Safety and PK of MBX-400 (Cyclopropavir) in Normal Volunteers
Status:
Completed
Trial end date:
2017-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)