screening and end of study]
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AUC FEV1(0-6h)
[Time Frame: Pre dose and 15 and 30 minutes and 1, 2, 4 and 6 hours post dose]
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ECG 2
[Time Frame: Over 8 hours after treatment]
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Laboratory Safety Tests 1
[Time Frame: Screening and end of study]
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Vital Signs 2
[Time Frame: Over 8 hours after treatment]
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Breath Samples
[Time Frame: 8 and 24 hours after treatment]
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Vital Signs 1
[Time Frame: Over 8 hours after treatment]
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ECG 1
[Time Frame: Over 8 hours after treatment]
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AUC FEV1(0-4h)
[Time Frame: Pre dose and 15 and 30 minutes and 1, 2 and 4 hours post dose]
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AUC FEV1(0-8h)
[Time Frame: pre dose and 15 and 30 minutes and 1, 2, 4, 6 and 8 hours post dose]
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Peak FEV1 for Each Treatment
[Time Frame: Pre dose and 15 and 30 minutes and 1, 2 and 4 hours post dose after treatment]
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Laboratory Safety Tests 3
[Time Frame: Screening and end of study]
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Secondary ID(s)
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RPL554-010-2015
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2015-004263-36
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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