Sponsor study identifier
interventional
24
1 country
1
Study Start
March 22, 2021
Actual (reported)Primary Completion
May 18, 2021
Actual (reported)Study Completion
September 30, 2021
Actual (reported)This is a Phase 1, single-center, open-label, single ascending dose study to assess the PK, safety, and tolerability of SYN-020 delayed release capsules administered orally to healthy adult male and female subjects with a BMI of 18.5 to 27 kg/m2. Up to 36 subjects will participate, in each of up to 6 sequential cohorts. Single doses of 5, 15, 45, and 150 mg SYN-020 are planned in Cohorts 1 through 4, respectively. Cohorts 5 and 6, if enrolled, will receive doses that were well tolerated in an earlier cohort to determine the effect of BMI and/or a high-fat meal on the SYN-020 PK profile. For each cohort, eligible subjects will be admitted to the clinic on Day -1, and receive study drug in the morning of Day 1. For PK analysis, blood and feces will be collected before dosing and for up to 96 hours (blood) or 120 hours (feces) after dosing. Subjects will be discharged from the clinic after the End of Study procedures are completed on Day 6.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 12, 2021
Actual (reported)March 22, 2021
Actual (reported)March 25, 2021
Actual (reported)May 18, 2021
Actual (reported)September 30, 2021
Actual (reported)SYN-020 systemic absorption
Analysis of SYN-020 level present in blood
Daily Day 1 through Day 5
SYN-020 presence in feces
Analysis of SYN-020 level present in feces
Daily Day -1 through Day 6
Percentage of Participants with Changes in Clinical Laboratory Testing
Day -1, Day 2, Day 6
Number of Participants With Changes in Physical exam
Day 1 and Day 6
Number of Participants with Changes in Vital Signs
Daily Day -1 through Day 6
Number of Participants with Changes in Electrocardiograms
Day -1, Day 1, Day 2, Day 6
Immunogenicity testing
Day 1, Day 6
6 subjects to receive a single 5 mg dose of SYN-020
6 subjects to receive a single 15 mg dose of SYN-020
6 subjects to receive a single 45 mg dose of SYN-020
SYN-020, is an opaque, white, size 3 HPMC capsule for oral administration containing enteric-coated, delayed-release pellets.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Spaulding Clinical Research LLC
West Bend, Wisconsin, 53095, United States
Carlos Sanabria, MD
Spaulding Clinical Research LLC
24 participants (actual enrollment reported by the registry).
First Submitted
March 12, 2021
First Posted
March 25, 2021
Study Start
March 22, 2021
Actual (reported)6 subjects to receive a single 150 mg dose of SYN-020
Contact the study team to confirm eligibility.
Primary Completion
May 18, 2021
Actual (reported)Study Completion
September 30, 2021
Actual (reported)Last Updated
November 21, 2024
Record last verified: 2024-11
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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