Safety and PK of MBX-400 (Cyclopropavir) in Normal Volunteers
Condition: Cytomegalovirus Infection
MeSH terms: Cytomegalovirus Infections
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      Cytomegalovirus (CMV) is a common cause of viral illness in children and adults. CMV is also
      an important congenital infection with complications including deafness, developmental delay,
      and cerebral palsy. The proposed study design is a standard multiple ascending dose
      escalation study. Four cohorts of 8 subjects each (6 active; 2 placebo) will be enrolled
      sequentially. MBX-400 will be administered orally once daily for 7 days, in the form of
      capsules, by study staff while the subject is an inpatient in a research unit. The study
      doses will be 100, 350, 750, and 1,000 mg daily. Up to 32 healthy male and female
      (non-pregnant, non-lactating) volunteers ages 18-65 in one site, will be consented and
      allowed to participate in the study if upon screening they meet the inclusion/exclusion
      criteria. Subjects will be enrolled into one of four sequential cohorts groups: Cohort 1 will
      receive 100 mg PO once daily for 7 days, Cohort 2 will receive 350 mg PO once daily for 7
      days, Cohort 3 will receive 750 mg PO once daily for 7 days, and Cohort 4 will receive 1000
      mg PO once daily for 7 days of MBX-400. Two members of each cohort will receive placebo. The
      study duration for each subject is expected to be approximately 80 days (screening period,
      administration of daily dose, and follow-up). Each subject may be admitted to the unit 1 day
      prior to the first dose, and will remain in the unit until the day after the 7th daily dose.
      Subjects will return for follow-up visits after the last dose. Safety, tolerability, and
      pharmacokinetics will be assessed. The overall study duration across all study groups is
      expected to be approximately 18 months. The primary objective evaluate the safety and
      tolerability of multiple ascending doses of 100, 350, 750, and 1000 mg PO once daily for 7
      days of MBX-400 in healthy subjects. The secondary objective determine the plasma and urine
      pharmacokinetic profile of multiple doses of 100, 350, 750, and 1000 mg PO once daily for 7
      days of MBX-400 in healthy subjects.
    

Intervention name(s): MBX400; Placebo
Intervention type(s): Drug; Other
Intervention description(s): MBX-400, a white to off-white crystalline powder, will be given orally x 7 days to 4 cohorts. Cohort 1 receives 100 mg/day, Cohort 2 receives 350 mg, Cohort 3 receives 750 mg, Cohort 4 receives 1000 mg.; Placebo capsules are supplied as white opaque, hard gelatin capsules filled with microcrystalline cellulose. 2 subjects from each cohort receive Placebo orally once per day x 7 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: antiviral; ascending dose; Cytomegalovirus; food effect; Herpesviridae; MBX-400