EUCTR2014-003077-42-GB进行中（未招募）1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 26
排除标准
- •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.
- •11. Required current use of drugs with narrow therapeutic indices that are principally metabolized by CYP3A4 or transported by P-glycoprotein (P-gp), for which a drug interaction with solithromycin could result in higher and possibly unsafe exposures to these drugs: e.g. the P-gp substrates digoxin or colchicine and the CYP3A4 substrates alfentanil, astemizole, cisapride, cyclosporine, dihydroergotamine, ergotamine, fentanyl, midazolam, pimozide, quinidine, sirolimus, tacrolimus, everolimus, and terfenadine).
- •12. History of organ transplant.
- •13. Cytotoxic chemotherapy or radiation therapy within the previous 3 months.
- •14. Known neuromuscular disorder from clinical history (e.g. myasthenia gravis, Parkinson’s disease).
- •15. Known significant renal, hepatic, or hematologic impairment.
- •16. Women who are pregnant or breast feeding
- •17. Prior participation in this protocol.
- •18. Any investigational drugs taken or investigational devices used within 4 weeks before administration of the first dose of the study drug.
- •19. History of intolerance or hypersensitivity to macrolide antibiotics.
- •20. Any concomitant condition that, in the opinion of the Investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy and follow-up could be completed (e.g. life expectancy <30 days).
研究者
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