A single-centre, double-blind, randomised, placebo-controlled crossover study to evaluate the effect of solithromycin on airway inflammation in male and female patients with chronic obstructive pulmonary disease. - A study to evaluate the effect of solithromycin in COPD

Imperial College, London0 sites6 target enrollmentJuly 24, 2015

ConditionsChronic Obstructive Pulmonary Disease.MedDRA version: 18.0 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Chronic Obstructive Pulmonary Disease.
Sponsor: Imperial College, London
Enrollment: 6
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 24, 2015

End Date

January 5, 2017

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Imperial College, London

Eligibility Criteria

Inclusion Criteria

•1\. Male and female patients greater than 45 years of age.
•2\. History of cigarette smoking more than 10 pack\-years.
•3\. FEV1/FVC of \<0\.70 and FEV1 of 30\-79% of the predicted normal value.
•4\. Patients on prescribed inhaled corticosteroids can be enrolled.
•5\. Females of non\-childbearing potential who are either surgically sterile (e.g. tubal ligation) or at least 2 years post\-menopausal.
•6\. Females of childbearing potential (including females less than 2 years post\-menopausal) who have a negative pregnancy test at enrollment and agree to use highly effective methods of birth control (i.e. diaphragm plus spermicide or male condom plus spermicide, oral contraceptive in combination with a second method, contraceptive implant, injectable contraceptive, indwelling intrauterine device, sexual abstinence, or a vasectomized partner) while participating in the study and for 30 days after the last dose of study drug.
•7\. The patient must be a suitable candidate for oral therapy and be able to swallow capsules intact.
•8\. No evidence of active bacterial infection in sputum by qPCR evaluation.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0

Exclusion Criteria

•1\. Acute exacerbation of COPD within the previous 60 days.
•2\. Any condition that could possibly affect oral drug absorption, e.g. gastroenteritis, status post gastrectomy, status post bariatric surgery.
•3\. Currently taking medication for HIV, chronic hepatitis B, or hepatitis C virus (HCV) infection.
•4\. Currently taking theophylline or other xanthine medication.
•5\. Currently taking warfarin.
•6\. Known concomitant infection which would require additional systemic antibiotics.
•7\. QTc greater than 470 msec as corrected by the Fridericia formula.
•8\. Current use of drugs known to prolong the QT interval, including Class Ia (quinidine, procainamide) or Class III (amiodarone, sotalol) antiarrhythmics.
•9\. Concomitant use of drugs, foods, or herbal products known to be moderate to potent inhibitors of CYP3A4 isozymes: oral antifungal agents (e.g. ketoconazole, itraconazole, posaconazole, fluconazole and voriconazole); HIV protease inhibitors (e.g. ritonavir and saquinavir), HCV protease inhibitors (e.g. boceprevir and telaprevir), nefazodone, fluvoxamine, conivaptan, diltiazem, verapamil, aprepitant, ticlopidine, crizotinib, imatinib; grapefruit or grapefruit juice.
•10\. Any use within the prior 7 days of drugs or herbal products known to be moderate to potent inducers of CYP3A4 isozymes: St. John’s Wort, rifampin, rifabutin, anti\-convulsants (e.g. phenobarbital, carbamazepine, phenytoin, rufinamide), modafinil, armodafinil, etraverine, efavirenz, bosentan.