Chemical Class:
February 25, 2016: AstraZeneca has removed AZD-5847 from development. 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.