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Working Group on New TB Drugs

Stop TB Partnership

Drug Pipeline

AZD5847 Oxazolidinone
Last Updated: 2-Sep-2015




Project Info

Submitted for registration to a stringent regulatory authority (FDA, EMA, WHO pre-qualification Yes

Project advancing to the next stage Q4 2015

Project type New chemical entity (NCE)

Clinical project description The Phase 2 EBA trial has been completed but not yet published. The initial objectives of the project were: 1. To assess the safety and tolerability of AZD5847 after receiving oral doses on a single day (Part A) or after receiving a single oral dose in two periods (Part B). For volunteers in Part B, the effect of food on the PK of AZD5847 will also be studied. 2.To determine the safety, tolerability and blood levels of AZD5847 in healthy volunteers after daily oral dosing for 14 days. The Purpose of the Phase IIb study is to assess the early bacterial activity (EBA) from day 0 to day 14 of Astra Zeneca Drug (AZD5847) at four different doses and schedules (500 mg once daily, 500 mg twice daily, 1200 mg once daily, and 800 mg twice daily) in subjects with newly-diagnosed sputum smear positive pulmonary TB. A total of 75 subjects will be enrolled, with 15 randomized to each AZD5847 study arm or standard treatment with Rifafour. Duration of drug treatment is 14 days.




Clinical Trials

Trial Name: Single Dose, Phase 1
Primary Sponsor: AstraZeneca
Trial ID / Reg # / URL: NCT01037725 / NCT01037725 / https://clinicaltrials.gov/show/NCT01037725
Study Director Trial Status Start Date (First Patient In) Enrollment (as of Last Update) Target Enrollment
Andrew Shaw published December 2009 56
Trial Name: Multiple Dose, Phase 1
Primary Sponsor: AstraZeneca
Trial ID / Reg # / URL: NCT01116258 / NCT01116258 / https://clinicaltrials.gov/show/NCT01116258
Study Director Trial Status Start Date (First Patient In) Enrollment (as of Last Update) Target Enrollment
Andrew Shaw published March 2010 60
Trial Name: Randomized, Open Label, Multiple Dose Phase 2a Study of the Early Bactericidal Activity of AZD5847 in Adults With Pulmonary Tuberculosis
Primary Sponsor: NIAID, AstraZeneca
Trial ID / Reg # / URL: NCT01516203 / NCT01516203 / http://clinicaltrials.gov/ct2/show/NCT01516203
Study Director Trial Status Start Date (First Patient In) Enrollment (as of Last Update) Target Enrollment
Andreas Diacon in data analysis December 2012 75

Related links

AstraZeneca presentation at 2011 WGND Annual Meeting

Wookey A, Turner PJ, Greenhalgh JM, Eastwood M, Clarke J, Sefton C. 2004.AZD2563, a novel oxazolidinone: definition of antibacterial spectrum, assessment of bactericidal potential and the impact of miscellaneous factors on activity in vitro.Clin Micr

Balasubramanian V et al. 2014. Activity and mechanism of AZD5847. Antimicrob Agents Chemother. 2014;58(1):495-502. doi: 10.1128/AAC.01903-13. Epub 2013 Nov 4. PMID: 24189255

Balasubramanian V et al. 2014. PK PD in mice AZD5847. Antimicrob Agents Chemother. Jul;58(7):4185-90. doi: 10.1128/AAC.00137-14. Epub 2014 May 12. PMID: 24820085

Coleman MV et al. 2014. PET/CT imaging.Sci Transl Med. Dec 3;6(265):265