Safety and PK of MBX-400 (Cyclopropavir) in Normal Volunteers

Summary

This is a phase I safety, PK and food effect study of the CMV drug. In part 1 of the study, subjects will receive one of four dosage strengths of MBX-400 (100 mg once daily, 350 mg once daily; 750 mg once daily; and 1000 once daily) for 7 days and safety and PK will be assessed. Subjects must be 18 to 65 years of age, male or female; if female, be surgically-sterilized or post-menopausal; if male, have undergone vasectomy; have a body mass index (BMI) of 18 to 32 kg/m\^2; not be a user of nicotine-containing products; be willing to abstain from nicotine-containing products, alcohol and illicit drugs during the study. Subjects will be followed for 28 days post dosing.

Timeline

Start

2015-11-10

Primary completion

2017-04-01

Completion

2017-12-01

Publications

• Rouphael NG, Hurwitz SJ, Hart M, Beck A, Anderson EJ, Deye G, Osborn B, Cai SY, Focht C, Amegashie C, Bowlin TL, Brooks J, Mulligan MJ. Phase Ib Trial To Evaluate the Safety and Pharmacokinetics of Multiple Ascending Doses of Filociclovir (MBX-400, Cyclopropavir) in Healthy Volunteers. Antimicrob Agents Chemother. 2019 Aug 23;63(9):e00717-19. doi: 10.1128/AAC.00717-19. Print 2019 Sep.

Drugs

Indications