Safety and PK of MBX-400 (Cyclopropavir) in Normal Volunteers
A Phase 1 Trial to Evaluate the Safety and Pharmacokinetics of Multiple Ascending Doses of MBX-400 in Healthy Volunteers
2 other identifiers
interventional
24
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Nov 2015
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2015
CompletedFirst Posted
Study publicly available on registry
May 27, 2015
CompletedStudy Start
First participant enrolled
November 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedDecember 26, 2017
July 19, 2017
1.4 years
May 14, 2015
December 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency of clinical and laboratory adverse events and serious adverse events related to the study product through Day 22.
Day 1 through Day 22
Secondary Outcomes (12)
Amount of drug excreted in urine with dose 1
Day 1 pre-dose, 0-4, 4-8, 8-12, and 12-24 hour collections
Amount of drug excreted in urine with dose 7
Day 7 pre-dose, 0-4, 4-8, 8-12, 12-24, 24-48, and 48-72 hour collections
Drug accumulation ratio
Between Days 1 and 7
Pharmacokinetic characteristics of MBX-400: amount excreted in urine (Ae)
Day 1 dose at baseline pre-dose and the following intervals: 0-4 hours, 4-8 hours, 8-12 hours, and 12-24 hours. Day 7 dose: baseline pre-dose and the following intervals: 0-4 hours, 4-8 hours, 8-12 hours, 12-24 hours, 24-48 hours, and 48-72 hours.
Pharmacokinetic characteristics of MBX-400: AUC0-inf
8 time-points over 24 hours after dosing on Day 1; immediately pre-dose and 2 hours after dosing on day 4; and on day 7 at 8 time-points over 24 hours, then at 30, 48, and 72 hours after dosing
- +7 more secondary outcomes
Study Arms (4)
1000mg MBX400
EXPERIMENTAL6 subjects receive 1000 mg MBX400 orally once per day for 7 days, 2 subjects receive Placebo orally once per day for 7 days
100mg MBX400
EXPERIMENTAL6 subjects receive 100 mg MBX400 orally once per day for 7 days, 2 subjects receive Placebo orally once per day for 7 days
350mg MBX400
EXPERIMENTAL6 subjects receive 350 mg MBX400 orally once per day for 7 days, 2 subjects receive Placebo orally once per day for 7 days
750mg MBX400
EXPERIMENTAL6 subjects receive 750 mg MBX400 orally once per day for 7 days, 2 subjects receive Placebo orally once per day for 7 days
Interventions
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.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Emory Vaccine Center - The Hope Clinic
Decatur, Georgia, 30030-1705, United States
Related Publications (1)
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.
PMID: 31285228DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2015
First Posted
May 27, 2015
Study Start
November 10, 2015
Primary Completion
April 1, 2017
Study Completion
December 1, 2017
Last Updated
December 26, 2017
Record last verified: 2017-07-19