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

NCT02454699 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-12-26

No results posted yet for this study

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.

Conditions

  • Cytomegalovirus Infection

Interventions

DRUG

MBX400

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.

OTHER

Placebo

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.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-10
Primary Completion
2017-04-01
Completion
2017-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02454699 on ClinicalTrials.gov