Four phase 1 trials to evaluate the safety and pharmacokinetic profile of single and repeated dosing of SCO-101 in adult male and female volunteers
| العنوان: | Four phase 1 trials to evaluate the safety and pharmacokinetic profile of single and repeated dosing of SCO-101 in adult male and female volunteers |
|---|---|
| المؤلفون: | Nils Brünner, Nicklas L. Roest, Jan Stenvang, Tore Bjerregaard Stage, Troels K Bergmann, Jacobsen Thomas Amos, Peter M. Vestlev, Palle Christophersen |
| المصدر: | Bergmann, T K, Stage, T B, Stenvang, J, Christophersen, P, Jacobsen, T A, Roest, N L, Vestlev, P M & Brunner, N 2020, ' Four phase 1 trials to evaluate the safety and pharmacokinetic profile of single and repeated dosing of SCO-101 in adult male and female volunteers ', Basic & Clinical Pharmacology & Toxicology, vol. 127, no. 4, pp. 329-337 . https://doi.org/10.1111/bcpt.13466 Bergmann, T K, Stage, T B, Stenvang, J, Christophersen, P, Jacobsen, T A, Roest, N L, Vestlev, P M & Brünner, N 2020, ' Four phase 1 trials to evaluate the safety and pharmacokinetic profile of single and repeated dosing of SCO-101 in adult male and female volunteers ', Basic & Clinical pharmacology & Toxicology, vol. 127, no. 4, pp. 329-337 . https://doi.org/10.1111/bcpt.13466 Basic & Clinical Pharmacology & Toxicology |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | Adult, Male, Drug, media_common.quotation_subject, Cmax, Administration, Oral, Antineoplastic Agents, Pharmacology, Toxicology, Placebo, drug discovery and development, 030226 pharmacology & pharmacy, cancer chemotherapy, drug discovery, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, Double-Blind Method, Pharmacokinetics, Chloride Channels, Oral administration, safety pharmacology, discovery and development, Humans, Medicine, Adverse effect, development, media_common, business.industry, Safety pharmacology, Clinical Pharmacology, Phase 1 trials, drug, safety evaluation, General Medicine, CANCER, Healthy Volunteers, Area Under Curve, CELLS, Original Article, Female, ORIGINAL ARTICLES, business, pharmacokinetics, 030217 neurology & neurosurgery, RESISTANCE |
| الوصف: | SCO-101 (Endovion) was discontinued 20 years ago as a new drug under development against sickle cell anaemia. Data from the phase 1 studies remained unpublished. New data indicate that SCO-101 might be efficacious as add-on therapy in cancer. Thus, we report the results from the four phase 1 trials performed between 2001 and 2002. Adult volunteers received SCO-101 or placebo in four independent trials. Adverse events were recorded, and SCO-101 was determined for pharmacokinetic analysis. Ninety-two volunteers completed the trials. The most remarkable adverse effect was a transient and dose-dependent increase in unconjugated bilirubin. Plasma SCO-101 elimination was approximately log linear, with apparent oral clearances of between 315 and 2103 mL/h for single doses, and between 121 and 2433 mL/h at steady state following oral administration. There was a marked decrease in clearance with increasing dose, and for repeated dose versus single dose.T(max)was greater, andC(max)and AUC(infinity)were lower in the fed state compared to the fasted state. Exposure was equivalent in males and females and for African Americans and Caucasians. In conclusion, SCO-101 appears to be a safe drug with a predictable PK profile. Its efficacy as add-on to standard anticancer drugs has yet to be defined. |
| وصف الملف: | application/pdf |
| اللغة: | English |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7d41e0ff90bbb6f0ce3d727ddfe4da66 https://curis.ku.dk/portal/da/publications/four-phase-1-trials-to-evaluate-the-safety-and-pharmacokinetic-profile-of-single-and-repeated-dosing-of-sco101-in-adult-male-and-female-volunteers(e206d00c-8caf-49b6-af12-0b981d1cf13d).html |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....7d41e0ff90bbb6f0ce3d727ddfe4da66 |
| قاعدة البيانات: | OpenAIRE |
| الوصف غير متاح. |